Fistulotomy With or Without Marsupialization for Treatment of Simple Anal Fistula

NCT ID: NCT03595839

Last Updated: 2018-10-18

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-07-01

Brief Summary

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Patients with simple anal fistula will undergo fistulotomy operation and will be divided into two groups: the first will undergo marsupialization of the laid open fistula track and second group will not undergo marsupialization. The effect of marsupialization on healing of anal fistula will be compared postoperatively.

Detailed Description

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Conditions

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Anal Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Fistulotomy with Marsupialization

Lay open and Marsupialization of the fistula track

Group Type ACTIVE_COMPARATOR

Fistulotomy

Intervention Type PROCEDURE

The fistula track is laid open after complete probing till the internal opening

Marsupialization

Intervention Type PROCEDURE

The laid open track will be marsupialized using interrupted absorbable sutures

Fistulotomy without Marsupialization

lay open of the fistula track

Group Type ACTIVE_COMPARATOR

Fistulotomy

Intervention Type PROCEDURE

The fistula track is laid open after complete probing till the internal opening

Interventions

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Fistulotomy

The fistula track is laid open after complete probing till the internal opening

Intervention Type PROCEDURE

Marsupialization

The laid open track will be marsupialized using interrupted absorbable sutures

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Both genders
* Age: 18-65 years
* All Patients with primary simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 25% of external anal sphincter fibers).

Exclusion Criteria

* High trans-sphincteric, extra-sphincteric, supra-sphincteric, secondary.
* Recurrent anal fistulas.
* Patients associated with anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases and TB.
* High risk patients according to ASA (American society of anesthesiologists )
* Any degree of incontinence.
* Patients with previous anal surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Emile

Lecturer of general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sameh Emile, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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mansoura60

Identifier Type: -

Identifier Source: org_study_id

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