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RecruitingNCT06508086Updated Jul 18, 2024

Pilonidal Sinus Disease

An interventional study of laser ablation technique in the treatment of pilonidal sinus and Karydakis technique in the treatment of pilonidal sinus in Pilonidal Sinus, sponsored by Sohag University. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-07-18.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Sex
All
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Study summary

The aim of this study is to compare the outcomes of Karydakis technique versus sinus tract ablation procedure using 1470 nm Diode laser for the treatment of pilonidal sinus and provide evidence-based guidance to select the most appropriate operative procedure.

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Conditions studied

  • Pilonidal Sinus

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03

In context

Pilonidal Sinus

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

This study's planned enrollment of 30 is below the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.

Browse Pilonidal Sinus studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

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

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

  • All patients with a clinical diagnosis of symptomatic uncomplicated pilonidal sinus, males or females, any age will be included in our study.

Exclusion criteria

Exclusion Criteria:

  • Patients with pilonidal abscess and any associated acute condition.
  • Patients with hidradenitis suppurativa.
  • Refusal.
  • Unfit for surgery.
  • Recurrence.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    group (A) LASER ABLATION

    Procedure: laser ablation technique in the treatment of pilonidal sinus

  • Active comparator
    group (B) KARYDAKIS TECHNIQUE

    Procedure: Karydakis technique in the treatment of pilonidal sinus

Interventions

  • Procedurelaser ablation technique in the treatment of pilonidal sinus

    group (A) will include patients with pilonidal sinus disease who will be operated by sinus tract ablation procedure using 1470 nm Diode laser

  • ProcedureKarydakis technique in the treatment of pilonidal sinus

    group (B) will include patients with pilonidal sinus disease who will be operated by Karydakis technique

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What researchers measure

Primary outcomes

  1. recurrence rate in the treatment of pilonidal disease

    the patients undergo follow up at the outpatient clinic for manifestations of recurrence eg. discharge, multiple pits

    Time frame: 6 months after the operation

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Guner A, Cekic AB, Boz A, Turkyilmaz S, Kucuktulu U. A proposed staging system for chronic symptomatic pilonidal sinus disease and results in patients treated with stage-based approach. BMC Surg. 2016 Apr 16;16:18. doi: 10.1186/s12893-016-0134-5. PubMed 27084534 ↗
  • Doll D, Matevossian E, Wietelmann K, Evers T, Kriner M, Petersen S. Family history of pilonidal sinus predisposes to earlier onset of disease and a 50% long-term recurrence rate. Dis Colon Rectum. 2009 Sep;52(9):1610-5. doi: 10.1007/DCR.0b013e3181a87607. PubMed 19690490 ↗
  • Dessily M, Charara F, Ralea S, Alle JL. Pilonidal sinus destruction with a radial laser probe: technique and first Belgian experience. Acta Chir Belg. 2017 Jun;117(3):164-168. doi: 10.1080/00015458.2016.1272285. Epub 2017 Jan 6. PubMed 28056720 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06508086
Lead sponsor
Sohag University
Responsible party
Assem Mahmoud Ahmed (Resident, Department of General Surgery, Faculty of Medicine, Sohag University, Sohag University) — Principal investigator
First posted
Jul 18, 2024
Start date
Jun 10, 2024
Primary completion
Jun 1, 2025 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Jul 18, 2024

Study contacts

Assem M Ahmed, Resident
Contact
asemereby3@gmail.com
01111544547

Oversight

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

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