List of Abbreviations
CD – Crohn's disease
IAP – internal anal sphincter
MAFT – microinjective autologous fat transplantation
MRI – magnetic resonance imaging
NSAIDs – non-steroidal anti-inflammatory and antirheumatic drugs
RVF – rectovaginal fistula
US – ultrasound examination
Terms and Definitions
Recurrent RVF – the reappearance of a pathological communication between the rectum and the vagina some time after surgery that had a successful outcome, i.e., the absence of clinical symptoms of RVF (discharge of intestinal contents through the vagina) for a certain period of time.
Sphincter-sparing surgery – a procedure in which the sphincter apparatus of the rectum is not injured, or the impact on the sphincter apparatus is minimal and does not lead to a clinically significant impairment of fecal continence.
Tubular rectovaginal fistula – a fistula in which the vaginal mucosa transitions directly into the rectal mucosa.
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
RVF – a pathological communication between the rectum and the vagina [1].
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
The incidence of RVF does not exceed 5% of all rectal fistulas [1,2]. However, given the multi-etiological nature of the disease, the true number of patients with RVF remains unknown. True incidence rates are unknown because these patients still remain "multidisciplinary" and receive care in gynecological, proctological, general surgical inpatient departments, or are not treated at all.
The most common causes of RVF include:
Complicated labor (prolonged labor, perineal tears). It is known that 88% of rectovaginal fistulas occur after obstetric trauma, with perineal trauma followed by fistula formation noted in 0.1% of vaginal deliveries [2-8].
RVFs are perianal manifestations in patients with Crohn's disease (CD) in 2-23% of cases [9-12].
The incidence of RVF formation following low anterior resection of the rectum is 1.6-5.1% [13,14,15,16]. In recent years, the number of postoperative RVFs has significantly increased due to the use of various staplers in the surgical treatment of hemorrhoids and the use of synthetic implants in the surgical correction of pelvic organ prolapse [17,18]. The incidence of RVF formation after such surgical treatment is noted in 0.15% of cases [18,19].
1.3 Epidemiology of the Disease or Condition
The incidence rate of RVF is 0.1 cases per 10,000 population per year, and the prevalence of the disease is no more than 0.5 cases per 100,000 population [1,2,6,7].
Given the multi-etiological nature of the disease and the resulting lack of clear routing algorithms for this category of patients, the estimated number of patients with RVF is significantly higher. The disease most frequently develops in young women aged 20 to 40 years.
1.4 Features of Coding the Disease or Condition
Class – Diseases of the genitourinary system (XIV).
N82.3 – Colovaginal fistula.
1.5 Classification of the disease or condition
RVFs are classified:
By etiological factor:
Post-traumatic:
- postpartum
- foreign body injuries and sexual deviations [20]
- postoperative (resections of the rectum with or without stapled anastomoses or interintestinal anastomoses [13,14,15]); hemorrhoid surgery (stapled resection, etc. [19]); pelvic organ prolapse surgery (STARR, etc. [17,18]))
- following drainage of pelvic abscesses [21]
Perianal manifestations of CD [11,12]
Inflammatory (paraproctitis, bartholinitis) [1,21]
Tumor invasion [16]
Post-radiation [22-24]
Ischemic (local ischemia caused by the use of rectal suppositories with sympathomimetics (C05AX Other agents for topical treatment of hemorrhoids and anal fissures), non-steroidal anti-inflammatory and antirheumatic drugs (NSAIDs), etc.) [1].
According to the level of the fistula opening in the bowel, the following are distinguished [1]:
High RVF (the fistula opening is located above the dentate line in the rectum)
Low RVF (the fistula opening is located in the anal canal below and at the level of the dentate line).
Notes on formulation of the diagnosis.
When formulating the diagnosis, the etiology of the disease, the level of the fistula opening in the bowel (indicated only for high fistulas; for low fistulas, the relationship of the fistula tract to the anal sphincter is indicated), as well as the presence or absence of cavities, extensions along the fistula tract and their localization should be reflected. If the fistula is a manifestation of CD, the diagnosis of the underlying disease is fully stated first. Examples of diagnosis formulations are given below:
"Postpartum high rectovaginal fistula".
"Transsphincteric rectovaginal fistula with a subcutaneous extension".
"Postoperative recto(colo)vaginal fistula of the anastomosis zone".
"Post-radiation rectovaginal fistula".
"Crohn's disease in the form of colitis with involvement of the ascending, sigmoid, and rectum, chronic continuous course, severe form. Perianal manifestations in the form of a high rectovaginal fistula".
1.6 Clinical presentation of the disease or condition
The main clinical symptom of RVF is the discharge of intestinal contents through the vagina [1,6].
The clinical presentation of RVF can be extremely diverse. Patients may note discomfort, burning, itching, pain in the anus, vagina, and perineum. Vaginal discharge may be serosanguinous or purulent. In the presence of a purulent-inflammatory process in the rectovaginal septum or pararectal tissue (which, considering the anatomical features of the rectovaginal septum, is extremely rare), systemic inflammatory symptoms such as elevated body temperature and fever may appear. Also, especially with a prolonged history, symptoms of inflammatory diseases of the genitourinary system may manifest. Differential diagnosis should be carried out with fistulas between other parts of the gastrointestinal tract and female genital organs (enterocervical, enterovaginal fistulas), and urogenital fistulas.
2. Diagnostics, medical indications and contraindications for diagnostic methods
The diagnosis of RVF is established based on clinical and instrumental examination data.
