GLUtEus Maximus Fascia Plasty Flap for Pilonidal Sinus (GLUE)

• ClinicalTrials.gov Identifier: NCT03914729
• Recruitment Status: Recruiting
• First Posted: April 16, 2019
• Last Update Posted: April 16, 2019
• Sponsor: Russian Society of Colorectal Surgeons
• Information provided by (Responsible Party): Russian Society of Colorectal Surgeons

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pilonidal Sinus	Procedure: Primary Closure; Procedure: Gluteus Maximus Fascia Plasty Flap	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, multi-centre, parallel-arm randomized controlled trial
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: April 20, 2017
• Estimated Primary Completion Date: December 30, 2019
• Estimated Study Completion Date: December 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Operative time [ Time Frame: 1 day ]
   The length of surgery in minutes
2. Bloodloss [ Time Frame: 1 day ]
   The amount of blood lost during surgery
3. Postoperative pain intensity - early postoperative period [ Time Frame: 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.
4. Postoperative pain intensity - late postoperative period [ Time Frame: 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.
5. Surgical site infection rate [ Time Frame: 3 month after surgery ]
   The rate of infectious inflammation of the wound as confirmed by the observing doctor
6. Inhospital stay [ Time Frame: 30 days ]
   The duration of treatment after surgery untill discharge from the hospital (in days)
7. Wound hemorrhage rate [ Time Frame: Within 30 days from surgery ]
   The rate of hemorrhage from wound edges
8. Wound seroma rate [ Time Frame: 90 days after surgery ]
   The rate of seroma detection in the wound area as confirmed by soft tissues ultrasound
9. Wound healing rate [ Time Frame: 6 months after surgery ]
   The proportion of patients having their wound completely healed
10. Wound healing speed [ Time Frame: 5 years after surgery ]
    The time period between surgery and complete healing of the wound
11. Secondary surgery rate [ Time Frame: 5 years ]
    The rate of surgical procedures after initial surgery performed for recurrent disease and/or wound complications
12. Patient satisfaction with cosmetic results [ Time Frame: 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.
13. Overall quality of life [ Time Frame: 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

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Darya Shlyk, MD; + 7-920-520-77-06; shlyk@kkmx.ru

Contact: Arcangelo Picciariello, MD; +393492185104; picciariello@kkmx.ru

Locations

Russian Federation

Clinic of Colorectal and Minimally Invasive Surgery - I.M. Sechenov First Moscow State Medical University; Recruiting

Moscow, Russian Federation, 119435

Contact: Darya + 7-920-520-77-06 Shlyk, MD + 7-920-520-77-06 shlyk@kkmx.ru

Sponsors and Collaborators

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

More Information

Publications of Results:

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.

• Responsible Party: Russian Society of Colorectal Surgeons
• ClinicalTrials.gov Identifier: NCT03914729
• Other Study ID Numbers: 199323
• First Posted: April 16, 2019
• Last Update Posted: April 16, 2019
• Last Verified: April 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Russian Society of Colorectal Surgeons:

pilonidal sinus; plasty; gluteus muscle fascia; ano-coccygeal plasty

Additional relevant MeSH terms:

Pilonidal Sinus; Cysts; Neoplasms