List of Abbreviations
EKKh – epithelial coccygeal tract
MRI – magnetic resonance imaging
US – ultrasound examination
PEL – pelvic organs
ICD-10 – International Classification of Diseases 10th Revision
RCT – randomized controlled trial
LCE – level of confidence of evidence
GRS – grade of recommendation strength
Terms and Definitions
Primary fistula opening – epithelial invagination in the form of a narrow tract located along the midline in the intergluteal cleft.
Secondary fistula opening – an opening arising as a result of inflammatory changes in the epithelial coccygeal tract and surrounding tissue, often opening quite far from the sacrococcygeal region (gluteal region, perineum).
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Epithelial coccygeal tract (pilonidal cyst, pilonidal sinus) is a narrow tract lined with epithelium, containing hair follicles, sebaceous glands, and opening on the skin of the sacrococcygeal region and intergluteal cleft via primary and secondary fistula openings [1, 2].
Epidermal cyst - a benign epithelial lesion representing a closed cavity lined with epidermis and filled with keratin masses and cholesterol [3].
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
There are several theories regarding the development of the epithelial coccygeal tract.
In Russian literature, it is generally accepted that the epithelial coccygeal tract is a congenital disease caused by a defect in the caudal part of the embryo, resulting in the formation of a tract beneath the skin of the intergluteal cleft. Inflammation most commonly develops with the onset of puberty. During this period, hairs begin to grow within the lumen of the tract, and products of sweat and sebaceous gland activity accumulate. The proximity of the anus causes an abundance of microflora on the skin of the sacrococcygeal region, which in turn leads to the development of inflammation [1].
Some foreign specialists consider pilonidal disease to be an acquired condition caused by trauma to the sacrococcygeal region, abnormal hair growth, abundant hair coverage, and a deep intergluteal cleft, which leads to hair ingrowth into the skin and cyst formation. Obstruction of hair follicles leads to enlargement and rupture of the sebaceous glands, resulting in abscess formation or chronic inflammation of the epithelial coccygeal tract [4-7].
Due to the continuous exposure to pathogenic microorganisms, newly formed abscesses may recur, typically over many years. Thus, the recurrence rate has become an important parameter for evaluating treatment efficacy [6-8].
1.3 Epidemiology of the Disease or Condition
According to various literature data, the incidence of the epithelial coccygeal tract is 26-48 per 100,000 population. Clinical manifestations are detected in the most socially active category of patients, predominantly aged 15 to 30 years. This disease is more common in individuals with abundant hair coverage [4-11].
1.4 Features of Coding the Disease or Condition
ICD-10 Codes
Class - Diseases of the skin and subcutaneous tissue (XII):
L05 Pilonidal cyst
L05.0 Pilonidal cyst with abscess
L05.9 Pilonidal cyst without abscess
L72.0 Epidermal cyst
1.5 Classification of the disease or condition
Pilonidal disease or epithelial coccygeal tract is the standard term for the entire spectrum of pathologies, ranging from relatively asymptomatic, simple defects to complex chronically inflamed cavities with multiple fistulous tracts. Different stages of the disease may require specific treatment strategies.
The difficulty in choosing treatment tactics is largely due to the lack of a universally accepted classification. With the same pathological process referred to by different names, various surgical interventions are performed. This makes it difficult to evaluate treatment outcomes and determine the most appropriate surgical approach at different stages of the same disease. Furthermore, this entails not always justified surgical actions for various manifestations of this disease [12].
Several classification systems have been proposed in recent years. Currently, the most comprehensive is the classification developed by the State Research Center of Coloproctology named after A.N. Ryzhikh of the Russian Ministry of Health [1]:
1. Uncomplicated epithelial coccygeal tract (without clinical manifestations)
2. Acute inflammation of the epithelial coccygeal tract:
infiltrative stage
abscess formation
3. Chronic inflammation of the epithelial coccygeal tract:
infiltrative stage
recurrent abscess
purulent fistula
4. Remission of inflammation of the epithelial coccygeal tract
1.6 Clinical presentation of the disease or condition
A pathognomonic sign of the epithelial coccygeal tract is the presence of one or more primary openings in the midline of the intergluteal cleft. The openings are more difficult to detect in the presence of an abscess in the sacrococcygeal region, but they are clearly visualized two to three weeks after its opening.
