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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 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-01-03

No results posted yet for this study

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

Interventions

PROCEDURE

parasacral flap reconstruction

parasacral flap reconstruction

PROCEDURE

open excision

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

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Benoit CHAPUT, MD · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2020-09-01
Completion
2023-09-25

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03534700 on ClinicalTrials.gov