Endoscopic Pilonidal Sinus Treatment (EPSIT) Versus Sinus Laser Closure (SiLaC) Versus Lay Open Technique

NCT ID: NCT04418336

Last Updated: 2020-06-09

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-06-02

Brief Summary

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Aim of the work To compare Sinus Laser closure versus lay open technique versus Endoscopic pilonidal sinus treatment as regards recurrence rate, operative data, postoperative pain, intra and postoperative complications, healing time and return to daily activity.

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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Endoscopic Pilonidal sinus treatment (EPSIT)

Endoscopic Pilonidal sinus treatment (EPSIT)

Group Type ACTIVE_COMPARATOR

Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique

Intervention Type PROCEDURE

Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique in sacrococcygeal Pilonidal sinus treatment

Sinus Laser Closure (SiLaC)

Sinus Laser Closure (SiLaC)

Group Type ACTIVE_COMPARATOR

Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique

Intervention Type PROCEDURE

Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique in sacrococcygeal Pilonidal sinus treatment

lay open technique

lay open technique

Group Type ACTIVE_COMPARATOR

Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique

Intervention Type PROCEDURE

Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique in sacrococcygeal Pilonidal sinus treatment

Interventions

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Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique

Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique in sacrococcygeal Pilonidal sinus treatment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with symptoms from sacrococcygeal pilonidal sinus .

Exclusion Criteria

* Abscess formation
* Immunodeficiency.
* Patients with congenital asymptomatic pits.
* Patient with psychiatric disease disabling surgical intervention. . Pregnant females.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed Arnouse

Role: CONTACT

01099222561

Facility Contacts

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Mohamed Hamada Mohamed Hamada

Role: primary

+20 109 212 7930

Other Identifiers

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R.19.04.495.R1 - 2019/05/12

Identifier Type: -

Identifier Source: org_study_id

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