NCT07271537

Brief Summary

study comparing the Karydakis and Limberg flaps

Trial Health

87
On Track

Trial Health Score

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

Enrollment
352

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
Last Updated

December 9, 2025

Status Verified

November 1, 2025

Enrollment Period

7 years

First QC Date

November 13, 2025

Last Update Submit

November 26, 2025

Conditions

Pilonidal Cyst and Sinus Without Abscess

Keywords

pilonidal sinuskarydakislimberg flap

Outcome Measures

Primary Outcomes (1)

  • sexual function comparison

    sexual function evaluation through questionnaire modulated by our group and asked to the patients

    1 year

Secondary Outcomes (1)

  • driving function evaluation

    1 year

Study Arms (2)

Karadakis flap

Karadakis flap for managing pilonidal cyst

Procedure: karydakis surgery

Limberg flap

Procedure: Limberg flap

Interventions

karydakis surgeryPROCEDURE

karydakis surgery for managing pilonidal sinus

Karadakis flap
Limberg flapPROCEDURE

using rheumboid flap to cover the defect after pilonidal sinus excision

Limberg flap

Eligibility Criteria

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

all patients \> 18 years with PNS underwent karydakis and limberg flap

You may qualify if:

  • sexually active,
  • employed or driving ,
  • patients diagnosed with sacrococcygeal primary symptomatic pilonidal sinus based on clinical aspects, physical examination, and disease-specific history

You may not qualify if:

  • lost follow up
  • refuse surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University

Zagazig, Sharqia Province, 1234, Egypt

Location

Related Publications (1)

  • Oetzmann von Sochaczewski C, Godeke J. Pilonidal sinus disease on the rise: a one-third incidence increase in inpatients in 13 years with substantial regional variation in Germany. Int J Colorectal Dis. 2021 Oct;36(10):2135-2145. doi: 10.1007/s00384-021-03944-4. Epub 2021 May 16.

    PMID: 33993341BACKGROUND

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professour

Study Record Dates

First Submitted

November 13, 2025

First Posted

December 9, 2025

Study Start

July 1, 2017

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

December 9, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

upon reasonable requirement

Shared Documents
STUDY PROTOCOL, SAP

Locations

EG(1)