Pilonidal Cyst and Sinus Without AbscessNCT07271537
Karydakis Versus Limberg Flap for the Management of Primary Sacrococcygeal Pilonidal Sinus
An observational study of Pilonidal Cyst and Sinus Without Abscess, run by Zagazig University at 1 site in Egypt.
Trial summary
study comparing the Karydakis and Limberg flaps Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Cyst and Sinus Without Abscess
- What is being tested?
- karydakis surgery and Limberg flap
- Type of treatment
- Surgery or procedure
- How many people
- 352 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients > 18 years with PNS underwent karydakis and limberg flap
Who may be able to join
- sexually active,
- employed or driving ,
- patients diagnosed with sacrococcygeal primary symptomatic pilonidal sinus based on clinical aspects, physical examination, and disease-specific history
Who cannot join
- lost follow up
- refuse surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Karydakis Versus Limberg Flap for the Management of Primary Sacrococcygeal Pilonidal Sinus
study comparing the Karydakis and Limberg flaps
Read the detailed description
study comparing the Karydakis and Limberg flaps in management of pilonidal sinus
- Conditions
- Pilonidal Cyst and Sinus Without Abscess
- Being tested
- karydakis surgery, Limberg flap
- Keywords
- pilonidal sinus, karydakis, limberg flap
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
karydakis surgeryProcedure or surgery
karydakis surgery for managing pilonidal sinus
Limberg flapProcedure or surgery
using rheumboid flap to cover the defect after pilonidal sinus excision
| Study group | Role | What they receive |
|---|---|---|
| Karadakis flap | Karadakis flap for managing pilonidal cyst Receives: Procedure: karydakis surgery | |
| Limberg flap | Not described Receives: Procedure: Limberg flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
sexual function comparison
sexual function evaluation through questionnaire modulated by our group and asked to the patients
Measured: 1 year
Secondary outcomes (1)
driving function evaluation
driving evaluation after surgery through questionnaire modulated by our group and asked to the patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Jul 2017
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pilonidal Cyst and Sinus Without AbscessStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer.A.A.M.Habeeb, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271537
- Sponsor's protocol ID
- pilonidal sinus
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon reasonable requirement
Publications
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.
PubMed 33993341Habeeb TAAM, Hussain A, Bueno-Lledo J, Gimenez ME, Aiolfi A, Abdelsamad A, Chiaretti M, Kryvoruchko IA, Manangi MN, Algalaly NM, Abbas M, Labib MF, Almezaien O, Elkaseer MHM, Abdelkader HRM, Swelam M, Nagaty ME, Alhady MAAAAA, Henish MI, Farag H, Shalamesh MI, Shamy IAME, Fiad AA, Elbelkasi H, Alsaad MIA, Al-Shareef MM, Eissa MA, Elsadek MEA, Ali AKH, Youssef MZ, Mohamed MA, Hamdy A, Khedr AH, Khater AA, Ali HE, Siam M, Elnahas MN, Saqr MA, Ahmed MFI, Mohamed MMM, Elnemr M, Mousa B, Wasefy T, El Teliti AM, Abozaid M, Morsi A, Biomy TA, Atef B, Almeniawy MM, Moussa MS, Hebeishy MH, Metwally H, Bayomi MS, Mostafa A, Saleh AA, Yassin MA. Karydakis Versus Limberg Flap in Primary Sacrococcygeal Pilonidal Sinus: A Retrospective Comparative Study of Functional Recovery. World J Surg. 2026 Aug;50(8):2241-2256. doi: 10.1002/wjs.70463. Epub 2026 Jun 17.
PubMed 42311045
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Karydakis Versus Limberg Flap for the Management of Primary Sacrococcygeal Pilonidal Sinus
- ClinicalTrials.gov ID
- NCT07271537
- Acronym / sponsor ID
- pilonidal sinus
- Conditions
- Pilonidal Cyst and Sinus Without Abscess
- Keywords
- pilonidal sinus, karydakis, limberg flap
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
study comparing the Karydakis and Limberg flaps
Detailed description
study comparing the Karydakis and Limberg flaps in management of pilonidal sinus
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Karadakis flap | – | Procedure: karydakis surgeryKaradakis flap for managing pilonidal cyst |
| Limberg flap | – | Procedure: Limberg flap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients > 18 years with PNS underwent karydakis and limberg flap
Key inclusion criteria (3 listed)
- sexually active,
- employed or driving ,
- patients diagnosed with sacrococcygeal primary symptomatic pilonidal sinus based on clinical aspects, physical examination, and disease-specific history
Key exclusion criteria (2 listed)
- lost follow up
- refuse surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| karydakis surgerykarydakis surgery for managing pilonidal sinus | Procedure or surgery | Karadakis flap |
| Limberg flapusing rheumboid flap to cover the defect after pilonidal sinus excision | Procedure or surgery | Limberg flap |
Primary outcome
sexual function comparison
Time frame: 1 year
sexual function evaluation through questionnaire modulated by our group and asked to the patients
1 secondary outcome
driving function evaluation
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Background: PubMed 33993341Oetzmann 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.
- Derived from this study: PubMed 42311045Habeeb TAAM, Hussain A, Bueno-Lledo J, Gimenez ME, Aiolfi A, Abdelsamad A, Chiaretti M, Kryvoruchko IA, Manangi MN, Algalaly NM, Abbas M, Labib MF, Almezaien O, Elkaseer MHM, Abdelkader HRM, Swelam M, Nagaty ME, Alhady MAAAAA, Henish MI, Farag H, Shalamesh MI, Shamy IAME, Fiad AA, Elbelkasi H, Alsaad MIA, Al-Shareef MM, Eissa MA, Elsadek MEA, Ali AKH, Youssef MZ, Mohamed MA, Hamdy A, Khedr AH, Khater AA, Ali HE, Siam M, Elnahas MN, Saqr MA, Ahmed MFI, Mohamed MMM, Elnemr M, Mousa B, Wasefy T, El Teliti AM, Abozaid M, Morsi A, Biomy TA, Atef B, Almeniawy MM, Moussa MS, Hebeishy MH, Metwally H, Bayomi MS, Mostafa A, Saleh AA, Yassin MA. Karydakis Versus Limberg Flap in Primary Sacrococcygeal Pilonidal Sinus: A Retrospective Comparative Study of Functional Recovery. World J Surg. 2026 Aug;50(8):2241-2256. doi: 10.1002/wjs.70463. Epub 2026 Jun 17.
- Individual participant dataSharing planned: Yes. upon reasonable requirement
Related trials for Pilonidal Cyst and Sinus Without Abscess
Not yet recruiting
Laser Coagulation of Pilonidal Sinus With/Without Intraoperative Ultrasound Control
Pilonidal Cyst Without Abscess
Recruiting
The Effect of Local Anesthesia Techniques on Postoperative Pain After Laser Treatment of Pilonidal Sinus
Pilonidal Cyst and Sinus Without Abscess, Pilonidal Sinus Disease
Not yet recruitingObservational study
SiLaC Laser Technique for Pilonidal Sinus - La Paz Cohort Study.
Pilonidal Sinus Disorder, Pilonidal Cyst Without Abscess
Not yet recruiting
Comparing Minimally Invasive Treatments for Pilonidal Disease: LA POPA Trial (Laser And Pit-picking OR Pit-picking Alone)
Pilonidal Sinus, Pilonidal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilonidal Cyst and Sinus Without Abscess, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sexual function comparison (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07271537, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.