Comparative Study Between Wide Local Excision and Minimal Excision of Pilonidal Sinus

September 4, 2023 updated by: Abanoub emad fayez
Comparative study between wide local excision and minimal excision of pilonidal sinus

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pilonidal sinus (PNS) disease is distributed in young adults who are supposed to be healthy with maximum productivity. Wide local excision creates a tissue gap, while the concept of minimal excision preserves healthy tissues with minimal tissue gap.

Pilonidal disease is a frequent suppurative condition that occurs twice as often in men as in women, usually between the ages of 15 and 30. Pilonidal disease is located beneath the skin of the sacro-coccygeal region. It presents acutely as an abscess under tension while the chronic form gives rise to intermittent discharge from pilonidal sinus(es). Diagnosis is clinical and usually straightforward. In the large majority of cases, treatment is surgical but there is no consensus as to the 'ideal' technique. Acute abscess must be evacuated and an off-midline incision seems preferable. Excision is the standard definitive treatment but the choice of wide versus limited excision on the school of thought. Minimal excision or debridement of the sinus and/or cavity through a midline or a separate paramedian excision can also be performed, leaving the wounds open or closed. These methods are simple and cost-efficient, and associated with low pain, rapid healing, and a rapid return to normal activity. A disadvantage is the higher recurrence rate; however, these methods can be used repeatedly for recurrences. Although recurrence rates seem high at first glance, the procedures can be successfully repeated for recurrences, achieving healing rates of over 90% for 1-2 interventions. Future well-designed trials are necessary to aid patient selection.

Study Type

Observational

Enrollment (Estimated)

2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy people of both genders with or without history of PNS procedures before

Description

Inclusion Criteria:

  • Patients complaining of primary PNS and Recurrent PNS following Minimal excision

Exclusion Criteria:

  • Recurrent PNS following wide local excision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Wide local excision of pilonidal sinus
Procedure: Z plasty and minimal excision of pilonidal sinus
The investigators will perform a " Z plasty " procedure and Minimal excision procedure for patients complaining of pilonidal sinus and the investigators will compare the outcomes and rate of recurrence of these two procedures
Minimal excision of pilonidal sinus
Procedure: Z plasty and minimal excision of pilonidal sinus
The investigators will perform a " Z plasty " procedure and Minimal excision procedure for patients complaining of pilonidal sinus and the investigators will compare the outcomes and rate of recurrence of these two procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of recurrence
Time Frame: In about 6 month follow up
Showing each of both procedures efficacy in decreasing rate of recurrence of PNS
In about 6 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abanoub emad fayez

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Techniques of PNS excision

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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