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

Not yet recruiting

• Conditions: Pilonidal Sinus
• Interventions: Procedure: Z plasty and minimal excision of pilonidal sinus

• Registration Number: NCT06021392
• Lead Sponsor: Abanoub emad fayez

Brief Summary

Comparative study between wide local excision and minimal excision of pilonidal sinus

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 Timeline

• Study First Submitted: 2023-08-28
• Study First Submitted QC: 2023-08-28
• Status Verified: 2023-09
• Study First Posted: 2023-09-01
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-07
• Study Start: 2023-12-01
• Primary Completion: 2025-08-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

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

Exclusion Criteria

• Recurrent PNS following wide local excision

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Wide local excision of pilonidal sinus	Z plasty and minimal excision of pilonidal sinus	-
Minimal excision of pilonidal sinus	Z plasty and minimal excision of pilonidal sinus	-

Primary Outcome Measures

Name	Time	Method
Rate of recurrence	In about 6 month follow up	Showing each of both procedures efficacy in decreasing rate of recurrence of PNS