Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure

Anal Fissure Clinical Trial

Official title:

Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426449
• Other study ID #: mansourau45
• Status: Completed
• Phase: N/A
• First received: February 2, 2018
• Last updated: February 7, 2018
• Start date: January 1, 2015
• Est. completion date: January 1, 2018

Study information

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

Clinical Trial Summary

The present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock with posterolateral internal sphincterotomy at 5 o'clock in regards healing time, postoperative recurrence and complications, particularly fecal incontinence.

Description:

The present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock with posterolateral internal sphincterotomy at 5 o'clock in regards healing time, postoperative recurrence and complications, particularly fecal incontinence. We hypothesized that performing internal sphincterotomy in a point midway between the standard lateral position and the posterior midline position would confer better healing and relief of symptoms with less incidence of fecal incontinence while avoiding the development of keyhole deformity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 1, 2018
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult patients of both genders with chronic posterior anal fissure were included to the study.

Exclusion Criteria:

• Patients with anterior or lateral anal fissure,

• patients with previous anal surgery,

• patients with concomitant anorectal pathology,

• patients with secondary anal fissure due to Crohn's disease or other specific etiology,

• patients with any degree of fecal incontinence,

• patients with active anorectal sepsis.

Related Conditions & MeSH terms

• Anal Fissure
• Fissure in Ano

Intervention

Procedure:
• posterolateral sphincterotomy
Fissurectomy and limited division of internal anal sphincter at 5 o'clock position for 8-10 mm
• lateral sphincterotomy
Fissurectomy and limited division of internal anal sphincter at 3 o'clock position for 8-10 mm

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	Duration of healing	The time to complete healing of anal wound defined by complete epithelization of the wound	6-8 weeks after surgery
Secondary	Anal pain	Degree of postoperative pain assessed by pain visual analogue scale ranging from 0-10 where 0 indicates no pain and 10 indicates the worst possible pain	1-6 weeks after surgery