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Surgical Treatment of a Chronic Anal Fissure (STCAF)

Primary Purpose

Chronic Anal Fissure

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
lateral subcutaneous sphincterotomy
Sponsored by
State Scientific Centre of Coloproctology, Russian Federation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Anal Fissure

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SSCCRussiaRecruiting
  • Nikolay GoloktionovRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

main group

control group

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
Non-Healing Wound
Frequency of post-operative wound epithelialization
Profilometry /sphincterometry findings
Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry
Temporary disability
Duration of temporary disability
Relap
Frequency of relapses

Full Information

First Posted
September 7, 2021
Last Updated
November 3, 2021
Sponsor
State Scientific Centre of Coloproctology, Russian Federation
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1. Study Identification

Unique Protocol Identification Number
NCT05117697
Brief Title
Surgical Treatment of a Chronic Anal Fissure
Acronym
STCAF
Official Title
Treatment of Chronic Anal Fissure by Performing a Lateral Subcutaneous Sphincterotomy.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State Scientific Centre of Coloproctology, Russian Federation

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
main group
Arm Type
Experimental
Arm Description
Patients of the main group are treated with a crack by performing a lateral subcutaneous sphincterotomy.
Arm Title
control group
Arm Type
Experimental
Arm Description
In the control group, the fissure is excised in combination with a lateral subcutaneous sphincterotomy.
Intervention Type
Other
Intervention Name(s)
lateral subcutaneous sphincterotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anal sphincter insufficiency
Description
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).
Time Frame
Up to 60 days
Secondary Outcome Measure Information:
Title
2-item pain intensity (P2)
Description
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).
Time Frame
On day 7, 30 and 60
Title
Non-Healing Wound
Description
Frequency of post-operative wound epithelialization
Time Frame
On day 60
Title
Profilometry /sphincterometry findings
Description
Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry
Time Frame
On day 30 and 60
Title
Temporary disability
Description
Duration of temporary disability
Time Frame
Up to 60 days
Title
Relap
Description
Frequency of relapses
Time Frame
Up to 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
SSCCRussia
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey A Frolov, phd
Phone
+79039689739
Ext
89039689739
Email
DrZharkow@mail.ru
First Name & Middle Initial & Last Name & Degree
Evgeny E Zharkov
Phone
89039689739
Ext
89039689739
Email
drzharkov@mail.ru
Facility Name
Nikolay Goloktionov
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolay 123423 Goloktionov, 1
Phone
+79154835433
Ext
+79154835433
Email
kolagolok1121995@mail.ru

12. IPD Sharing Statement

Plan to Share IPD
No

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Surgical Treatment of a Chronic Anal Fissure

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