2.1 Complaints and Anamnesis
In RVF, the most common complaints are the discharge of intestinal contents from the vagina, discomfort, burning, and itching in the perineal region. In the presence of a purulent-inflammatory process in the rectovaginal septum or pararectal tissue (noted extremely rarely), the appearance of a systemic inflammatory response is possible. With a prolonged history, symptoms of inflammatory diseases of the genitourinary system may manifest [1].
2.2 Physical Examination
All patients with suspected RVF are recommended to undergo an initial examination (consultation) by a coloproctologist and/or an initial examination (consultation) by an obstetrician-gynecologist, and/or an initial examination (consultation) by a surgeon with physical examination:
Visual inspection of external female genitalia, inguinal and perianal regions
bimanual vaginal examination
transrectal digital examination of the anal canal and rectum
probing of the fistula tract
GCR CLOE 5Grade of Recommendation C (Level of Evidence - 5).
Comment: The examination is performed on a gynecological chair with the patient in the supine position and legs maximally flexed toward the abdomen, or if not possible, in the lateral position. During external inspection of the perineal and anal regions, attention is paid to changes in the perianal skin, the shape of the anus, its gaping, the presence of scar changes and deformations, as well as the state of the inguinal lymph nodes. It is necessary to check the anal reflex.
Bimanual vaginal examination reveals the fistula opening in the vagina, assesses the level of the fistula opening, the severity of the scarring process, and the presence of purulent extensions in the rectovaginal septum and/or pelvic cavity.
During digital transrectal examination of the rectum, attention should be paid to the internal fistula opening (localization, width and shape, presence of inflammation and scars), concomitant diseases of the anal canal and the lower ampullary rectum (hemorrhoids, anal fissure, tumor process, etc.), and the condition of the anal sphincter apparatus is also assessed.
Probing of the fistula tract is performed to assess the topology of the fistula tract, its length, relationship to the anal canal and anal sphincter, and to determine the level of the fistula opening in the bowel.
2.3 Laboratory Diagnostics
Specific laboratory diagnostics for RVF are absent. Laboratory diagnostic tests should be performed in patients during the preparation and planning of surgical intervention to exclude concomitant diseases and conditions.
In case of a suspected tumor process, patients with RVF are recommended to undergo pathomorphological examination of biopsy (surgical) material (from the fistula tract and/or from the zone of the fistula opening in the vagina, bowel and/or the wall of the fistula tract) [1].
GoR CLoE 5Grade of Recommendation - C (Level of Evidence - 5)
In the presence of purulent discharge from the fistula openings, vagina, and/or rectum during an active purulent-inflammatory process, patients with suspected RVF are recommended to undergo microbiological (cultural) examination of the purulent discharge for aerobic and facultatively anaerobic microorganisms from the vagina and the fistula tract (if present) and determine their susceptibility to antimicrobial chemotherapeutic agents [1].
GCR CLOE 5Grade of Recommendation C (Level of Evidence - 5).
2.4 Instrumental Diagnostics
All patients older than 40 years to rule out colorectal neoplasms, or all patients with suspected IBD, are recommended to undergo colonoscopy to examine all parts of the colon and the terminal ileum [1,25-28].
GCR CLOE 5Grade of Recommendation C (Level of Evidence - 5).
Comment: the study is performed as an additional diagnostic method to assess the presence or absence of concomitant colonic diseases, inflammatory changes characteristic of Crohn's disease and ulcerative colitis, and to rule out colorectal neoplasms in patients older than 40 years.
All patients with RVF are recommended to undergo transrectal ultrasound of the rectum and/or pelvic magnetic resonance imaging with intravenous contrast to identify the fistula tract, definitively determine its topography relative to the vagina, rectum, and pelvic muscle structures, and to determine the presence and extent of purulent fluid collections [29-31].
GOM BLOE 2Grade of Recommendation - B (Level of Evidence - 2).
Comment: both methods have similar sensitivity and specificity in the diagnosis of RVF. Transrectal ultrasound of the rectum allows determining the nature of the fistula tract, its length, relation to the anal sphincter, and the presence and nature of purulent collections. It also reveals structural changes in the anal sphincter complex (ASC), the presence and extent of its defects, and the state of the pelvic floor muscles. The undeniable efficacy of transrectal rectal ultrasound in determining internal and external sphincter defects has been proven. Ultrasound is fairly simple to perform, inexpensive, and brief in duration. The disadvantage of the method is operator dependence. Performing MRI is advisable if there are contraindications to transrectal ultrasound of the rectum (narrowing and deformation of the anus, severe pain syndrome, etc.). MRI demonstrates high detail and is an operator-independent study. At the same time, MRI is an expensive study, requires the involvement of a radiologist, and takes more time.
All patients with RVF are recommended to undergo an examination of the sphincter apparatus of the rectum (sphincterometry) to determine the functional state of the muscular structures [32-34].
LoR CLoE 4Level of Recommendations — C (Level of Evidence — 4).
Comment: the study is most significant in patients with baseline anal sphincter dysfunction (previously operated on for anorectal diseases and in female patients with postpartum RVFs).
2.5 Other Procedures
No.
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
1. Conservative treatment
Surgery is the primary method of treatment for RVF. Isolated studies describe cases of spontaneous closure of previously unoperated RVFs in the presence of a narrow fistula tract (less than 0.3 cm), absence of purulent-inflammatory complications in the rectovaginal septum with restriction of passage in the fistula opening area (high enemas, diet); sanitation of the rectum and vagina; physical (curettage), chemical (alkaline solutions), biological (enzymatic preparations) methods applied to the fistula lining; use of autohemotherapy in the fistula area, etc. [35]. The studies were conducted on extremely small groups of patients, and long-term outcomes were not described [36,37].
