Fistulotomy With or Without Marsupialization for Treatment of Simple Anal Fistula

Anal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03595839
• Other study ID #: mansoura60
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: October 2018
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 1, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Procedure:
• Fistulotomy
The fistula track is laid open after complete probing till the internal opening
• Marsupialization
The laid open track will be marsupialized using interrupted absorbable sutures

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete healing	The duration of time required to achieve complete wound healing	8 weeks