GLUtEus Maximus Fascia Plasty Flap for Pilonidal Sinus

Not Applicable

Recruiting

• Conditions: Pilonidal Sinus
• Interventions: Procedure: Primary Closure; Procedure: Gluteus Maximus Fascia Plasty Flap

• Registration Number: NCT03914729
• Lead Sponsor: Russian Society of Colorectal Surgeons

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-04-20
• Status Verified: 2019-04
• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2019-04-11
• Last Update Submitted: 2019-04-11
• Study First Posted: 2019-04-16
• Last Update Posted: 2019-04-16
• Primary Completion: 2019-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Written informed consent
2. Chronic primary or recurrent pilonidal sinus at the remission stage.
3. Presence or absence of secondary orifices.
4. Planned surgical treatment with excision of pilonidal sinus.
5. Location of secondary orifices less than 2 cm from the natal cleft.
6. The distance between bilateral symmetrical secondary orifices less than 2 cm.
7. American Society Anesthesiologists (ASA) score 1 to 3

Non-inclusion Criteria:

1. Acute pilonidal sinus abscess.
2. The secondary openings (orifice) position more than 2 cm from the midline.
3. ASA 4-5.
4. Predictable impossibility of following the protocol.
5. Pregnancy

Exclusion criteria:

1 The patients lost for the further observation. 2. The patient's refusal to continue participate in the investigation.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary Closure	Primary Closure	After pilonidal sinus is excised, subcutaneous fat and skin are closed in midline with a running suture
Gluteus Maximus Plasty Flap	Gluteus Maximus Fascia Plasty Flap	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.

Primary Outcome Measures

Name	Time	Method
Recurrence rate	starting from 6 months after surgery and up to 5 years after surgery	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)

Secondary Outcome Measures

Name	Time	Method
Operative time	1 day	The length of surgery in minutes
Postoperative pain intensity - late postoperative period	On 10th, 14th, 21st, 30 day after surgery	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.
Overall quality of life	1-7 days before surgery, 1 month, 3 months, 1 year, 3 years, 5 years after surgery	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
Bloodloss	1 day	The amount of blood lost during surgery
Wound seroma rate	90 days after surgery	The rate of seroma detection in the wound area as confirmed by soft tissues ultrasound
Wound healing rate	6 months after surgery	The proportion of patients having their wound completely healed
Postoperative pain intensity - early postoperative period	On 1st, 3rd, 5th and 7th postoperative day	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.
Surgical site infection rate	3 month after surgery	The rate of infectious inflammation of the wound as confirmed by the observing doctor
Inhospital stay	30 days	The duration of treatment after surgery untill discharge from the hospital (in days)
Wound hemorrhage rate	Within 30 days from surgery	The rate of hemorrhage from wound edges
Wound healing speed	5 years after surgery	The time period between surgery and complete healing of the wound
Secondary surgery rate	5 years	The rate of surgical procedures after initial surgery performed for recurrent disease and/or wound complications
Patient satisfaction with cosmetic results	6 months, 1 year, 3 years, 5 years after surgery	Patient-reported with a scale 0-10, where 0 corresponds to "completely unsatisfactory" and 10 corresponds to "completely satisfactory". A total score is registered.

Trial Locations

Locations (1)

Clinic of Colorectal and Minimally Invasive Surgery - I.M. Sechenov First Moscow State Medical University; 🇷🇺 Moscow, Russian Federation