All patients with RVF associated with Crohn's disease (CD) are recommended to undergo specific treatment aimed at controlling the underlying disease [9,11,38].
GCR BLOE 3Grade of Recommendation B (Level of Evidence - 3).
Comment: see clinical guidelines for "Crohn's Disease".
2. Surgical treatment
Choice of surgical method is determined taking into account the following characteristics:
1) etiology of the disease;
2) localization of the fistula tract relative to the external anal sphincter, as well as the state of the ASC and fecal continence function;
3) level of the fistula opening location in the rectum;
presence of purulent cavities and infiltrates in the rectovaginal septum and pararectal fat.
2.1 Surgical treatment of low-level RVF
Patients with low-level RVF with involvement of no more than 1/3 of the anal sphincter are recommended fistulotomy into the rectal lumen [34,39,40].
LoR CLoE 4Level of Recommendations — C (Level of Evidence — 4).
Comment: the efficacy of fistulotomy into the rectal lumen is quite high, ranging from 92% to 97%.
Patients with low-level RVF in the presence of concomitant anal sphincter insufficiency caused by an anal sphincter defect or cicatricial replacement of muscle tissue along the anterior semi-circumference are recommended fistula excision and sphincteroplasty [40].
LoR CLoE 4Level of Recommendations — C (Level of Evidence — 4).
Comment: cure of patients is achieved in 41-100% of cases.
2.2. Surgical treatment of high-level rectovaginal fistulas
Patients with high-level RVF are recommended elimination of the fistula by the "invagination" method [41-44].
LoR CLoE 4Level of Recommendations — C (Level of Evidence — 4).
Comment: the method is most reproducible in the absence of inflammatory and cicatricial changes of the rectovaginal septum in the area of the fistula tract, a fistula tract diameter of at least 7 mm (bougienage of the fistula tract is performed if necessary) and no more than 12 mm. The fistula tract from the vaginal opening is dissected down to the rectal wall as a "tube". Then, invagination of the fistula tract into the rectal lumen is performed. Cure of patients was noted in 63.2% of cases, and the method showed efficacy when reapplied in the event of RVF recurrence.
Patients with high-level RVF when the fistula opening is located no higher than 1 cm from the dentate line, with preserved anal sphincter function and an intact lower ampullary rectal wall are recommended to perform segmental proctoplasty (fistula excision with advancement of a muco-submucosal, muco-muscular, or full-thickness rectal flap into the anal canal) [45-48].
LoR CLoE 4Level of Recommendations — C (Level of Evidence — 4).
Comment: stepping back 0.5-1 cm distal to the internal fistula opening, a semilunar incision of the anal canal wall is made, occupying about 1/4-1/3 of the circumference. The flap is mobilized sharply in the proximal direction for 2-4 cm. Depending on the technique variant, the rectal wall flap can be muco-submucosal, muco-muscular, or full-thickness. The internal fistula opening is closed with 1-2 interrupted sutures, and then the flap is advanced distally and its edge is fixed to the underlying muscle structures of the anal canal wall and/or perianal skin without tension.
The rectal flap advancement procedure is sphincter-saving, as it does not lead to damage to the external sphincter. The efficacy of the method is 50-70%.
Patients with high-level RVF, recurrent disease course, pronounced cicatricial-fibrous changes of the rectovaginal septum, vaginal and rectal walls, post-radiation RVFs, as well as fistulas resulting from CD, are recommended Martius procedure (transposition of the bulbocavernosus muscle into the rectovaginal septum between the closed defects of the rectum and vagina) [10,49-52].
LoR CLoE 4Level of Recommendations — C (Level of Evidence — 4).
Comment: variants of the surgery include: transposition of a vascularized adipose tissue fragment from the labium majus or inguinal fold. Method is mainly used when fecal passage through the rectum is diverted. Cure of patients is noted in 65-100% of cases.
Patients with high-level RVF, recurrent disease course, the presence of pronounced cicatricial-fibrous changes of the rectovaginal septum, vaginal and rectal walls, post-radiation RVFs, as well as fistulas resulting from CD, are recommended gracilis muscle transposition into the rectovaginal septum between the closed defects of the rectum and vagina [53-58].
GCR BLOE 3Grade of Recommendation B (Level of Evidence - 3).
Comment: mainly used when fecal passage through the rectum is diverted. Cure of patients is recorded in 50-100% of cases.
Patients with RVF presenting with a high fistula tract location (middle and upper ampullary rectum), recurrent disease nature, large defects (greater than 2.5-3 cm), complex fistulas, pronounced cicatricial-fibrous changes of the rectovaginal septum, vaginal and rectal walls, as well as RVFs resulting from radiation therapy or CD, are recommended defect closure or resection of the bowel segment bearing the fistula opening via an abdominal (laparoscopic) approach [59,60,61].
LoR CLoE 4Level of Recommendations — C (Level of Evidence — 4).
Comment: the use of the method is recommended only in the presence of an intact proximal rectum and preserved anal sphincter function. The method is used with fecal diversion of the rectum. Cure of patients is noted in 75-100% of cases.
Patients with high-level RVF in the presence of a narrow fistula tract (up to 5 mm), location of the fistula opening no higher than 0.7 cm from the dentate line, and an intact rectal wall are recommended fistula elimination using a split vaginorectal flap [1,62,63].