Prior to the onset of the inflammatory process, there are no clinical manifestations of the epithelial coccygeal tract. When acute inflammation develops, the classical picture presents with typical features: pain, edema, hyperemia, and, depending on the extent and severity of the acute inflammatory process, fever.
After opening an abscess, the disease may transition into a chronic form with the formation of fistulas, cavities, and extensions in the sacrococcygeal and adjacent regions: lumbar, gluteal, ischioanal, ischiorectal, scrotal, and even femoral. In the absence of treatment, given the difficulty of access to this area for the patient, the chronic inflammatory process can persist for a long time and lead to extensive cicatricial and inflammatory changes.
2. Diagnostics, medical indications and contraindications for diagnostic methods
The diagnosis of the epithelial coccygeal tract is established based on physical examination and instrumental investigation data.
At the same time, differential diagnosis must be performed with a number of other diseases [1, 2, 4, 13, 14]:
furuncle and carbuncle, hidradenitis suppurativa;
acute and chronic paraproctitis;
presacral cyst and soft tissue cysts;
meningocele;
lipoma;
atheroma;
osteomyelitis of the sacrum and coccyx.
Principles of formulation of the diagnosis.
When formulating the diagnosis of the epithelial coccygeal tract, the nature of the disease course should be reflected. Examples of diagnosis formulations are given below:
"Acute inflammation of the epithelial coccygeal tract."
"Acute inflammation of the epithelial coccygeal tract with extension (abscess) formation in the left ischiorectal fat."
"Chronic inflammation of the epithelial coccygeal tract with the formation of secondary fistula openings in the right gluteal region."
2.1 Complaints and Anamnesis
The main clinical manifestations of epithelial coccygeal tract inflammation are:
Pain in the sacrococcygeal region.
Discharge of pus and serosanguinous fluid.
Elevated body temperature and fever.
Considering the two main forms of the disease - acute and chronic, the clinical manifestations of each are specific.
Thus, acute inflammation corresponds to all signs of a local inflammatory response - infiltrate, hyperemia, pain, abundant purulent discharge, and elevated body temperature.
Chronic inflammation is characterized by discomfort, discharge (less abundant, insignificant) of mucus and pus, maceration, pruritus, and the presence of primary and secondary openings of the epithelial coccygeal tract [1, 2, 4].
During exacerbation of the chronic inflammatory process, patients complain of pain in the sacrococcygeal region, discharge of purulent and serosanguinous fluid from the primary and secondary openings, elevated body temperature, and discomfort [1, 2, 4, 15].
When taking the medical history of patients with an epithelial coccygeal tract, etiological factors of the disease (trauma to the sacrococcygeal region, overweight, hyperhidrosis, sedentary lifestyle) should be considered, and attention should be paid to the duration and nature of complaints in order to early identify risk factors, prognostic signs, and optimize patient management tactics [1, 2, 16].
Symptoms depend on the form of the epithelial coccygeal tract. The uncomplicated (asymptomatic) form is characterized by one or more primary openings and is detected only as an incidental finding. Pilonidal abscess manifests as edema and pain in the sacrococcygeal region. Chronic inflammation presents with continuous or intermittent serous or purulent discharge from the primary/secondary openings.
2.2 Physical Examination
Patients with suspected epithelial coccygeal tract are recommended to undergo an initial appointment (examination, consultation) with a primary coloproctologist (or primary surgeon) with a mandatory physical examination to determine the extent of the purulent-inflammatory process [1, 2, 43].
GCP CLEL 5Grade of Recommendation – C (Level of Evidence – 5).
Comment: physical examination includes:
external inspection of the sacrococcygeal region;
external inspection of the perineal and anal regions;
transrectal digital examination of the rectum.
