Comparison of Fissurectomy to Fissurectomy With Anoplasty
- Conditions
- Fissure Rectal
- Registration Number
- NCT04911023
- Lead Sponsor
- Fondation Hôpital Saint-Joseph
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 226
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
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
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
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
Search for predictive factors of failure of each technique Day 15 Uni- and multivariate analyses to identify risk factors for failure for each technique
Trial Locations
- Locations (1)
Groupe Hospitalier Paris Saint Joseph
🇫🇷Paris, Ile-de-France, France