LoR CLoE 4Level of Recommendations — C (Level of Evidence — 4).
Comment: the fistula is excised within healthy tissues. Then, the rectovaginal septum is split, and the posterior vaginal wall and anterior rectal wall are mobilized in a proximal direction from the wound. Next, a "bed" is formed to fix the lowered split flap in the vaginal vestibule and anal canal. The split rectovaginal septum is lowered as a "sleeve" and fixed to the anal sphincter, within the rectum and vagina. Healing occurs in 70% of cases.
A modification of the split vagino-rectal flap is the method of eliminating RVFs using mobilized lateral vaginal and rectal flaps [64]. A distinctive feature compared to the previous method is the formation of vaginal and rectal flaps from the wall segments of the vagina and rectum located laterally to the fistula opening. The absence of displacement of the proximal parts of both organs, along with the contralateral displacement of the formed flaps to reposition the suture lines in the vagina and rectum, leads to a reduced risk of postoperative complications. The prototype of this method is the treatment of rectal fistulas using a highly vascularized rectal flap [65].
In patients with RVFs presenting with pronounced scar-fibrous changes of the rectovaginal septum, vaginal and rectal walls, post-radiation RVFs, or large defects of the rectovaginal septum, it is recommended to perform fistula excision with separate closure of the vaginal and rectal wall defects [66].
LoR CLoE 4Level of Recommendations — C (Level of Evidence — 4).
Comment: numerous modifications of this method with various approaches have been proposed, but the conditions for surgical success are good mobilization of both organs for tension-free defect closure, as well as the displacement of the suture lines in the bowel and vagina relative to each other. The efficacy of the method ranges from 75 to 100%.
In patients with RVFs characterized by a high location of the fistulous tract, recurrent disease, large defects (greater than 1.6 cm), as well as impaired anal sphincter complex function (scar replacement of muscle structures or their absence along the anterior semicircle), it is recommended to eliminate the fistula by evagination of the rectal segment bearing the fistula opening, supplemented by sphincter-levatorplasty [67, 68].
LoR CLoE 4Level of Recommendations — C (Level of Evidence — 4).
Comment: following hydrodissection of the rectovaginal septum, the anatomical structures of the anal sphincter region, and the muscle structures of the levators, a circular dissection of the posterior vaginal wall and isolation of the fistulous tract down to the rectal wall are performed transvaginally around the rectovaginal septum defect. For complete evagination of the rectal wall segment bearing the fistula opening beyond the anal canal, thorough splitting of the rectovaginal septum is performed in all directions to a distance of at least 5 cm from the defect edges. The presence of a defect in the anal sphincter muscles is an essential condition for performing this operation, as it allows for the complete isolation of the rectal and anal canal walls in the distal direction almost to the perianal skin. After adequate mobilization of the anterior bowel wall segment, the anterior portions of the levator muscles and the ends of the external anal sphincter are visualized and isolated. Then, evagination ("turning inside out") of the bowel wall segment bearing the RVF is performed beyond the anal canal. Subsequently, sphincter-levatorplasty is performed with mandatory incorporation of uncompromised proximal sections of the rectal wall relative to the defect into the suture line. The efficacy of the method is 80%.
2.3 Minimally invasive surgical treatment of rectovaginal fistulas
Minimally invasive surgical treatments for RVFs include procedures that eliminate the fistula while keeping the intestinal wall intact and minimizing surgical trauma to the surrounding tissues.
In patients with uncomplicated RVFs and a narrow fistulous tract, it is recommended to use methods based on modern biological, biosynthetic, and synthetic materials [36, 44, 69-71].
LoR CLoE 4Level of Recommendations — C (Level of Evidence — 4).
Comment: the use of surgical biological glue and various types of implants is most effective in cases of long fistulous tracts, which is extremely rare in patients with rectovaginal fistulas, where most fistulas are essentially tubular. Given this, patient recovery after these techniques in RVF patients has been described in 14-40% of observations.
In patients with uncomplicated RVFs and a narrow fistulous tract, it is recommended to eliminate the fistula by laser thermal ablation of the fistulous tract combined with vaginal flapoplasty [72].
LoR CLoE 4Level of Recommendations — C (Level of Evidence — 4).
Comment: the method allows for the adequate elimination of RVFs while keeping the intestinal wall and surrounding perineal muscle structures intact, and performing tension-free vaginal plastic repair. The prototype of the proposed method is thermal ablation of the fistulous tract in the treatment of rectal fistulas [73]. This surgical correction of RVFs can be applied in the absence of inflammatory and scarring changes in the rectovaginal septum in the area of the fistulous tract, provided the diameter of the fistulous tract does not exceed 3 mm. A laser fiber is inserted into the fistulous tract via a vaginal approach. Laser thermal ablation of the fistula opening in the bowel, the part of the fistulous tract in the bowel wall, and the rectovaginal septum is performed. The fistula opening on the vaginal side is excised. The posterior vaginal wall is mobilized and fixed to the edges of the vaginal wound edge-to-edge without tension using interrupted sutures. The efficacy of the method reaches 50%.
In patients with uncomplicated RVFs and a narrow fistulous tract, it is recommended to eliminate the fistula by ligation of the fistulous tract and its transposition into the anal canal with the creation of an intestinal wall duplication [74].
LoR CLoE 4Level of Recommendations — C (Level of Evidence — 4).