The examination should be performed with the patient lying on their abdomen or in the knee-chest position. The number and location of primary/secondary openings, the state of the skin of the sacrococcygeal region, perianal region, and buttocks (hyperemia and edema) are assessed. Palpation of the intergluteal cleft area reveals the presence of scarring and inflammatory processes. A transrectal digital examination of the rectum is also mandatory to rule out any connection between the inflammatory process and the rectum or the presence of an infiltrate (abscess) in the ischioanal or ischiorectal space, and in women, a bimanual vaginal examination. In children under 18 years of age, the rectal examination is performed in compliance with the requirements for a gynecological examination [41, 42].
2.3 Laboratory Diagnostics
There are no specific laboratory tests for diagnosing the epithelial coccygeal tract.
2.4 Instrumental Diagnostics
When the inflammatory process is localized to the sacrococcygeal region, a clinical examination is sufficient in most cases. However, for widespread and recurrent forms of the disease, it is advisable to use various instrumental diagnostic methods, including for differential diagnosis.
Patients with pilonidal sinus disease are recommended to undergo an ultrasound examination of the soft tissues (one anatomical zone) of the sacrococcygeal region; if involvement of the pelvic cellular spaces is suspected, a transrectal ultrasound of the rectum is indicated [17, 18, 43].
Level of Evidence (LoE) 4Grade of Recommendation (adults) – C (Level of Evidence – 4).
Level of Evidence (LoE) 5Grade of Recommendation (children) – C (Level of Evidence – 5).
Comment: ultrasound allows determining the extent of the sinus tract, its localization, dimensions, structure of the pathological focus, additional tracts, and the degree of involvement of surrounding tissues [17, 18, 19].
In adults and adolescents over 16 years of age with pilonidal sinus disease, when the spread of the inflammatory process to the pelvic cellular spaces is suspected, or for differential diagnosis with pelvic diseases (presacral cysts, teratomas), as well as with pelvic and spinal bones (meningocele, osteomyelitis), MRI of the pelvic organs is recommended [45, 46].
Level of Evidence CGrade of Recommendation 4Level of Evidence – C (Grade of Recommendation – 4).
2.5 Other Procedures
None.
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
3.1 Conservative therapy, diet therapy, analgesia
None.
3.2 Surgical treatment of acute inflammation of the pilonidal sinus
Patients with acute pilonidal inflammation and a sacrococcygeal abscess are recommended to undergo incision and drainage of the phlegmon (abscess) as primary treatment [19, 20].
Level of Evidence (LoE) 4Grade of Recommendation (adults) – C (Level of Evidence – 4).
Level of Evidence (LoE) 5Grade of Recommendation (children) – C (Level of Evidence – 5).
Comment: the abscess cavity is punctured at the point of greatest fluctuation, and the liquid contents are aspirated with a syringe and sent to a microbiological laboratory for microbiological (culture) examination of the purulent discharge for aerobic and facultatively anaerobic microorganisms, as well as rapid determination of antibiotic sensitivity of endotoxins in the purulent discharge [21]. Then, the abscess cavity is opened with a longitudinal incision. Surgical debridement of the wound to remove necrotic or infected tissue reduces wound healing time. Within unchanged tissues, sparing excision of the pilonidal sinus tract and its ramifications, as well as the surrounding adipose tissue, is performed; the wound is managed openly during these operations. The long-term recurrence rate with open wound management is 28%–78.8% [21, 22, 23]. Definitive treatment should be performed after regression of local inflammation (usually no earlier than 5–7 days).
In children with acute pilonidal inflammation, treatment should be limited to abscess incision and wound curettage without excision of the pilonidal sinus tract and its ramifications. After the inflammation subsides, radical treatment should be performed no earlier than 1 month later [41, 43].
3.3 Minimally invasive treatment of the pilonidal sinus
Adult patients with chronic pilonidal inflammation are not recommended to receive fibrin glue (embolic glue) [26].
Level of Evidence (LoE) 1Grade of Recommendation (adults) – A (Level of Evidence – 1).
Comment: currently, the efficacy of fibrin glue (embolic glue) as monotherapy or as an adjunct to surgical intervention is undefined due to the low level of evidence. The results of conducted studies had a risk of bias and included a small number of participants [26].
Patients with chronic pilonidal inflammation (straight tract, no purulent extensions or severe inflammatory tissue infiltration) are recommended to undergo endoscopic pilonidal sinus ablation [27, 48].
