Comparison of Fissurectomy to Fissurectomy With Anoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Compare the effectiveness of the two techniques on the disappearance of pain related to anal fissure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Compare the effectiveness of the two techniques on the disappearance of pain related to anal fissure
时间窗: Day 15
Difference between the 2 groups in terms of percent of patients free of pain at Day 15 postoperatively
次要结局
- Compare the two techniques for the rate of complications(Day 15)
- Compare the two techniques for the healing rate(Day 15)
- Compare the two techniques for the rate of non-healing(Day 15)
- Compare the two techniques for the recurrence rate(Day 15)
- Compare the two techniques for the rate of revision surgery(Day 15)
- Search for predictive factors of failure of each technique(Day 15)