Comment: the method is most effective for narrow, uncomplicated RVFs (lumen width no more than 4 mm). Using a transvaginal approach, the anterior rectal wall, the upper edge of the external and internal anal sphincters along the anterior semicircle, and the proximal third of the anal canal wall are mobilized; the fistulous tract is isolated up to the bowel wall without compromising its lumen integrity; the fistulous tract is ligated directly at the bowel wall and transected above the ligation zone; an intestinal wall duplication is created into which the ligated fistulous tract is embedded; and the created duplication zone is transposed in a distal direction beneath the internal sphincter into the proximal third of the anal canal. The efficacy of the method is noted in 50% of cases.
In patients with post-radiation RVFs, as well as fistulas resulting from Crohn's disease, microinjected autologous fat grafting (MAFG) is recommended [75-77].
GCR BLOE 3Grade of Recommendation B (Level of Evidence - 3).
Comment: purified adipose tissue is injected into the rectovaginal septum and the edges of the fistula from the vaginal side retrogradely in small quantities (1/5-1/10 ml) to ensure an even distribution of adipose tissue in the recipient zone. Complete recovery of patients can occur in 100% of cases.
2.4 The role of intestinal stoma in the treatment of rectovaginal fistulas
In RVFs, diversion of the intestinal contents away from the rectum is indicated in cases of severe inflammatory processes (infection of the vagina and urinary tract), rectovaginal septum defects greater than 3 cm, and high, complex, and post-radiation RVFs. A stoma can significantly improve the quality of life for patients in these situations. It should be noted that reliable data on the impact of fecal diversion on the surgical outcomes of RVF treatment are lacking. The decision to form a stoma in all patients with rectovaginal fistulas must be made on a strictly individual basis [20, 39, 78, 79].
4. Medical Rehabilitation and Sanatorium-Resort Treatment
The need for patient rehabilitation is due to surgical trauma to the perianal region, vagina, anal canal, and lower ampullary rectum, with postoperative sutures present in these anatomical areas. Secondary intention wound healing and sutures in the rectovaginal septum create a risk of pyogenic-septic complications and postoperative bleeding in the event of suture dehiscence. Pain syndrome of varying severity and potential disturbances in defecation and continence functions in the postoperative period can lead to significant social maladaptation and reduce the quality of life for this category of patients. General principles of rehabilitation after surgical treatment:
Comprehensive assessment of the patient's baseline condition and creation of a personalized rehabilitation program.
Drawing up a plan of diagnostic and therapeutic measures necessary for rehabilitation.
Multidisciplinary principle of organizing rehabilitation care.
Monitoring the effectiveness of the ongoing therapy during the course of restorative treatment and at the end of the rehabilitation program.
Stage 1 – early rehabilitation, from day 4 to day 10 after surgery. During this period, the patient stays in the inpatient rehabilitation unit for 5–7 days, after which further rehabilitation continues for 7–15 days in a short-stay day hospital or on an outpatient basis.
The most important objectives of the first stage of rehabilitation are the normalization of gastrointestinal function with the establishment of normal stool consistency and frequency. In addition, this stage involves monitoring hemostasis and the wound process, as well as managing postoperative pain.
Stage 2 (from day 15 to day 45 after surgery) is aimed at accelerating reparative processes and achieving geometrically correct, programmed healing of postoperative wounds while monitoring gastrointestinal function.
Following discharge from the hospital in the postoperative period, rehabilitation measures are necessary for all patients who have undergone surgical treatment for rectovaginal fistula (RVF). Depending on the severity of functional impairments, the complex of rehabilitation measures is carried out on an outpatient basis or in an inpatient setting.
All patients with RVF who experience defecation disorders (constipation) after surgical treatment are recommended mechanical bowel cleansing (performing a cleansing or siphon enema, prescribing osmotic laxatives with evaluation of their efficacy, mechanical removal of fecal masses under local or regional anesthesia) [1].
GCR CLOE 5Grade of Recommendation C (Level of Evidence - 5).
The goal of the 2nd stage of rehabilitation (which can be carried out on an outpatient basis or in a day hospital setting) for patients who have undergone surgical treatment for RVF is the complete epithelialization of postoperative wounds and the prevention of postoperative complications.
5. Prevention and Dispensary Observation
1. Prevention
Prevention of RVF consists of improving the quality of obstetric care, reducing the incidence of postpartum complications, and promptly involving a coloproctologist in cases of trauma to the rectum, the anal sphincter complex, and the anal canal. When obstetric complications arise, correct and timely treatment (suture of ruptures) and adequate postpartum and postoperative management are indicated.
Improving the quality of surgical care for patients with diseases of the anal canal and distal rectum:
correct choice of surgical treatment tactics;
correct technique for performing these interventions;
improving the quality of perioperative patient management;
early detection and correct management of patients with Crohn's disease;
proper selection of radiation therapy dosage in female patients with malignant pelvic diseases [22-24].
2. Follow-up
After completion of treatment and wound healing, follow-up examinations and assessments by a coloproctologist should be performed every 6 months during the first year.
6. Organization of Medical Care
1. Indications for hospitalization in a medical organization
1) Emergency hospitalization is indicated for RVF complicated by the formation of abscesses in the rectovaginal septum and pelvic fascial spaces (pelvirectal, ischioanal, subcutaneous, etc.).
2) Elective hospitalization is carried out to perform radical surgery.
Diagnostic procedures in an elective setting at the diagnostic stage can be performed on an outpatient basis. Surgical treatment is best performed in specialized inpatient coloproctology departments.
2. Indications for discharging a patient from a medical organization
1) In the case of emergency hospitalization for RVF complicated by abscess formation, indications for discharge are the resolution of acute disease manifestations, stabilization of the patient's condition, and adequate drainage of purulent cavities.