Grade of Recommendation (GoR) BLevel of Evidence (LoE) 2Grade of Recommendation – B (Level of Evidence – 2) – for adults.
Grade of Recommendation (GoR) CLevel of Evidence (LoE) 4Grade of Recommendation – C (Level of Evidence – 4) – for children.
Comment: the efficacy of the method is 93%, and the recurrence rate is 6.3%. Complications (hematoma, long-healing wounds, etc.) occur in 1.1% of observations [27].
For patients with uncomplicated chronic inflammation of the epithelial coccygeal passage (straight tract, without purulent extensions and marked inflammatory tissue infiltration), laser thermal ablation is recommended [28, 48].
GOM CLOE 4Level of Evidence – C (Level of Data Reliability – 4).
Comment: laser thermal ablation can be repeated if the first procedure is ineffective. The efficacy of the method after a single session is 80 - 90%. The recurrence rate ranges from 15.2% to 36.6% [23, 28].
For patients with chronic inflammation of the epithelial coccygeal passage at the stage of a purulent fistula, or in remission of inflammation (straight tract, without purulent extensions and marked inflammatory tissue infiltration), subcutaneous excision of the epithelial coccygeal passage (sinusectomy) is recommended [29, 30].
CGR BLEL 1Level of recommendation grade – B (level of evidence – 1).
Comment: absolute contraindications for this procedure include: presence of tract ramifications, purulent extensions and cavities, and a significant distance between the primary and secondary openings. The epithelial coccygeal passage is stained with methylene blue through the primary or secondary fistulous opening. The coccygeal tract is excised subcutaneously from the primary opening to the secondary ones. Next, a probe with a button end is passed through the openings of the tract, and the tract is excised along the probe using electrocoagulation. The resulting wounds are left unstitched. The efficacy of the method is 83.8 - 94.0%. The recurrence rate ranges from 5.8% to 16.2% [23, 29-31].
3.4 Surgical treatment of chronic pilonidal sinus
The primary treatment method for pilonidal disease is surgical. Surgical treatment implies the elimination of the source of inflammation, specifically the coccygeal tract along with all primary openings, inflamed surrounding tissues, and secondary fistulous openings [1, 2, 10]. The type of surgical intervention depends on the extent of the inflammatory process.
In adolescents with prominent body hair, hair removal in the intervention area is recommended prior to surgical treatment, ensuring the absence of hair cover for at least 2 weeks after surgery [43].
GCP CLEL 5Grade of Recommendation – C (Level of Evidence – 5).
For patients with chronic inflammation of the epithelial coccygeal passage (tortuous tract, with extensions, secondary openings), excision of the epithelial coccygeal passage without wound closure is recommended [23, 29, 32].
ROB BLOE 1Recommendation grade – B (evidence level – 1).
Comment: within healthy tissue boundaries, conservative excision of the coccygeal tract and its ramifications, as well as the surrounding adipose tissue, is performed; the wound in these surgeries is managed by open technique in adult patients [23, 32].
For pediatric patients with chronic inflammation of the epithelial coccygeal passage (tortuous tract, with extensions, secondary openings), excision of the epithelial coccygeal passage with wound closure is recommended [41, 42].
GCP CLEL 5Grade of Recommendation – C (Level of Evidence – 5).
For patients with chronic inflammation of the epithelial coccygeal passage (tortuous tract, with extensions, secondary openings), excision of the epithelial coccygeal passage with partial wound closure (suturing wound edges to the wound base) is recommended [23, 33].
GOR BLOE 2Grade of Recommendation – B (Level of Evidence – 2).
Comment: using a scalpel or electrosurgical knife, the tracts are excised en bloc with the skin of the intergluteal cleft, including all opening orifices and subcutaneous tissue containing the tracts, down to the fascia of the sacrum and coccyx via two encompassing incisions. Next, the posterior wall of the tract and partially the upper parts of the lateral walls are excised, after which the skin edges of the incision are sutured to the fascia of the sacrum and coccyx in a staggered («checkerboard») pattern. Sutures are removed on days 10-12. The recurrence rate is 14.3-16.3% [23].
