Pilonidal Sinus Disease

NCT ID: NCT06508086

Last Updated: 2024-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-10

Study Completion Date

2025-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pilonidal Sinus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group (A) LASER ABLATION

Group Type ACTIVE_COMPARATOR

laser ablation technique in the treatment of pilonidal sinus

Intervention Type PROCEDURE

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

group (B) KARYDAKIS TECHNIQUE

Group Type ACTIVE_COMPARATOR

Karydakis technique in the treatment of pilonidal sinus

Intervention Type PROCEDURE

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

Interventions

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laser 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

Intervention Type PROCEDURE

Karydakis technique in the treatment of pilonidal sinus

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

* Patients with pilonidal abscess and any associated acute condition.
* Patients with hidradenitis suppurativa.
* Refusal.
* Unfit for surgery.
* Recurrence.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Assem Mahmoud Ahmed

Resident, Department of General Surgery, Faculty of Medicine, Sohag University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Assem M Ahmed, Resident

Role: CONTACT

01111544547

Facility Contacts

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Magdy M Amin, professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 27084534 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19690490 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28056720 (View on PubMed)

Other Identifiers

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Soh-Med-24-06-26MS

Identifier Type: -

Identifier Source: org_study_id

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