2) In the case of elective hospitalization for radical treatment of RVF, indications for discharge after elective surgery include: an uncomplicated course of the early postoperative period (absence of dysuria, increased bleeding, etc.); absence of purulent-septic complications of the wound process; the ability to achieve independent and full defecation after surgical treatment; the ability of patients (for patients with limited capabilities) to independently continue conservative therapy on an outpatient basis under the supervision of a regional coloproctologist.
7. Additional Information
Negative factors affecting treatment outcomes include:
Development of infectious complications.
Stool disorders (diarrhea or constipation).
Patient non-compliance with restrictions on motor activity and physical exertion.
Criteria for Evaluating the Quality of Medical Care
No. | Quality assessment criteria | Evaluation of compliance |
|---|---|---|
1. | All patients with RVF underwent an initial visit (examination, consultation) with a coloproctologist and/or an initial visit (examination, consultation) with an obstetrician-gynecologist, and/or an initial visit (examination, consultation) with a surgeon. | Yes/No |
2. | Transrectal ultrasound of the rectum and/or pelvic magnetic resonance imaging with intravenous contrast was performed. | Yes/No |
3. | An examination of the sphincter apparatus of the rectum was performed (in the presence of signs of anal sphincter insufficiency). | Yes/No |
4. | Fistula excision into the bowel lumen was performed in patients with low-level RVF. | Yes/No |
5. | Fistula excision and sphincteroplasty (for concomitant anal sphincter insufficiency caused by an anal sphincter defect or scar substitution of muscle tissue along the anterior semicircle) were performed in patients with low-level RVF. | |
6. | Fistula elimination using the "invagination method" (with a fistula opening diameter of at least 7 mm and not more than 12 mm) was performed in patients with high-level RVF. | Yes/No |
7. | Segmental proctoplasty was performed in patients with high-level RVF when the fistula opening was localized no higher than 1 cm from the dentate line and with preserved anal sphincter function. | Yes/No |
8. | Martius procedure was performed in patients with high-level RVF, recurrent disease course, and/or post-radiation RVF, and/or fistulas resulting from Crohn's disease. | Yes/No |
9. | Transposition of the gracilis muscle into the rectovaginal septum between the sutured defects of the rectum and vagina was performed in patients with high-level RVF, recurrent disease course, and/or post-radiation RVF, and/or fistulas resulting from Crohn's disease. | Yes/No |
10. | Suture of the defect or resection of the bowel segment bearing the fistula opening via an abdominal (laparoscopic) approach was performed in patients with high-level RVF, recurrent disease course, and/or large defects (more than 2.5–3 cm), and/or post-radiation RVF, and/or fistulas resulting from Crohn's disease. | Yes/No |
11. | Fistula elimination using a split vaginorectal flap was performed in patients with high-level RVF in the presence of a narrow fistula tract (up to 5 mm) and location of the fistula opening no higher than 0.7 cm from the dentate line. | Yes/No |
12. | Fistula excision with separate closure of the vaginal and rectal wall defects was performed in patients with high-level RVF who had pronounced scar-fibrous changes of the rectovaginal septum, vaginal walls, and rectum, and/or post-radiation RVF, and/or large rectovaginal septum defects. | Yes/No |
13. | Fistula elimination using the invagination method supplemented by sphincterolevatoplasty was performed in patients with RVF with a high location of the fistula tract and/or recurrent disease course and/or large defects (greater than 1.6 cm) and impaired anal sphincter complex function (scar substitution of muscle structures or their absence along the anterior semicircle). | Yes/No |
14. | The use of biological and/or biosynthetic and/or synthetic materials was performed in patients with RVF with an uncomplicated disease course and the presence of a narrow fistula tract. | Yes/No |
15. | Fistula elimination by laser thermal ablation of the fistula tract with vaginal flap plastic repair was performed in patients with RVF with an uncomplicated disease course and the presence of a narrow fistula tract. | Yes/No |
16. | Fistula elimination by ligation of the fistula tract and its transposition into the anal canal with the creation of a duplication of the intestinal wall was performed in patients with an uncomplicated disease course and the presence of a narrow fistula tract. | Yes/No |
17. | Micro-injection autologous fat transplantation was performed in patients with post-radiation RVF and/or fistulas resulting from Crohn's disease. | Yes/No |
References
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Appendix A1. Working Group Composition
№ | Full name | Academic degree | Academic title | Professional association |
|---|---|---|---|---|
1. | Adamyan Leila Vladimirovna | D.Sc. in Medicine | Academician of the RAS, Professor | Russian Society of Obstetricians and Gynecologists |
2. | Sergey I. Achkasov | Dr. Sc. Med. | Corresponding Member of the Russian Academy of Sciences, Professor | Association of Coloproctologists of Russia |
3. | Oleg M. Biryukov | Ph.D. in Medicine | Association of Coloproctologists of Russia | |
4. | Leonid A. Blagodarny | D.Sc. in Medicine | Professor | Association of Coloproctologists of Russia |
5. | Vitaly S. Groshilin | D.Sc. in Medicine | Professor | Association of Coloproctologists of Russia |
6. | Ilkanich Andrey Yanoshevich | D.Sc. in Medicine | Professor | Association of Coloproctologists of Russia |
7. | Kashnikov Vladimir Nikolayevich | D.Sc. in Medicine | Associate Professor | Association of Coloproctologists of Russia |
8. | Korotkikh Nikolai Nikolaevich | D.Sc. in Medicine | Association of Coloproctologists of Russia | |
9. | Ivan V. Kostarev | D.Sc. in Medicine | Associate Professor | Association of Coloproctologists of Russia |
10. | Kuzminov Aleksandr Mikhailovich | D.Sc. in Medicine | Professor | Association of Coloproctologists of Russia |
11. | Aleksey I. Moskalev | Ph.D. in Medicine | Association of Coloproctologists of Russia | |
12. | Andrey A. Mudrov | D.Sc. in Medicine | Associate Professor | Association of Coloproctologists of Russia |
13. | Omarova Mariiam Magomedovna | Ph.D. in Medicine | Association of Coloproctologists of Russia | |
14. | Popov Dmitry Evgenievich | Ph.D. in Medicine | Associate Professor | Association of Coloproctologists of Russia |
15. | Teryushkova Zhanna Ivanovna | D.Sc. in Medicine | Association of Coloproctologists of Russia | |
16. | Titov Alexander Yuryevich | D.Sc. in Medicine | Association of Coloproctologists of Russia | |
17. | Frolov Sergey Alekseevich | D.Sc. in Medicine | Professor | Association of Coloproctologists of Russia |
18. | Khitaryan Alexander Georgievich | D.Sc. in Medicine | Professor | Association of Coloproctologists of Russia |
19. | Shelygin Yury Anatolyevich | D.Sc. in Medicine | Academician of the RAS, Professor | Association of Coloproctologists of Russia |
Most members of the working group are members of the Association of Coloproctologists of Russia. There is no conflict of interest.
