Marsupialization of Anal Fistulotomy Wound Accelerates Healing and Decreases Post Operative Pain

Fistulotomy Versus Fistulotomy With Marsupialization of Wound Edges in Simple Perianal Fistula, a Comparative Clinical Trial

comparison between to groups of patients with simple anal fistula one group underwent sistulotomy the other underwent fistulotomy and marsupialization of the wound edges , the investigator tested the incidence of postoperative complications , time of wound healing , operative time

Study Overview

• Status: Completed
• Conditions: Anal Fistula
• Intervention / Treatment: Procedure: fistulotomy; Procedure: fistulotomy and marsupialization of wound edges

Detailed Description

This randomized controlled trial was carried in the period between May 2018 and April 2019, on 70 patients undergoing fistulotomy for treatment of simple perianal fistula. Patients were randomly allocated into two equal groups each 35 patients, group A; underwent fistulotomy without marsupialization of the edges of fistulotomy wound. And group B; underwent fistulotomy with marsupialization of the wound edges.

Patients included in this study are those suffering simple non recurrent perianal fistula with ASA I and II.

the investigator excluded patients with secondary anal fistula, complex fistula, anal incontinence, previous anal surgery and any disease or drug that affects wound healing.

All patients were subjected to thorough history taking and careful anal examination to assess the sphincter integrity, define the fistulous track and internal opening, endo anal ultrasound or magnetic resonance imaging was ordered when needed.

Fistulotomy was done under spinal anesthesia in the lithotomy position after skin preparation and patient draping; anal examination under anesthesia was done, identification of the internal opening carried out using palpation and inspection using proctoscope, injection of hydrogen peroxide in the external opening done if internal opening couldn't be defined easily, then the fistulous track was probed, it was laid open using diathermy, in group B the wounds was marsupialized by suturing the skin edges to the edges of the track floor using absorbable sutures (polygalactin) 3\0. Figures (1) and (2) shows the probed fistulous track and its' wound after marsupialization.

Postoperative non adherent dressing impregnated with local anesthetic cream was applied to the wound.

Nonsteroidal analgesic injection was given in injection form as per need. Follow up was carried out in outpatient clinic by the study surgeons, patients who agreed for participation in the study was instructed to visit the clinic every week for the first three post-operative months then every month for the next 3 months and lastly two visits after 3 and 6 months, the attending surgeon records follow up data including status of wound healing, anal continence and fistula recurrence.

An informed written consent was taken from all study participants. Randomization was done using computer program. The study was approved from institutional review board and the ethical committee from our university.

Demographic data, operative data, and postoperative data including pain, post-operative complications and time taken for complete wound healing were collected, properly analyzed using the paired t test and Z test using SPSS program.

• Study Type: Interventional
• Enrollment (Actual): 70
• 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: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Simple non recurrent perianal fistula with ASA I and II.

Exclusion Criteria:

• secondary anal fistula,
• complex fistula,
• anal incontinence,
• previous anal surgery
• Any disease or drug that affects wound healing.

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: group A fistulotomy group; 35 patients with simple anal fistula subjected to fistulotomy	Procedure: fistulotomy; after defining the fistulous track it was laid open (marsupialization)
Active Comparator: group B marsupialization group; 35 patients with simple anal fistula subjected to fistulotomy and marsupialization of fistulotomy wound	Procedure: fistulotomy and marsupialization of wound edges; after defining the fistulous track it was laid open (marsupialization) was done together with marsupialization of the wound edge with vicryl 3\0 sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time in minutes	the time taken for completion of the procedure from fistulous track identification to the end of fistulotomy or marsupialization	intraoperative
postoperative pain using visual analogue scale	pain in the postoperative period	1 week
postoperative complications measured by clinical examination and anal sphincter manometry	examination of the patient for fistula recurrence, history, clinical examination and anal sphincter manometry for anal incontinence	1 year
wound healing time	time taken for wound to be completely healed	1 year

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: November 2, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: simple anal fistula; 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: marsupialization anal fistula

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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