GLUtEus Maximus Fascia Plasty Flap for Pilonidal Sinus

Pilonidal Sinus Clinical Trial

— GLUE  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03914729
• Other study ID #: 199323
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2019
• Source: Russian Society of Colorectal Surgeons
• Contact: Darya Shlyk, MD
• Phone: + 7-920-520-77-06
• Email: shlyk[@]kkmx.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pilonidal Sinus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	Clinic of Colorectal and Minimally Invasive Surgery - I.M. Sechenov First Moscow State Medical University	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Russian Society of Colorectal Surgeons

Country where clinical trial is conducted

Russian Federation, 

References & Publications (5)

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. Review. — View 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. Review. — View 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 Pilo — View 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. Review. — View Citation

Søndenaa K, Andersen E, Nesvik I, Søreide JA. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Operative time	The length of surgery in minutes	1 day
Secondary	Bloodloss	The amount of blood lost during surgery	1 day
Secondary	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
Secondary	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
Secondary	Surgical site infection rate	The rate of infectious inflammation of the wound as confirmed by the observing doctor	3 month after surgery
Secondary	Inhospital stay	The duration of treatment after surgery untill discharge from the hospital (in days)	30 days
Secondary	Wound hemorrhage rate	The rate of hemorrhage from wound edges	Within 30 days from surgery
Secondary	Wound seroma rate	The rate of seroma detection in the wound area as confirmed by soft tissues ultrasound	90 days after surgery
Secondary	Wound healing rate	The proportion of patients having their wound completely healed	6 months after surgery
Secondary	Wound healing speed	The time period between surgery and complete healing of the wound	5 years after surgery
Secondary	Secondary surgery rate	The rate of surgical procedures after initial surgery performed for recurrent disease and/or wound complications	5 years
Secondary	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
Secondary	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