ClinicalTrials.gg
CompletedNCT07271537Updated Dec 9, 2025

Karydakis Versus Limberg Flap for the Management of Primary Sacrococcygeal Pilonidal Sinus

An observational study in Pilonidal Cyst and Sinus Without Abscess, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.

Sponsored by Zagazig University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
352
Ages
18 Years and older
Sex
All
01

Study summary

study comparing the Karydakis and Limberg flaps

Read the detailed description

study comparing the Karydakis and Limberg flaps in management of pilonidal sinus

02

Conditions studied

  • Pilonidal Cyst and Sinus Without Abscess

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Keywords

  • pilonidal sinus
  • karydakis
  • limberg flap
03

In context

Pilonidal Sinus

109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.

This study's enrollment of 352 is above the median of 145 across 37 observational studies indexed under Pilonidal Sinus.

Browse Pilonidal Sinus studies →

Lead sponsor

Zagazig University is the lead sponsor of 459 studies on the registry; 77 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • lost follow up
  • refuse surgery
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
352 participants (actual)
Patient registry
No

Groups and cohorts

  • Karadakis flap

    Karadakis flap for managing pilonidal cyst

    Procedure: karydakis surgery

  • Limberg flap

    Procedure: Limberg flap

Interventions

  • Procedurekarydakis surgery

    karydakis surgery for managing pilonidal sinus

  • ProcedureLimberg flap

    using rheumboid flap to cover the defect after pilonidal sinus excision

06

What researchers measure

Primary outcomes

  1. sexual function comparison

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

    Time frame: 1 year

Secondary outcomes

  1. driving function evaluation

    driving evaluation after surgery through questionnaire modulated by our group and asked to the patients

    Time frame: 1 year

07

Study locations

1 site
  • Zagazig University
    Zagazig, Sharqia Province 1234, Egypt
08

References and documents

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 33993341 ↗
  • Habeeb 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 Jun 17. doi: 10.1002/wjs.70463. Online ahead of print. PubMed 42311045 ↗

Individual participant data

Plan to share: Yes — upon reasonable requirement

Supporting information: Study protocol, Statistical analysis plan

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2017 to primary completion in Jul 2024, 84 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 13, 2025
First posted
Dec 9, 2025
StartActual
Jul 1, 2017
Primary completionActual
Jul 1, 2024
CompletionActual
Jul 1, 2024
Last update
Dec 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07271537
Lead sponsor
Zagazig University
Responsible party
Tamer.A.A.M.Habeeb (professour, Zagazig University) — Principal investigator
First posted
Dec 9, 2025
Start date
Jul 1, 2017
Primary completion
Jul 1, 2024
Completion
Jul 1, 2024
Last update
Dec 9, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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