Appendix A2. Methodology for Developing Clinical Guidelines
Target audience of the clinical guidelines:
Coloproctologists
Surgeons
Gastroenterologists
Internists
General practitioners (family physicians)
Endoscopists
Nursing staff
Medical students, residents, postgraduate students.
Table 1. Rating scale for levels of evidence (LoE) for diagnostic methods (diagnostic interventions).
LoE | Definition |
|---|---|
1 | Systematic reviews of studies with reference standard control or systematic reviews of randomized controlled trials with meta-analysis |
2 | Individual studies with reference standard control or individual randomized controlled trials and systematic reviews of studies of any design, except randomized controlled trials, with meta-analysis |
3 | Studies without consecutive reference standard control or studies with a reference standard not independent of the test method, or non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case report |
5 | Only justification of mechanism of action or expert opinion is available |
Table 2. Rating scale for levels of evidence (LoE) for prevention and treatment methods (preventive, therapeutic, and rehabilitation interventions).
LoE | Definition |
|---|---|
1 | Systematic review of RCTs (randomized controlled trials) with meta-analysis |
2 | Individual RCTs and systematic reviews of studies of any design except RCTs, with meta-analysis |
3 | Non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case reports or case series, case-control studies |
5 | Only justification of the mechanism of action of the intervention (preclinical studies) or expert opinion is available |
Table 3. Rating scale for grades of recommendation (GoR) for methods of prevention, diagnosis, treatment, and medical rehabilitation, including those based on natural therapeutic factors (preventive, diagnostic, therapeutic, and rehabilitation interventions).
GoR | Definition |
|---|---|
A | Strong recommendation (all considered efficacy criteria (outcomes) are important, all studies are of high or acceptable methodological quality, and their conclusions on the outcomes of interest are consistent) |
B | Conditional recommendation (not all considered efficacy criteria (outcomes) are important, not all studies are of high or acceptable methodological quality, and/or their conclusions on the outcomes of interest are inconsistent) |
C | Weak recommendation (lack of adequate quality evidence (all considered efficacy criteria (outcomes) are unimportant, all studies are of low methodological quality, and their conclusions on the outcomes of interest are inconsistent) |
Procedure for updating clinical guidelines.
The mechanism for updating the clinical guidelines provides for their systematic revision—at least once every three years, as well as upon the emergence of new evidence-based medicine data regarding the diagnosis, treatment, prevention, and rehabilitation of specific diseases, or the presence of justified additions/comments to previously approved clinical guidelines, but no more than once every 6 months.
Appendix A3. Reference Materials
These clinical guidelines were developed taking into account the following regulatory legal documents:
Federal Law No. 323-FZ dated November 21, 2011 (as amended on December 24, 2024) "On the Fundamentals of Protecting Citizens' Health in the Russian Federation"
Decree of the Government of the Russian Federation No. 1968 of November 17, 2021, "On Approval of the Rules for the Phased Transition of Medical Organizations to the Provision of Medical Care Based on Clinical Guidelines Developed and Approved in Accordance with Parts 3, 4, 6–9, and 11 of Article 37 of the Federal Law 'On the Fundamentals of Protecting the Health of Citizens in the Russian Federation'"
Order of the Ministry of Health of the Russian Federation No. 206n of April 2, 2010 (as amended on February 21, 2020) "On Approval of the Procedure for Providing Medical Care to the Population with Colorectal, Anal Canal, and Perineal Diseases in Coloproctology"
Order of the Ministry of Health of the Russian Federation No. 168n of March 15, 2022, "On Approval of the Procedure for Dispensary Observation of Adults"
Order of the Ministry of Health of the Russian Federation No. 1363n of December 23, 2020, "On Approval of the Procedure for Referring Insured Persons to Medical Organizations, the Functions and Powers of Founders in Respect of Which Are Exercised by the Government of the Russian Federation or Federal Executive Bodies, to Provide Medical Care in Accordance with the Unified Requirements of the Basic Compulsory Medical Insurance Program"
Appendix B. Physician Action Algorithms
Appendix C. Patient Information
Disease information.
