Comparison of Fissurectomy to Fissurectomy With Anoplasty

NCT ID: NCT04911023

Last Updated: 2023-04-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 226 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2022-10-05

Brief Summary

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.

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.

Conditions

Fissure Rectal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients operated by fissurectomy

No interventions assigned to this group

Patients operated by fissurectomy with anoplasty

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, France

Countries

France

References

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 Oct;160(5):330-336. doi: 10.1016/j.jviscsurg.2023.03.003. Epub 2023 Mar 25.

Reference Type: RESULT

PMID: 36973105 (View on PubMed)

Other Identifiers

ANOFIS

Identifier Type: -

Identifier Source: org_study_id