NCT06021392

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

August 28, 2023

Last Update Submit

September 4, 2023

Conditions

Pilonidal Sinus

Outcome Measures

Primary Outcomes (1)

  • Rate of recurrence

    Showing each of both procedures efficacy in decreasing rate of recurrence of PNS

    In about 6 month follow up

Study Arms (2)

Wide local excision of pilonidal sinus

Procedure: Z plasty and minimal excision of pilonidal sinus

Minimal excision of pilonidal sinus

Procedure: Z plasty and minimal excision of pilonidal sinus

Interventions

Z plasty and minimal excision of pilonidal sinusPROCEDURE

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 sinusWide local excision of pilonidal sinus

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Recurrent PNS following wide local excision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident doctor in Assiut university hospitals

Study Record Dates

First Submitted

August 28, 2023

First Posted

September 1, 2023

Study Start

December 1, 2023

Primary Completion

August 1, 2025

Study Completion

October 1, 2025

Last Updated

September 7, 2023

Record last verified: 2023-09