GLUtEus Maximus Fascia Plasty Flap for Pilonidal Sinus

Study Overview
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Brief Summary
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Surgical treatment is still gold standard for pilonidal sinus disease. Several surgical techniques have been proposed to treat this disease in the last two decades. A new method - midline excision of pilonidal sinus and wound closure using gluteus maximus fascia plasty flap (GMFF) - was proposed recently as a new method of treatment that results in low reccurence rate and good cosmetic results. The aim of this study is to compare a new method (GMFF) with a traditional method (midline excision and primary closure) in terms of recurrence rate, complications and patient satisfaction with results.

Detailed Description
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Pilonidal sinus disease (PSD) is a rather rare benign condition (about 26 cases per 100,000 population) that affects primarily young adults. Because of purulent nature it is treated with surgery only. Traditional surgical techniques encompass midline excision of the purulent cyst and either leaving the wound lay open for secondary closure or midline primary closure. The latter method has a major drawback of high recurrence rate and very long healing and patient disability periods. Therefore alternative techniques to close the wound after pilonidal sinus excision were proposed. In some a muscular-cutaneous flaps are created and the wound is closed in a Z- or Y- or other shape manner. The recurrence rate of these techniques is significantly lower than with a traditional midline closure, but healing time and final cosmetic results are far from ideal in patient view. Recently a new method of wound closure was developed independently by a few groups that includes bilateral mobilisation of gluteus maximus muscles fascia and midline closure of the wound. Preliminary results demonstrated that this method leads to lower recurrence rate and better cosmetic results because the natal cleft is saved.

Official Title
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Multicenter Randomized Controlled Trial of Mobilized Gluteus Maximus Muscle Fascia Flap Versus Primary Closure in the Treatment of Primary and Recurrent Pilonidal Sinus Disease.

Conditions
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Pilonidal Sinus

Intervention / Treatment
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* Procedure: Primary Closure
* Procedure: Gluteus Maximus Fascia Plasty Flap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Chronic primary or recurrent pilonidal sinus at the remission stage. Presence or absence of secondary orifices. Planned surgical treatment with excision of pilonidal sinus. Location of secondary orifices less than 2 cm from the natal cleft. The distance between bilateral symmetrical secondary orifices less than 2 cm. American Society Anesthesiologists (ASA) score 1 to 3 Non-inclusion Criteria: Acute pilonidal sinus abscess. The secondary openings (orifice) position more than 2 cm from the midline. ASA 4-5. Predictable impossibility of following the protocol. Pregnancy Exclusion criteria: 1 The patients lost for the further observation. 2. The patient's refusal to continue participate in the investigation.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, multi-centre, parallel-arm randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Primary Closure<br>After pilonidal sinus is excised, subcutaneous fat and skin are closed in midline with a running suture | Procedure: Primary Closure<br>* A symmetrical elliptical incision of skin and subcutaneous fat around primary and secondary orifices is performed. The cyst is excised en bloc down to the sacral fascia and removed. The lateral edges of the wound are approximated and sutured in the midline: subcutaneous fat - with a running suture, skin - with a separate running suture.<br>|
| Active Comparator: Gluteus Maximus Plasty Flap<br>After pilonidal sinus is excised, gluteus maximus fascia flaps will be mobilised, approximated in the midline and fixed with a running suture. Subcutaneous fat and skin are closed in midline with a running suture. | Procedure: Gluteus Maximus Fascia Plasty Flap<br>* A symmetrical elliptical incision of skin and subcutaneous fat around primary and secondary orifices is performed. The cyst is excised en bloc down to the sacral fascia and removed. The lateral edges of the gluteus maximus muscles fascia bilaterally are mobilised in the direction from the fixation point to the sacrum and for 3-4 cm in lateral direction. The fascia flaps edges are approximated and fixed in the midline with a running suture. The subcutaneous fat is closed with a running suture, skin is closed with a separate running suture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | The rate of disease recurrence (clinical picture of pilonidal sinus and/or appearance of new openings in the intergluteal cleft and/or chronic unhealing wound and/or residual cavity in the wound area as confirmed by the soft tissue ultrasound) | starting from 6 months after surgery and up to 5 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | The length of surgery in minutes | 1 day | 
| Bloodloss | The amount of blood lost during surgery | 1 day | 
| Postoperative pain intensity - early postoperative period | Pain intensity will be evaluated twice a day (in the morning and in the evening) with a patient-reported Visual Analog Scale (VAS) that ranges from 0 to 10 with 0 representing no pain and 10 representing intolerable pain. A total score will be recorded. | On 1st, 3rd, 5th and 7th postoperative day | 
| Postoperative pain intensity - late postoperative period | Pain intensity will be evaluated once a day with a patient-reported Visual Analog Scale (VAS) that ranges from 0 to 10 with 0 representing no pain and 10 representing intolerable pain. A total score will be recorded. | On 10th, 14th, 21st, 30 day after surgery | 
| Surgical site infection rate | The rate of infectious inflammation of the wound as confirmed by the observing doctor | 3 month after surgery | 
| Inhospital stay | The duration of treatment after surgery untill discharge from the hospital (in days) | 30 days | 
| Wound hemorrhage rate | The rate of hemorrhage from wound edges | Within 30 days from surgery | 
| Wound seroma rate | The rate of seroma detection in the wound area as confirmed by soft tissues ultrasound | 90 days after surgery | 
| Wound healing rate | The proportion of patients having their wound completely healed | 6 months after surgery | 
| Wound healing speed | The time period between surgery and complete healing of the wound | 5 years after surgery | 
| Secondary surgery rate | The rate of surgical procedures after initial surgery performed for recurrent disease and/or wound complications | 5 years | 
| Patient satisfaction with cosmetic results | Patient-reported with a scale 0-10, where 0 corresponds to completely unsatisfactory and 10 corresponds to completely satisfactory. A total score is registered. | 6 months, 1 year, 3 years, 5 years after surgery | 
| Overall quality of life | Assessed with patient-reported questionnaire SF-36. A total score in each of 8 sections will be calculated and transformed into a 0-100 scale with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disability | 1-7 days before surgery, 1 month, 3 months, 1 year, 3 years, 5 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pilonidal sinus, plasty, gluteus muscle fascia, ano-coccygeal plasty