Fistulotomy With Marsupialization Versus Fistulectomy With Wound Sutures in Simple Anal Fistula

NCT04215718 | Completed

• 1 other identifier: anal fistula wound
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

comparison between fistulectomy wound closure and fistulotomw wound marsupialization in treatment of simple anal fistula

Conditions

Fistula in Ano

Keywords

fistula in ano; fistulectomy wound closure; fistulotomy wound marsupialization

Outcome Measures

Primary Outcomes (3)

• healing time

  time taken for complete epithelialization of the wound detected by clinical examination

  8 weeks

• number of participants with recurrence of anal fistula

  presence of anal fistula after complete wound healing detected by clinical examination

  6 months

• number of participants with anal incontinence

  inability to control stool or flatus diagnosed by Vaizey score questionaire

  i months

Secondary Outcomes (3)

• number of participants with postoperative pain and its degree

  1 week

• number of participants with post operative complications

  1 week

• operative time

  1 hour

Study Arms (2)

fistulotomy group

ACTIVE COMPARATOR

46 patients with simple anal fistula underwent fistulotomy and marsupialization of wound edges

Procedure: fistulotomy and marsupialization

fistulectomy group

ACTIVE COMPARATOR

46 patients with simple anal fistula underwent fistulectomy and closure of the wound

Procedure: fistulectomy and wound closure

Interventions

fistulotomy and marsupialization PROCEDURE

the anal fistula was laid open and the the wound edges was marsupialized using vicryle 3\\0 sutures

fistulotomy group

fistulectomy and wound closure PROCEDURE

anal fistula was excised with both openings and the wound was closed

fistulectomy group

Eligibility Criteria

• Age: 18 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients above 18 years diagnosed with simple non recurrent anal fistula.

You may not qualify if:

• Anorectal malignancy.
• Specific disease (Crohn's disease).
• ASA class III, VI and any contraindication for surgery
• Immunocompromized patients and those on steroid therapy or cytotoxic drugs.
• Perianal collection.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig Faculty of Medicine

Zagazig, Sharqya, 44519, 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

• hazem nour, MD

  zag university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the patients don't know which procedure they underwent
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 2 groups of patients with simple anal fistula each one 46 patients the1st underwent fistulotomy with marsupialization of wound edges the second underwent fistulectomy and wound closure

Study Record Dates

• First Submitted: December 29, 2019
• First Posted: January 2, 2020
• Study Start: April 1, 2017
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)