NCT03914729

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

2.7 years

First QC Date

April 11, 2019

Last Update Submit

April 11, 2019

Conditions

Pilonidal Sinus

Keywords

pilonidal sinusplastygluteus muscle fasciaano-coccygeal plasty

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Operative time

    1 day

  • Bloodloss

    1 day

  • Postoperative pain intensity - early postoperative period

    On 1st, 3rd, 5th and 7th postoperative day

  • Postoperative pain intensity - late postoperative period

    On 10th, 14th, 21st, 30 day after surgery

  • Surgical site infection rate

    3 month after surgery

  • +8 more secondary outcomes

Study Arms (2)

Primary Closure

ACTIVE COMPARATOR

After pilonidal sinus is excised, subcutaneous fat and skin are closed in midline with a running suture

Procedure: Primary Closure

Gluteus Maximus Plasty Flap

ACTIVE COMPARATOR

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

Interventions

Primary ClosurePROCEDURE

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.

Primary Closure
Gluteus Maximus Fascia Plasty FlapPROCEDURE

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.

Gluteus Maximus Plasty Flap

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Acute pilonidal sinus abscess.
  • The secondary openings (orifice) position more than 2 cm from the midline.
  • ASA 4-5.
  • Predictable impossibility of following the protocol.
  • Pregnancy

You may not qualify if:

  • The patients lost for the further observation. 2. The patient's refusal to continue participate in the investigation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Moscow, 119435, Russia

RECRUITING

Related 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. doi: 10.1007/s101510300001.

    PMID: 12750948RESULT

  • 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.

    PMID: 7745322RESULT

  • 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.

    PMID: 27311698RESULT

  • 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.

    PMID: 29699781RESULT

  • 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.

    PMID: 30640830RESULT

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Officials

  • Inna Tulina, PhD

    I.M. Sechenov First Moscow State Medical University

    PRINCIPAL INVESTIGATOR

  • Petr Tsarkov, Prof.

    Russian Society of Colorectal Surgeons

    STUDY DIRECTOR

Central Study Contacts

Darya Shlyk, MD

CONTACT

+ 7-920-520-77-06shlyk@kkmx.ru

Arcangelo Picciariello, MD

CONTACT

+393492185104picciariello@kkmx.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, multi-centre, parallel-arm randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 16, 2019

Study Start

April 20, 2017

Primary Completion

December 30, 2019

Study Completion

December 30, 2024

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

RU(1)