Multicenter Randomized Controlled Trial of Mobilized Gluteus Maximus Muscle Fascia Flap Versus Primary Closure in the Treatment of Primary and Recurrent Pilonidal Sinus Disease.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pilonidal Sinus
- Sponsor
- Russian Society of Colorectal Surgeons
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Recurrence rate
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Recurrence rate
Time Frame: 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 Outcomes
- Operative time(1 day)
- Postoperative pain intensity - late postoperative period(On 10th, 14th, 21st, 30 day after surgery)
- Overall quality of life(1-7 days before surgery, 1 month, 3 months, 1 year, 3 years, 5 years after surgery)
- Bloodloss(1 day)
- Wound seroma rate(90 days after surgery)
- Wound healing rate(6 months after surgery)
- Postoperative pain intensity - early postoperative period(On 1st, 3rd, 5th and 7th postoperative day)
- Surgical site infection rate(3 month after surgery)
- Inhospital stay(30 days)
- Wound hemorrhage rate(Within 30 days from surgery)
- Wound healing speed(5 years after surgery)
- Secondary surgery rate(5 years)
- Patient satisfaction with cosmetic results(6 months, 1 year, 3 years, 5 years after surgery)