Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure

NCT ID: NCT03426449

Last Updated: 2018-02-09

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

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2018-01-01

Brief Summary

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The present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock with posterolateral internal sphincterotomy at 5 o'clock in regards healing time, postoperative recurrence and complications, particularly fecal incontinence.

Detailed Description

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The present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock with posterolateral internal sphincterotomy at 5 o'clock in regards healing time, postoperative recurrence and complications, particularly fecal incontinence. We hypothesized that performing internal sphincterotomy in a point midway between the standard lateral position and the posterior midline position would confer better healing and relief of symptoms with less incidence of fecal incontinence while avoiding the development of keyhole deformity.

Conditions

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Anal Fissure

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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Posterolateral sphincterotomy

Division of internal anal sphincter at 5 o'clock position

Group Type ACTIVE_COMPARATOR

posterolateral sphincterotomy

Intervention Type PROCEDURE

Fissurectomy and limited division of internal anal sphincter at 5 o'clock position for 8-10 mm

Lateral sphincterotomy

Division of internal anal sphincter at 3 o'clock position

Group Type ACTIVE_COMPARATOR

lateral sphincterotomy

Intervention Type PROCEDURE

Fissurectomy and limited division of internal anal sphincter at 3 o'clock position for 8-10 mm

Interventions

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posterolateral sphincterotomy

Fissurectomy and limited division of internal anal sphincter at 5 o'clock position for 8-10 mm

Intervention Type PROCEDURE

lateral sphincterotomy

Fissurectomy and limited division of internal anal sphincter at 3 o'clock position for 8-10 mm

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult patients of both genders with chronic posterior anal fissure were included to the study.

Exclusion Criteria

* Patients with anterior or lateral anal fissure,
* patients with previous anal surgery,
* patients with concomitant anorectal pathology,
* patients with secondary anal fissure due to Crohn's disease or other specific etiology,
* patients with any degree of fecal incontinence,
* patients with active anorectal sepsis.
Minimum Eligible Age

16 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 H Emile, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

Locations

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Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

References

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Alawady M, Emile SH, Abdelnaby M, Elbanna H, Farid M. Posterolateral versus lateral internal anal sphincterotomy in the treatment of chronic anal fissure: a randomized controlled trial. Int J Colorectal Dis. 2018 Oct;33(10):1461-1467. doi: 10.1007/s00384-018-3087-6. Epub 2018 May 19.

Reference Type DERIVED
PMID: 29779044 (View on PubMed)

Other Identifiers

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mansourau45

Identifier Type: -

Identifier Source: org_study_id

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