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

NCT04155905 | Completed

• 1 other identifier: marsupialization anal fistula
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Anal Fistula

Keywords

simple anal fistula; marsupialization

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

group A fistulotomy group

ACTIVE COMPARATOR

35 patients with simple anal fistula subjected to fistulotomy

Procedure: fistulotomy

group B marsupialization group

ACTIVE COMPARATOR

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

Procedure: fistulotomy and marsupialization of wound edges

Interventions

fistulotomy and marsupialization of wound edges 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

group B marsupialization group

fistulotomy PROCEDURE

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

group A fistulotomy group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

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 Design

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

Model Details: comparison between two groups of patients with simple anal fistula subjected to different types of treatment

Study Record Dates

• First Submitted: November 2, 2019
• First Posted: November 7, 2019
• Study Start: May 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: November 12, 2019

Record last verified: 2019-11

Locations

EG (1)