GLUtEus Maximus Fascia Plasty Flap for Pilonidal Sinus (GLUE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pilonidal Sinus
• Intervention / Treatment: Procedure: Primary Closure; Procedure: Gluteus Maximus Fascia Plasty Flap

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 Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arcangelo Picciariello, MD; Phone Number: +393492185104; Email: picciariello@kkmx.ru
• Study Contact Backup: Name: Darya Shlyk, MD; Phone Number: + 7-920-520-77-06; Email: shlyk@kkmx.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119435
    • Recruiting
    • Clinic of Colorectal and Minimally Invasive Surgery - I.M. Sechenov First Moscow State Medical University
    • Contact: Darya + 7-920-520-77-06 Shlyk, MD; Phone Number: + 7-920-520-77-06; Email: shlyk@kkmx.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Primary Closure; After pilonidal sinus is excised, subcutaneous fat and skin are closed in midline with a running suture	Procedure: Primary Closure; 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.
Active Comparator: Gluteus Maximus 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.	Procedure: Gluteus Maximus Fascia Plasty Flap; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Russian Society of Colorectal Surgeons
• Investigators: Principal Investigator: Inna Tulina, PhD, I.M. Sechenov First Moscow State Medical University; Study Director: Petr Tsarkov, Prof., Russian Society of Colorectal Surgeons

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: April 11, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 11, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: pilonidal sinus; plasty; gluteus muscle fascia; ano-coccygeal plasty
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• Other Study ID Numbers: 199323

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No