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Comparison of Fissurectomy to Fissurectomy With Anoplasty

Comparison of Fissurectomy to Fissurectomy With Anoplasty

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04911023
Acronym
ANOFIS
Enrollment
226
Registered
2021-06-02
Start date
2021-05-06
Completion date
2022-10-05
Last updated
2023-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fissure Rectal

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.

Interventions

None listed

Sponsors

Fondation Hôpital Saint-Joseph
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Compare the effectiveness of the two techniques on the disappearance of pain related to anal fissureDay 15Difference between the 2 groups in terms of percent of patients free of pain at Day 15 postoperatively

Secondary

MeasureTime frameDescription
Compare the two techniques for the rate of complicationsDay 15Difference between the 2 groups of patients at Day 15 post-operative in terms of complication rate
Compare the two techniques for the healing rateDay 15Difference between the 2 groups of patients at Day 15 post-operative in terms of healing rate
Compare the two techniques for the rate of non-healingDay 15Difference between the 2 groups of patients at Day 15 post-operative in terms of non-healing rate
Compare the two techniques for the recurrence rateDay 15Difference between the 2 groups of patients at Day 15 post-operative in terms of revision rate
Compare the two techniques for the rate of revision surgeryDay 15Difference between the 2 groups of patients at D15 postoperatively in terms of revision rate
Search for predictive factors of failure of each techniqueDay 15Uni- and multivariate analyses to identify risk factors for failure for each technique

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026