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ANOFIS: Comparison of Fissurectomy to Fissurectomy With Anoplasty

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04911023
Collaborator
(none)
226
Enrollment
1
Location
19.8
Anticipated Duration (Months)
11.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    226 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Comparison of Fissurectomy to Fissurectomy With Anoplasty
    Actual Study Start Date :
    May 6, 2021
    Actual Primary Completion Date :
    Aug 6, 2021
    Anticipated Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Patients operated by fissurectomy
    Patients operated by fissurectomy with anoplasty

    Outcome Measures

    Primary Outcome Measures

    1. Compare the effectiveness of the two techniques on the disappearance of pain related to anal fissure [Day 15]

      Difference between the 2 groups in terms of percent of patients free of pain at Day 15 postoperatively

    Secondary Outcome Measures

    1. Compare the two techniques for the rate of complications [Day 15]

      Difference between the 2 groups of patients at Day 15 post-operative in terms of complication rate

    2. Compare the two techniques for the healing rate [Day 15]

      Difference between the 2 groups of patients at Day 15 post-operative in terms of healing rate

    3. Compare the two techniques for the rate of non-healing [Day 15]

      Difference between the 2 groups of patients at Day 15 post-operative in terms of non-healing rate

    4. Compare the two techniques for the recurrence rate [Day 15]

      Difference between the 2 groups of patients at Day 15 post-operative in terms of revision rate

    5. Compare the two techniques for the rate of revision surgery [Day 15]

      Difference between the 2 groups of patients at D15 postoperatively in terms of revision rate

    6. Search for predictive factors of failure of each technique [Day 15]

      Uni- and multivariate analyses to identify risk factors for failure for each technique

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France France 75014

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT04911023
    Other Study ID Numbers:
    • ANOFIS
    First Posted:
    Jun 2, 2021
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 30, 2022