For patients with chronic inflammation of the epithelial coccygeal passage, excision of the tract with primary tight wound closure is not recommended. Midline closure is ineffective in adult patients due to the high disease recurrence rate [9, 23].
GCP BLoE 2Grade of Recommendation – B (Level of Evidence – 2).
Comment: excision of the coccygeal tract and its ramifications is performed within healthy tissue boundaries. When wounds are closed along the midline, the disease recurrence rate remains high, ranging from 16.8% to 67.9% according to literature data, depending on the follow-up duration [9, 23].
For patients with recurrent or advanced forms of epithelial coccygeal passage disease with multiple extensions into the right and left gluteal regions, asymmetric plastic surgeries aimed at eliminating extensive tissue defects are recommended [34, 49].
LGR 1Level of Recommendation Strength (adults) – A (Level of Evidence – 1).
LGR 4Level of Recommendation Strength (children) – C (Level of Evidence – 4).
Comment: among the multitude of plastic surgery methods for tissue defect closure following excision of the epithelial coccygeal passage, the Karydakis procedure, Bascom procedure, Limberg flap, and their numerous modifications (L-, Z-, Y-, W-plasty) are the most widespread.
The advantage of these techniques is the reduction of the wound defect, which contributes to rapid healing and a good cosmetic outcome. The efficacy is 85–90%. The recurrence rate with the Karydakis and Bascom procedures is 6.2–10.2% [34]. The recurrence rate when performing Limberg flap procedures (L-, Z-, Y-, W-plasty) ranges from 6.4 to 11.4 according to various sources [23, 34]. In the adolescent population, the use of asymmetric fasciocutaneous flaps has shown good results: shorter healing times, improved cosmetic outcome, and a lower recurrence rate (4% vs 28.6% with conventional excision) [49].
4. Medical Rehabilitation and Sanatorium-Resort Treatment
All patients who have undergone surgical treatment for pilonidal sinus disease in the postoperative period until wound healing are recommended to have daily dressings applied with a sterile bandage in case of purulent skin and subcutaneous tissue diseases (to reduce the risk of inflammatory complications) [1, 2, 50].
GCP CLEL 5Grade of Recommendation – C (Level of Evidence – 5).
All patients who have undergone surgical treatment for pilonidal sinus disease are recommended to have follow-up care after discharge from the hospital during the wound healing period in the form of an appointment (examination, consultation) with a coloproctologist or surgeon at their place of residence for the purpose of preventing recurrences and complications of the disease [1, 2, 51].
Level of Evidence CGrade of Recommendation 4Level of Evidence – C (Grade of Recommendation – 4).
Comment: the presence of postoperative wounds in the specified anatomical regions and their healing by secondary intention entail a risk of purulent-septic complications and postoperative bleeding.
General principles of rehabilitation after surgical treatment:
1) comprehensive assessment of the patient's baseline condition and formulation of a rehabilitation program;
2) drawing up a plan of diagnostic and therapeutic measures necessary for rehabilitation;
3) multidisciplinary approach to the organization of rehabilitation care;
4) monitoring the effectiveness of therapy during restorative treatment and at the end of the rehabilitation course.
Stages of patient rehabilitation after surgical treatment:
Stage 1 - early rehabilitation, from days 4–6 to days 7–10 after surgery. During this period, the patient undergoes inpatient rehabilitation for 3–5 days, after which further rehabilitation continues for 7–14 days in an outpatient setting or day hospital.
Control of hemostasis, use of hemostatic therapy, electrocoagulation of bleeding surfaces.
Pain management: the severity of pain depends on the extent of surgical trauma and the individual pain threshold. Analgesia is performed using systemic and/or local agents, which are selected by the attending physician individually depending on the severity of pain, the extent of surgical trauma, and the psycho-emotional state of the patient.
Programmed wound healing process: one of the most important aspects of postoperative patient recovery, allowing to avoid the development of postoperative complications, is timely and topographically precise healing of postoperative wounds. Proper management of the wound healing process from the 2nd day after surgery until complete epithelialization of the wounds implies: daily sanitization of wounds with antiseptic solutions (D08A Antiseptics and disinfectants), dressing with ointment applications (the composition of the ointment is determined by the stage of the wound healing process); dynamic monitoring by a coloproctologist (examination of the sacrococcygeal region); microbiological (culture) examination of the discharge for aerobic and facultatively anaerobic microorganisms (if purulent-septic complications and wound infection are suspected) [52, 53, 55].
