Excision and Reconstruction of the Natal Cleft With a Parasacral Perforator Flap Versus Open Excision With Secondary Healing, in the Management of Sacrococcygeal Pilonidal Disease.

NCT03534700 | Terminated

• 1 other identifier: RC31/16/8255
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

Chronic sacrococcygeal pilonidal disease is a common acquired condition associated with hirsutism that predominantly affects young male patients. Morbidity from this disease results in pain, embarrassment and loss of normal activities, causing absenteeism from work and school. Various surgical procedures have been described for the treatment of both primary and recurrent pilonidal disease counting: open excision and healing by secondary intention, marsupialization, excision and primary closure (midline or off-midline), excision and repair by flap. No single method has been accepted as the "gold standard", and none of them cancels the risk of recurrence. The optimal therapy for pilonidal sinus disease should be simple, with good aesthetic outcomes and a low recurrence rate. It must allow the return to normal activities quickly. The parasacral perforator flap seems to answer these entire requirements. No study compares this flap repair with the most common procedure, which is the open excision with secondary healing. The aim of this study is to assess the efficacy and the security of the reconstruction of the natal cleft with the perforator parasacral flap versus open excision with secondary healing in the treatment of sacrococcygeal pilonidal sinus.

Conditions

Pilonidal Disease

Keywords

sacrococcygeal pilonidal disease

Outcome Measures

Primary Outcomes (1)

• recurrence

  the rate of recurrence during a follow up of 2 years.

  2 years

Secondary Outcomes (2)

• cost-effectiveness

  2 years

• cost-utility

  2 years

Study Arms (2)

Open excision

ACTIVE COMPARATOR

open excision and healing by secondary intention, marsupialization, excision and primary closure (midline or off-midline), excision and repair by flap.

Procedure: open excision

parasacral flap reconstruction

EXPERIMENTAL

The parasacral perforator flap has been described. It appears to be a good alternative, offering all the benefits of the reconstruction of the natal cleft in terms of lower rate of recurrence and lower time for complete wound healing. It also gives a better aesthetic result.

Procedure: parasacral flap reconstruction

Interventions

parasacral flap reconstruction PROCEDURE

parasacral flap reconstruction

parasacral flap reconstruction

open excision PROCEDURE

open excision and healing by secondary intention, marsupialization, excision and primary closure (midline or off-midline), excision and repair by flap.

Open excision

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with primary or recurrent sacrococcygeal pilonidal sinus disease,
• Minimum delay of 1 month after an infection of the pilonidal areas,

You may not qualify if:

• Florid abcess in the pilonidal sinus,
• Impossibility of general anesthesia, allergy to methylene blue, anticoagulant therapy,

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (2)

University Hospital

Montpellier, 34295, France

Location

University hospital

Toulouse, 31059, France

Location

Study Officials

• Benoit CHAPUT, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: May 23, 2018
• Study Start: June 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 25, 2023
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)