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

NCT ID: NCT04155905

Last Updated: 2019-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2019-04-30

Brief Summary

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

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.

Conditions

Anal Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group A fistulotomy group

35 patients with simple anal fistula subjected to fistulotomy

Group Type: ACTIVE_COMPARATOR

fistulotomy

Intervention Type: PROCEDURE

after defining the fistulous track it was laid open (marsupialization)

group B marsupialization group

35 patients with simple anal fistula subjected to fistulotomy and marsupialization of fistulotomy wound

Group Type: ACTIVE_COMPARATOR

fistulotomy and marsupialization of wound edges

Intervention Type: PROCEDURE

after defining the fistulous track it was laid open (marsupialization) was done together with marsupialization of the wound edge with vicryl 3\\0 sutures

Interventions

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

Intervention Type: PROCEDURE

fistulotomy

after defining the fistulous track it was laid open (marsupialization)

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hazem Nour Abdellatif

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zagazig Faculty of Medicine

Zagazig, Sharqya, Egypt

Countries

Egypt

Other Identifiers

marsupialization anal fistula

Identifier Type: -

Identifier Source: org_study_id