The goal of stage 2 of rehabilitation for patients who have undergone surgical treatment for pilonidal sinus disease is the complete epithelialization of postoperative wounds and the prevention of postoperative complications.
Patients after surgical treatment, in order to improve wound healing and reduce the rate of postoperative complications, are recommended to undergo vacuum application (negative pressure wound therapy, vacuum therapy) [35, 36, 37].
GCP CLEL 3Grade of Recommendation – C (Level of Evidence – 3).
Comment: the use of vacuum therapy aims to accelerate the regeneration process through the local application of reduced pressure. Negative pressure mechanically approximates and stabilizes wound edges, reduces the wound defect, lowers the bacterial load on the wound surface, and also prevents wound desiccation [35, 36, 37].
Patients after surgical treatment, in order to improve wound healing and reduce the rate of postoperative complications, are recommended to undergo sessions of low-level laser irradiation on the postoperative wound area [54].
GCP CLEL 5Grade of Recommendation – C (Level of Evidence – 5).
Comment: the use of laser therapy helps to stimulate reparative processes, shorten healing times, reduce bacterial contamination of postoperative wounds, and decrease pain intensity [38, 39].
5. Prevention and Dispensary Observation
All patients with the onset of the first symptoms characteristic of pilonidal sinus inflammation are recommended to have an appointment (examination, consultation) with a coloproctologist (in patients under 18 years of age - a pediatric surgeon) to determine the tactics of preventive measures aimed at preventing the development and progression of the disease. The examination and consultation are carried out as part of an initial or follow-up appointment (examination, consultation) with a coloproctologist or pediatric surgeon [1, 2, 19, 43].
GCP CLEL 5Grade of Recommendation – C (Level of Evidence – 5).
There is no specific prevention for pilonidal sinus inflammation. Prevention of acute inflammation mainly consists of general health-improving measures aimed at eliminating the etiological factors of the disease:
1) Compliance with personal hygiene rules, especially in the intergluteal cleft;
2) Support and strengthening of local and humoral immunity;
3) Treatment and sanitization of foci of acute and chronic infection;
4) Correction of chronic diseases, such as diabetes mellitus.
Patients after surgical treatment, as a prevention of recurrences, are recommended to undergo laser hair removal [40].
GCP CLEL 3Grade of Recommendation – C (Level of Evidence – 3).
Comment: multiple procedures are often required. Laser hair removal reduces the long-term recurrence rate. The recurrence rate after laser hair removal ranges from 0% to 28% [40].
6. Organization of Medical Care
6.1 Indications for hospital admission
A patient with acute pilonidal sinus inflammation may be hospitalized in a coloproctology or surgical department; patients under 18 years of age must be hospitalized in a pediatric surgery department.
A patient with chronic pilonidal sinus inflammation must be hospitalized in a coloproctology department; patients under 18 years of age must be hospitalized in a pediatric surgery department.
At the diagnosis stage, diagnostic measures in a scheduled setting can be carried out on an outpatient basis. Surgical treatment of adult patients can also be performed in a coloproctology day hospital setting.
6.2 Indications for patient discharge from a medical organization
Uncomplicated course of the early postoperative period (absence of increased bleeding tendencies, etc.);
Absence of purulent-septic complications in the area of postoperative wounds;
Controlled pain syndrome with the possibility of its management using oral medications in an outpatient setting.
7. Additional Information
Negative factors affecting treatment outcomes include:
Development of infectious complications;
Non-compliance by the patient with the restrictive regimen.
