Clinical trial NCT03914729: GLUtEus Maximus Fascia Plasty Flap for Pilonidal Sinus
Official title: Multicenter Randomized Controlled Trial of Mobilized Gluteus Maximus Muscle Fascia Flap Versus Primary Closure in the Treatment of Primary and Recurrent Pilonidal Sinus Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pilonidal Sinus
Keywords: pilonidal sinus
plasty
gluteus muscle fascia
ano-coccygeal plasty
Lead sponsor: Russian Society of Colorectal Surgeons
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 84
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multi-centre, parallel-arm randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence rate
timeFrame: starting from 6 months after surgery and up to 5 years after surgery
Secondary outcomes:
measure: Operative time
timeFrame: 1 day
measure: Bloodloss
timeFrame: 1 day
measure: Postoperative pain intensity - early postoperative period
timeFrame: On 1st, 3rd, 5th and 7th postoperative day
measure: Postoperative pain intensity - late postoperative period
timeFrame: On 10th, 14th, 21st, 30 day after surgery
measure: Surgical site infection rate
timeFrame: 3 month after surgery
measure: Inhospital stay
timeFrame: 30 days
measure: Wound hemorrhage rate
timeFrame: Within 30 days from surgery
measure: Wound seroma rate
timeFrame: 90 days after surgery
measure: Wound healing rate
timeFrame: 6 months after surgery
measure: Wound healing speed
timeFrame: 5 years after surgery
measure: Secondary surgery rate
timeFrame: 5 years
measure: Patient satisfaction with cosmetic results
timeFrame: 6 months, 1 year, 3 years, 5 years after surgery
measure: Overall quality of life
timeFrame: 1-7 days before surgery, 1 month, 3 months, 1 year, 3 years, 5 years after surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Clinic of Colorectal and Minimally Invasive Surgery - I.M. Sechenov First Moscow State Medical University
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University
name: Inna Tulina, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Russian Society of Colorectal Surgeons
name: Petr Tsarkov, Prof.
role: STUDY_DIRECTOR
References:
citation: Chintapatla S, Safarani N, Kumar S, Haboubi N. Sacrococcygeal pilonidal sinus: historical review, pathological insight and surgical options. Tech Coloproctol. 2003 Apr;7(1):3-8. doi: 10.1007/s101510300001.
citation: Sondenaa K, Andersen E, Nesvik I, Soreide JA. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42. doi: 10.1007/BF00337585.
citation: Iesalnieks I, Ommer A, Petersen S, Doll D, Herold A. German national guideline on the management of pilonidal disease. Langenbecks Arch Surg. 2016 Aug;401(5):599-609. doi: 10.1007/s00423-016-1463-7. Epub 2016 Jun 16.
citation: Milone M, Velotti N, Manigrasso M, Anoldo P, Milone F, De Palma GD. Long-term follow-up for pilonidal sinus surgery: A review of literature with metanalysis. Surgeon. 2018 Oct;16(5):315-320. doi: 10.1016/j.surge.2018.03.009. Epub 2018 Apr 24.
citation: Johnson EK, Vogel JD, Cowan ML, Feingold DL, Steele SR; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons' Clinical Practice Guidelines for the Management of Pilonidal Disease. Dis Colon Rectum. 2019 Feb;62(2):146-157. doi: 10.1097/DCR.0000000000001237. No abstract available.