A rectovaginal fistula is an abnormal tract that does not normally exist, connecting the lumen of the rectum and the vagina.
Etiology and pathogenesis: the condition is most often acquired, and much less frequently congenital. Congenital rectovaginal fistulas are generally treated in childhood. The most frequent causes of acquired rectovaginal fistulas are:
complicated labor (prolonged labor, perineal tears);
injury to the rectal wall during various pelvic surgeries (gynecological, proctological operations);
traumatic injuries of the septum separating the rectum and vagina (rectovaginal septum);
spontaneous rupture of acute paraproctitis into the vaginal lumen;
complications of inflammatory bowel disease (Crohn's disease).
Since the anterior wall of the rectum directly abuts the vaginal wall along its entire length, any damage to the septum between them (the rectovaginal septum) leads to prolapse of the rectal mucosa into the vaginal lumen. This occurs because the pressure in the rectum significantly exceeds the pressure in the vagina. Within 7-8 days, the prolapsed rectal mucosa adheres to the vaginal walls, forming a permanent pathological communication between these two organs: a rectovaginal fistula.
Clinical presentation: the most characteristic complaint is the passage of gas and stool from the vagina. Patients also frequently complain of purulent vaginal discharge, perineal pain, recurrent urinary and genital tract infections, and difficulty or inability to engage in sexual intercourse. These symptoms create insurmountable barriers to intimate life and may threaten the stability of a marriage or prevent one from forming.
Treatment: diagnosis and treatment of rectovaginal fistulas are best performed in specialized coloproctology departments. Surgery is the only method for radical cure. Depending on the complexity and location of the fistula, various surgical interventions are performed. High rectovaginal fistulas often require an abdominal approach. Treatment may be multi-staged, with one of the stages being the creation of an artificial anus (colostomy) on the anterior abdominal wall.
Prognosis: overall, the prognosis is favorable. Specialized departments achieve a cure rate of over 96% of female patients.
Information required in the postoperative period. In the postoperative period, during the first 1-3 months after surgery, hygiene measures and regulation of stool frequency and consistency are essential. It is necessary to achieve a regular, daily, soft-consistency stool that does not traumatize the wound surfaces in the anal canal and rectum.
If difficulty in rectal evacuation or constipation develops, stool normalization must be achieved. Treatment of constipation, unless caused by conditions requiring surgery, should begin with a diet containing sufficient amounts of plant fiber, fermented dairy products, and vegetable oil. Smoked foods, pickled foods, marinades, cocoa, and chocolate are excluded from the diet, and fried dishes, sausage products, and rye bread are partially restricted. Try to eat less bread and bakery products made from premium wheat flour (especially fresh and soft ones), pasta, and semolina dishes. Foods with a high content of fiber and ballast substances (found in plant-based foods, primarily grains) are recommended. Foods that contribute to stool normalization include: fresh kefir, prostokvasha (fermented milk), and acidophilus milk. Prunes and figs soaked in water, infusions made from them, plum juice, boiled beets, and dried fruit puree have a positive effect. Soups and cabbage soups based on strong vegetable broth are beneficial as first courses.
Dietitians recommend a pudding made of carrots, prunes, and apples with added lemon, beetroot puree, and vinaigrette salad with vegetable oil. In the morning on an empty stomach, drinking a glass of mineral water, fruit juice (plum, peach, apricot), or a hot lemon drink is recommended. A laxative effect is produced by eating grated carrot, a raw apple, kefir, or 5-7 prunes washed and soaked in boiling water overnight on an empty stomach. In addition, if the general condition is satisfactory, walks and mild physical activity are indicated. Morning exercise, physical exercises focusing on the abdominal muscles, and brisk walking are recommended.
Pharmacotherapy for constipation should be carried out with great caution, in short courses, under medical supervision.
A few additional recommendations for constipation:
Consult your doctor to find out which of the above recommendations are suitable for you.
Drink 4-8 glasses of fluid per day.
Your diet should include foods that promote bowel movement (peristalsis). We recommend whole-grain bread, bran crispbreads, porridges—buckwheat, oatmeal, wheat, or pearl barley with milk or vegetable oil—and grain dishes. Include fiber-rich foods in your diet (dietitians recommend adding raw vegetables and fruits, nuts, and sprouted wheat to milkshakes, for example). Try oatmeal cookies and cornflakes.
Apples, figs, dates, and tea with lemon help some patients well.
Prune decoction is useful in the mornings and at night.
Be sure to add bran to your food, starting with one teaspoon per day. Then this amount should be increased to 4-6 tablespoons per day. Too rapid a dose increase can cause loose stools and abdominal bloating. Try adding bran to porridges, rice or potato casseroles, and dairy products.
During antitumor drug therapy, use laxatives only as a last resort.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
Russian name: numerological rating scale (NRS).
Original name (if applicable): the Numeric Pain Rating Scale (NPRS).
Source (official developer website, publication with validation): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2647033/pdf/main.pdf, https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1038/clpt.1983.159?sid=nlm%3Apubmed
Type: rating scale.
Purpose: the scale is designed to determine pain intensity, allowing an assessment of subjective pain sensations experienced by the patient at the time of examination.
Content (template):
Key (interpretation): according to the recommendations.
Explanation: This method of subjective pain assessment involves asking the patient to mark a point on a 10 cm graduated line that corresponds to the severity of the pain. The left border of the line corresponds to the definition of "no pain".