Criteria for Evaluating the Quality of Medical Care
Quality assessment criteria for primary health care provided to adults and children with pilonidal sinus (ICD-10 codes: L05.0; L05.9, L72.0)
No. | Quality assessment criteria | Evaluation of compliance |
|---|---|---|
1. | Incision and drainage of phlegmon (abscess) was performed (in case of acute inflammation of the pilonidal sinus) | Yes/No |
2. | Ultrasound examination of soft tissues (one anatomical zone) of the sacrococcygeal region was performed | Yes/No |
Quality assessment criteria for specialized medical care provided to adults and children with pilonidal sinus (ICD-10 codes: L05.0; L05.9; L72.0)
No. | Quality assessment criteria | Evaluation of compliance |
|---|---|---|
1. | Excision of the pilonidal sinus was performed (in uncomplicated forms of chronic pilonidal sinus inflammation) | Yes/No |
2. | Excision of the pilonidal sinus with or without local tissue flap plastic surgery was performed (in complicated forms of chronic pilonidal sinus inflammation) | Yes/No |
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Appendix A1. Working Group Composition
Full name | Academic degree | Academic degree | Professional association |
|---|---|---|---|
Anosov I.S. | Ph.D. in Medicine | Association of Coloproctologists of Russia | |
Achkasov S.I. | D.Sc. in Medicine | Corresponding Member of RAS, Professor | Association of Coloproctologists of Russia |
Biryukov O.M. | Ph.D. in Medicine | Association of Coloproctologists of Russia | |
Blagodarny L.A. | D.Sc. in Medicine | Professor | Association of Coloproctologists of Russia |
Vyshegorodtsev D.V. | D.Sc. in Medicine | Association of Coloproctologists of Russia | |
Groshilin V.S. | D.Sc. in Medicine | Professor | Association of Coloproctologists of Russia |
Kashnikov V.N. | D.Sc. in Medicine | Associate Professor | Association of Coloproctologists of Russia |
Korolik V.Yu. | Ph.D. in Medicine | Association of Coloproctologists of Russia | |
Kostarev I.V. | D.Sc. in Medicine | Associate Professor | Association of Coloproctologists of Russia |
Kuzminov A.M. | D.Sc. in Medicine | Professor | Association of Coloproctologists of Russia |
Moskalev A.I. | Ph.D. in Medicine | Association of Coloproctologists of Russia | |
Mudrov A.A. | D.Sc. in Medicine | Associate Professor | Association of Coloproctologists of Russia |
Muravyev A.V. | D.Sc. in Medicine | Professor | Association of Coloproctologists of Russia |
Popov D.E. | Ph.D. in Medicine | Association of Coloproctologists of Russia | |
Razumovsky A.Yu. | D.Sc. in Medicine | Corresponding Member of RAS, Professor | Association of Pediatric Surgeons of Russia |
Smirnov A.N. | D.Sc. in Medicine | Professor | Association of Pediatric Surgeons of Russia |
Titov A.Yu. | D.Sc. in Medicine | Association of Coloproctologists of Russia | |
Frolov S.A. | D.Sc. in Medicine | Professor | Association of Coloproctologists of Russia |
Kholostova V.V. | D.Sc. in Medicine | Professor | Association of Pediatric Surgeons of Russia |
Khitaryan A.G. | D.Sc. in Medicine | Professor | Association of Coloproctologists of Russia |
Shelygin Yu.A. | 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
Pediatric surgeons
General practitioners (family physicians)
Nursing staff
Medical students, residents, postgraduate students
Table 1. Levels of Evidence (LoE) rating scale 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 method control or individual randomized clinical trials and systematic reviews of studies of any design, except for randomized clinical 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. Scale for evaluating the level of reliability of evidence (LRE) for methods of prevention, treatment, and medical rehabilitation, including those based on natural therapeutic factors (preventive, therapeutic, and rehabilitative 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 for RCTs using 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. Scale for evaluating the level of clinical persuasiveness of recommendations (LCPR) for methods of prevention, diagnostics, treatment, and medical rehabilitation, including those based on natural therapeutic factors (preventive,
diagnostic, therapeutic, and rehabilitative interventions)
GoR | Definition |
|---|---|
A | Strong recommendation (all considered efficacy criteria (outcomes) are important, all studies have high or satisfactory methodological quality, and their conclusions regarding 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 guideline revision mechanism provides for their systematic updating 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 in the presence of justified additions/comments to previously approved clinical guidelines, but no more frequently 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 of November 21, 2011, "On the Fundamentals of Healthcare Protection in the Russian Federation".
