- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07271537
Karydakis Versus Limberg Flap for the Management of Primary Sacrococcygeal Pilonidal Sinus
November 26, 2025 updated by: Tamer.A.A.M.Habeeb, Zagazig University
Outcomes of Karydakis Versus Limberg Flap for the Management of Primary Sacrococcygeal Pilonidal Sinus
study comparing the Karydakis and Limberg flaps
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
study comparing the Karydakis and Limberg flaps in management of pilonidal sinus
Study Type
Observational
Enrollment (Actual)
352
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sharqia Province
-
Zagazig, Sharqia Province, Egypt, 1234
- Zagazig University
-
-
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
No
Sampling Method
Probability Sample
Study Population
all patients > 18 years with PNS underwent karydakis and limberg flap
Description
Inclusion Criteria:
- sexually active,
- employed or driving ,
- patients diagnosed with sacrococcygeal primary symptomatic pilonidal sinus based on clinical aspects, physical examination, and disease-specific history
Exclusion Criteria:
- lost follow up
- refuse surgery
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 |
|---|---|
|
Karadakis flap
Karadakis flap for managing pilonidal cyst
|
karydakis surgery for managing pilonidal sinus
|
|
Limberg flap
|
using rheumboid flap to cover the defect after pilonidal sinus excision
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sexual function comparison
Time Frame: 1 year
|
sexual function evaluation through questionnaire modulated by our group and asked to the patients
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
driving function evaluation
Time Frame: 1 year
|
driving evaluation after surgery through questionnaire modulated by our group and asked to the patients
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
July 1, 2017
Primary Completion (Actual)
July 1, 2024
Study Completion (Actual)
July 1, 2024
Study Registration Dates
First Submitted
November 13, 2025
First Submitted That Met QC Criteria
November 26, 2025
First Posted (Estimated)
December 9, 2025
Study Record Updates
Last Update Posted (Estimated)
December 9, 2025
Last Update Submitted That Met QC Criteria
November 26, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- pilonidal sinus
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
upon reasonable requirement
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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.