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

Fistulotomy With Marsupialization Versus Fistulectomy With Wound Sutures in Simple Anal Fistula, a Comparative Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Fistula in Ano
• Intervention / Treatment: Procedure: fistulotomy and marsupialization; Procedure: fistulectomy and wound closure

Detailed Description

the investigators conducted this comparative clinical trial in the period between April 2017 and March 2019, on 92 patients with simple anal fistula, patients were randomly allocated into 2 groups, group I the fistulotomy group; 46 patients they underwent fistulotomy and marsupialization of wound edges. Group II, the fistulectomy group they underwent fistulectomy with closure of the wound.

Randomization was done using computer generated cards, the trial was approved by institutional review board (IRB) and the ethical committee of our hospitals, all study participants signed an informed written consent.

The condition of this trial is simple anal fistula defined as non-branched fistula confined to the lower third of the anal sphincter diagnosed by anorectal examination or MRI if needed, the primary outcomes are; the time taken for complete healing, fistula recurrence and anal incontinence diagnosed by Vaizey score patient's questionnaire. The secondary outcomes are local wound complications and postoperative pain calculated by visual analogue score (VAS). Study participants number was calculated through the IRB depending on the incidence of simple anal fistula in our locality.

inclusion criteria

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

exclusion criteria:

• Anorectal malignancy.
• Specific disease (Crohn's disease).
• ASA class III, VI and any contraindication for surgery
• Immunocompromised patients and those on steroid therapy or cytotoxic drugs.
• Perianal collection. participants of this study were subjected to proper history taking and full clinical examination for diagnosis of the condition, detection of any associated disease and \ or exclusion factor. MRI was ordered if there is any doubt about diagnosis, preoperative investigations were ordered as per usual.

The procedure in both groups was carried out by the study surgeons, under general anesthesia in lithotomy position, anorectal examination was done to identify the internal and external openings, course of fistulous track and any side tracks if present. When the internal opening couldn't be identified the operator used methylene blue dye injection through the external opening. In fistulotomy group and after probing of the track it was let open by diathermy, its floor was curetted and the wound edges marsupialized by polygalactin (Vicryl) sutures 3\0.

In fistulectomy group and after probing, the fistulous track was excised by diathermy together with its internal and external openings, after hemostasis the wound was closed by polygalactin (Vicryl) sutures 3\0.

In both groups the wound was dressed with non-adhesive dressing, Nonsteroidal analgesics were given as per need and participants were discharged after 24 hours if there is no contraindication to do so.

After discharge study participants were encouraged for self-cleaning by antiseptic baths.

Follow up was carried out in the outpatient clinics by the study surgeons, the clinic visits were planed every week for 12 weeks then monthly for another three months, in each visit the investigator recorded the state of wound healing, anal continence, postoperative pain, any local wound complications, and any recurrence after complete healing in the follow up time.

Preoperative data, demographic data, operative time, intraoperative complications and follow up data were collected and properly analyzed using paired t test and Z tests in SPSS 22 program package.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sharqya
    • Zagazig, Sharqya, Egypt, 44519
      • Zagazig Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: fistulotomy group; 46 patients with simple anal fistula underwent fistulotomy and marsupialization of wound edges	Procedure: fistulotomy and marsupialization; the anal fistula was laid open and the the wound edges was marsupialized using vicryle 3\0 sutures
Active Comparator: fistulectomy group; 46 patients with simple anal fistula underwent fistulectomy and closure of the wound	Procedure: fistulectomy and wound closure; anal fistula was excised with both openings and the wound was closed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participants with postoperative pain and its degree	degree of postoperative pain detected by visual analogue scale calculation	1 week
number of participants with post operative complications	post operative complications as bleeding and wound infection detected by clinical examination	1 week
operative time	time of the procedures calculated in minutes starting with the first incision to the start of wound dressing	1 hour

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: December 29, 2019
• First Submitted That Met QC Criteria: December 31, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 4, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: fistula in ano; fistulectomy wound closure; fistulotomy wound marsupialization
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: anal fistula wound

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No