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Completed

NCT Number: NCT04911023

Comparison of Fissurectomy to Fissurectomy With Anoplasty

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Compare the effectiveness of the two techniques on the disappearance of pain related to anal fissure

    Time frame: Day 15

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

Secondary outcomes

  1. Compare the two techniques for the rate of complications

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Day 15

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

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: ANOFIS

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jun 2, 2021
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.