Back to results

Fistulotomy With or Without Marsupialization for Treatment of Simple Anal Fistula

Primary Purpose

Anal Fistula

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Fistulotomy

Marsupialization

About this trial

This is an interventional treatment trial for Anal Fistula

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Both genders
Age: 18-65 years
All Patients with primary simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 25% of external anal sphincter fibers).

Exclusion Criteria:

High trans-sphincteric, extra-sphincteric, supra-sphincteric, secondary.
Recurrent anal fistulas.
Patients associated with anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases and TB.
High risk patients according to ASA (American society of anesthesiologists )
Any degree of incontinence.
Patients with previous anal surgery.

Sites / Locations

Mansoura university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Fistulotomy with Marsupialization

Fistulotomy without Marsupialization

Arm Description

Lay open and Marsupialization of the fistula track

lay open of the fistula track

Outcomes

Primary Outcome Measures

Time to complete healing

The duration of time required to achieve complete wound healing

Secondary Outcome Measures

Full Information

NCT ID

NCT03595839

First Posted

July 11, 2018

Last Updated

October 16, 2018

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT03595839

Brief Title

Fistulotomy With or Without Marsupialization for Treatment of Simple Anal Fistula

Official Title

Fistuolotomy With or Without Marsupialization for Treatment of Simple Anal Fistula: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

February 1, 2017 (Actual)

Primary Completion Date

March 30, 2018 (Actual)

Study Completion Date

July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Patients with simple anal fistula will undergo fistulotomy operation and will be divided into two groups: the first will undergo marsupialization of the laid open fistula track and second group will not undergo marsupialization. The effect of marsupialization on healing of anal fistula will be compared postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anal Fistula

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fistulotomy with Marsupialization

Arm Type

Active Comparator

Arm Description

Lay open and Marsupialization of the fistula track

Arm Title

Fistulotomy without Marsupialization

Arm Type

Active Comparator

Arm Description

lay open of the fistula track

Intervention Type

Procedure

Intervention Name(s)

Fistulotomy

Intervention Description

The fistula track is laid open after complete probing till the internal opening

Intervention Type

Procedure

Intervention Name(s)

Marsupialization

Intervention Description

The laid open track will be marsupialized using interrupted absorbable sutures

Primary Outcome Measure Information:

Title

Time to complete healing

Description

The duration of time required to achieve complete wound healing

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Both genders Age: 18-65 years All Patients with primary simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 25% of external anal sphincter fibers). Exclusion Criteria: High trans-sphincteric, extra-sphincteric, supra-sphincteric, secondary. Recurrent anal fistulas. Patients associated with anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases and TB. High risk patients according to ASA (American society of anesthesiologists ) Any degree of incontinence. Patients with previous anal surgery.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sameh Emile, M.D.

Organizational Affiliation

Mansoura University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mansoura university hospital

City

Mansourah

State/Province

Dakahlia

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Fistulotomy With or Without Marsupialization for Treatment of Simple Anal Fistula

We'll reach out to this number within 24 hrs