NCT07786480

Brief Summary

There is a difference mean recovery time in patients undergoing Limberg Flap operation versus simple excision of Pilonidal sinus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

10 months

First QC Date

August 22, 2026

Last Update Submit

August 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Recovery time

    4 weeks

Study Arms (2)

Closure ure using limberg flap technique

Procedure: Limberg flap operation

Closure by simple excision

Procedure: Simple excision

Interventions

Pilonidal surgery by excision and closure using the Limberg flap technique. The excision and flap site will be mapped The ratio of length to width will be 60%. This rhomboid shape incision will be made and continued to the post sacral fascia and the tissue will be excised. Then the fascio-cutaneous flap will be divided from the underlying gluteus muscle and rotated to the defect. The wound will be closed with 2-0 nylon string after hemo-vaccum drain placement. Routine dressing will be performed and removed the day after operation

Closure ure using limberg flap technique

Pionidal sinus surgery by excision with primary closure only. The excision site will be marked 1 cm away from the sinus. Then an elliptical incision will be made that extended to the post sacral fascia. The tissue will be resected, and proper hemostasis will be done using minimum electrocautery. Tnen the wound will be closed in layers and a vaccum drain (Redivac) will be placed in a subcutaneous plane. Patients will be followed for 4 weeks and recovery time will be noted as per operational definition

Closure by simple excision

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patient admitted in Hospital

You may qualify if:

  • Paticnts of both gender
  • Age of 18-60 years
  • ASA physical status I and II
  • Diagnosed as having pilonidal sinus

You may not qualify if:

  • Patients with recurrent pilonidal sinus disease
  • Pegnant or lactating females
  • Patients with a psychiatric discase
  • ASA physical status ≥3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Faisal Masood teaching Hospital Sargodha

Sargodha, Punjab Province, 40100, Pakistan

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2026

First Posted

August 26, 2026

Study Start

February 25, 2025

Primary Completion

December 23, 2025

Study Completion

December 28, 2025

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations