Comparison of Fissurectomy to Fissurectomy With Anoplasty (ANOFIS)

Surgery is sometimes necessary to relieve patients with chronic anal fissure. It consists of resecting the edges of the fissure to make a wound larger than the initial fissure, in order to obtain healing. Thus, the edges of the wound do not stick together and the healing is done from the bottom of the wound. This procedure is widely performed in France with results that seem satisfactory. In addition to resection of the fissure, a partial closure of the wound can be associated with a small flap of rectal mucosa which is sutured with a few absorbable stitches: this is anoplasty.

Study Overview

• Status: Completed
• Conditions: Fissure Rectal

Detailed Description

There is some debate as to whether to perform a fissurectomy alone or to complement it with an anoplasty to accelerate healing. The choice of technique performed depends on the training and habits of the operators but the results of fissurectomy alone and fissurectomy with anoplasty have never been compared. In the medical-surgical proctology department of the Groupe Hospitalier Paris Saint-Joseph (GHPSJ), both procedures are performed. The investigators therefore decided to compare the after-effects of fissurectomies alone with those of fissurectomies with anoplasty that were performed in the department in 2019. The choice between the 2 procedures is left exclusively to the discretion of the operator. The criteria for choice between the two patient populations are not different.

• Study Type: Observational
• Enrollment (Actual): 226

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75014
      • Groupe Hospitalier Paris Saint Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected based on procedure coding:

• HKFA004 = Excision of an anal fissure [Anal fissurectomy]
• HKFA005 = Excision of a fissure and/or anal stenosis, with mucosal anoplasty
• HKFA002 = Resection of an infected anal fissure
• HKFA006 = Excision of an anal fissure, with mucosal anoplasty and resection of an isolated hemorrhoidal pack.

The follow-up of the patients corresponds to the usual follow-up of the patients within the proctology unit (consultation at Day 15, Day 30 post-operative and then every month until complete healing).

Description

Inclusion Criteria:

• Major patient
• Patient managed in the proctology department of Groupe hospitalier Paris Saint-Joseph for single posterior idiopathic fissures (anoplasty possible only in the context of non-infected posterior fissure) between January 1 and December 31, 2019 by fissurectomy alone or fissurectomy with anoplasty

Exclusion Criteria:

• anterior or bipolar fissure
• infected fissure
• history of proctological surgery
• Crohn's disease
• HIV infection
• tubercular lesion validated by anatomopathology
• history of pelvic-perineal radiotherapy
• Tumor cells on histology
• fissurectomy +/- anoplasty associated with another proctological surgical procedure
• patient under guardianship or curatorship
• patient deprived of liberty
• patient under court protection
• Patient opposing the use of his data for this research

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients operated by fissurectomy
Patients operated by fissurectomy with anoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the effectiveness of the two techniques on the disappearance of pain related to anal fissure	Difference between the 2 groups in terms of percent of patients free of pain at Day 15 postoperatively	Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the two techniques for the rate of complications	Difference between the 2 groups of patients at Day 15 post-operative in terms of complication rate	Day 15
Compare the two techniques for the healing rate	Difference between the 2 groups of patients at Day 15 post-operative in terms of healing rate	Day 15
Compare the two techniques for the rate of non-healing	Difference between the 2 groups of patients at Day 15 post-operative in terms of non-healing rate	Day 15
Compare the two techniques for the recurrence rate	Difference between the 2 groups of patients at Day 15 post-operative in terms of revision rate	Day 15
Compare the two techniques for the rate of revision surgery	Difference between the 2 groups of patients at D15 postoperatively in terms of revision rate	Day 15
Search for predictive factors of failure of each technique	Uni- and multivariate analyses to identify risk factors for failure for each technique	Day 15

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

General Publications

• Skoufou M, Lefevre JH, Fels A, Fathallah N, Benfredj P, de Parades V. Fissurectomy with mucosal advancement flap anoplasty: The end of a dogma? J Visc Surg. 2023 Mar 25:S1878-7886(23)00043-7. doi: 10.1016/j.jviscsurg.2023.03.003. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Actual): August 6, 2021
• Study Completion (Actual): October 5, 2022

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ANOFIS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No