Surgical Treatment of a Chronic Anal Fissure (STCAF)

Treatment of Chronic Anal Fissure by Performing a Lateral Subcutaneous Sphincterotomy.

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Anal Fissure
• Intervention / Treatment: Other: lateral subcutaneous sphincterotomy

Detailed Description

A chronic anal fissure is a rupture of the mucous membrane of the anal canal, lasting more than 2 months and resistant to non-surgical treatment. This condition is accompanied by a strong pain syndrome during and after defecation (defecation). This condition is most often found in young and able-bodied adults, so the issue of treatment is of particular relevance.

The main cause of the development of a chronic anal fissure is a spasm of the internal sphincter. It should be eliminated first of all to ensure effective therapy.The investigators plan to treat a chronic anal fissure by performing a lateral subcutaneous sphincterotomy, without excision of the fissure.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 123423
    • Recruiting
    • SSCCRussia
    • Contact: Sergey A Frolov, phd; Phone Number: 89039689739 +79039689739; Email: DrZharkow@mail.ru
    • Contact: Evgeny E Zharkov; Phone Number: 89039689739 89039689739; Email: drzharkov@mail.ru
  • Moscow, Russian Federation
    • Recruiting
    • Nikolay Goloktionov
    • Contact: Nikolay 123423 Goloktionov, 1; Phone Number: +79154835433 +79154835433; Email: kolagolok1121995@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with chronic anal fissure

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: main group; Patients of the main group are treated with a crack by performing a lateral subcutaneous sphincterotomy.	Other: lateral subcutaneous sphincterotomy; 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.
Experimental: control group; In the control group, the fissure is excised in combination with a lateral subcutaneous sphincterotomy.	Other: lateral subcutaneous sphincterotomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-item pain intensity (P2)	Self reported pain intensity after the defecation and during the day after the surgical intervention. Each item is scored 0-10 (0 = no pain; 10 = pain as bad, as can can be).	On day 7, 30 and 60
Non-Healing Wound	Frequency of post-operative wound epithelialization	On day 60
Profilometry /sphincterometry findings	Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry	On day 30 and 60
Temporary disability	Duration of temporary disability	Up to 60 days
Relap	Frequency of relapses	Up to 60 days

Collaborators and Investigators

• Sponsor: State Scientific Centre of Coloproctology, Russian Federation

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Anus Diseases; Fissure in Ano
• Other Study ID Numbers: 56IG701SSCC977

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No