Fistulotomy With or Without Marsupialization for Treatment of Simple Anal Fistula

NCT03595839 | Completed

• 1 other identifier: mansoura60
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anal Fistula

Outcome Measures

Primary Outcomes (1)

• Time to complete healing

  The duration of time required to achieve complete wound healing

  8 weeks

Study Arms (2)

Fistulotomy with Marsupialization

ACTIVE COMPARATOR

Lay open and Marsupialization of the fistula track

Procedure: Fistulotomy; Procedure: Marsupialization

Fistulotomy without Marsupialization

ACTIVE COMPARATOR

lay open of the fistula track

Procedure: Fistulotomy

Interventions

Fistulotomy PROCEDURE

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

Fistulotomy with Marsupialization; Fistulotomy without Marsupialization

Marsupialization PROCEDURE

The laid open track will be marsupialized using interrupted absorbable sutures

Fistulotomy with Marsupialization

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sameh Emile, M.D.

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of general surgery

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 23, 2018
• Study Start: February 1, 2017
• Primary Completion: March 30, 2018
• Study Completion: July 1, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)