Decree of the Government of the Russian Federation No. 1968 dated 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 and Social Development of the Russian Federation No. 206n dated April 2, 2010, “On Approval of the Procedure for Providing Medical Care to the Population with Coloproctological Diseases of the Colon, Anal Canal, and Perineum.”
Order of the Ministry of Health of the Russian Federation No. 168n dated 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 dated 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, for the Provision of Medical Care in Accordance with the Uniform Requirements of the Basic Compulsory Medical Insurance Program.”
Appendix B. Physician Action Algorithms
Appendix C. Patient Information
Pilonidal sinus disease (PSD, pilonidal cyst, pilonidal sinus) — a narrow epithelium-lined canal containing hair follicles and sebaceous glands, opening onto the skin of the sacrococcygeal region via one or more primary and, potentially, secondary fistula openings. The incidence of PSD is 26–48 per 100,000 population. Clinical manifestations are detected in the most socially active category of patients, predominantly aged 15 to 30 years. This disease is more common in individuals with excessive hair growth in the sacrococcygeal region.
In Russia, it is generally accepted that PSD is a congenital disease caused by a defect in the caudal region of the embryo, resulting in the formation of a tract beneath the skin of the intergluteal cleft, the inflammation of which most commonly develops with the onset of puberty. During this period, hair begins to grow within the lumen of the tract, and products of sweat and sebaceous glands accumulate. Abroad, it is considered an acquired disease caused by trauma to the sacrococcygeal region, abnormal hair growth, abundant hair coverage, and a deep intergluteal cleft, which leads to ingrown hairs and cyst formation. Obstruction of hair follicles leads to enlargement and rupture of sebaceous glands with the formation of an abscess or chronic inflammation of the PSD.
Classification of PSD by form:
- uncomplicated PSD (asymptomatic);
- acute PSD inflammation (infiltrative stage and abscess formation);
- chronic PSD inflammation (infiltrative stage, recurrent abscess, purulent fistula).
The main clinical manifestations of PSD inflammation include: pain in the sacrococcygeal region, purulent and serosanguinous discharge, localized hyperthermia, and fever. Symptoms depend on the form of the pilonidal sinus.
The uncomplicated form is characterized by one or more primary openings and is detected upon examination of the sacrococcygeal region.
Acute inflammation corresponds to all signs of a local inflammatory reaction — infiltrate, hyperemia, pain, abundant purulent discharge, and elevated body temperature.
Chronic inflammation is characterized by discomfort, mucous and purulent discharge, moisture, pruritus, and the presence of primary and secondary PSD openings. During exacerbation of the chronic inflammatory process, patients complain of pain in the sacrococcygeal region, purulent or serosanguinous discharge from the primary and secondary openings, elevated local and general body temperature, and discomfort.
The main method of treatment for pilonidal sinus disease is surgical. Surgical treatment is understood as the elimination of the pilonidal tract along with all primary openings, surrounding inflammation-altered tissues, and secondary fistulas.
The nature of the surgical intervention depends on the type of disease and the extent of the inflammatory process.
Minimally invasive interventions can be performed in patients with a straight pilonidal cyst tract, without purulent extensions and marked inflammatory tissue infiltration. The efficacy of these techniques reaches 80%. Minimally invasive treatments for PSD include laser thermal ablation of the pilonidal sinus and sinusectomy (subcutaneous excision of the PSD). In recurrent or advanced forms of the disease with multiple extensions into the right and left gluteal regions, asymmetric plastic surgeries aimed at eliminating extensive tissue defects are performed (Karydakis, Bascom, Limberg procedures, etc.).
Surgical intervention performed in accordance with the stage and form of the disease allows for a cure in 90% of cases. Prevention of acute inflammation consists of general health-improving measures (compliance with personal hygiene rules, supporting and strengthening the immune system, treatment and sanitation of acute and chronic infection foci, correction of chronic diseases such as diabetes mellitus). Patients after surgical treatment are advised to remove hair in the intergluteal cleft as a recurrence prevention measure.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
None.