Surgical Treatment of a Chronic Anal Fissure

NCT05117697 | Unknown DMC

• 1 other identifier: 56IG701SSCC977
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

This study is aimed at studying the effectiveness and safety of surgical treatment of chronic anal fissure.

Conditions

Chronic Anal Fissure

Outcome Measures

Primary Outcomes (1)

• Anal sphincter insufficiency

  Frequency of anal sphincter insufficiency according to the Wexner scale incontinence after the surgical intervention. Self reported daily meausure outcome, wich evaluate from 0 - to 20 points (where 0 points = full feacal continence; 20 points = full feacal incontinence).

  Up to 60 days

Secondary Outcomes (5)

• 2-item pain intensity (P2)

  On day 7, 30 and 60

• Non-Healing Wound

  On day 60

• Profilometry /sphincterometry findings

  On day 30 and 60

• Temporary disability

  Up to 60 days

• Relap

  Up to 60 days

Study Arms (2)

main group

EXPERIMENTAL

Patients of the main group are treated with a crack by performing a lateral subcutaneous sphincterotomy.

Other: lateral subcutaneous sphincterotomy

control group

EXPERIMENTAL

In the control group, the fissure is excised in combination with a lateral subcutaneous sphincterotomy.

Other: lateral subcutaneous sphincterotomy

Interventions

lateral subcutaneous sphincterotomy OTHER

Patients of the main group are treated with a crack by performing a lateral subcutaneous sphincterotomy. In the control group, the fissure is excised in combination with a lateral subcutaneous sphincterotomy.

control group; main group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic anal fissure

You may not qualify if:

• Inflammatory diseases of the colon
• Pectenosis
• Previous surgical interventions on the anal canal
• IV grade internal and external hemorrhoids
• Rectal fistula
• Severe somatic diseases at the decompensation stage
• Pregnancy and lactation
• Anal sphincter insufficiency

Sponsors & Collaborators

• State Scientific Centre of Coloproctology, Russian Federation: lead

Study Sites (2)

SSCCRussia

Moscow, 123423, Russia

RECRUITING

Nikolay Goloktionov

Moscow, Russia

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Parallel Assignment A comparative,randomized, prospective, single-center clinical study. Patients of the main group are treated with a crack by performing a lateral subcutaneous sphincterotomy. In the control group, the fissure is excised in combination with a lateral subcutaneous sphincterotomy.

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: November 11, 2021
• Study Start: November 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2023
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)