Outcome of Transanal Minimally Invasive (TAMIS) Mucosal Resection in Patients With Obstructed Defecation Syndrome - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- functional outcome assessment
研究概览
简要总结
Patients, aged 18 - 90 years, undergoing TAMIS mucosectomy at the Department of General Surgery at the Medical University of Vienna are enrolled into our study.
Primary endpoint is the outcome (improvement of ODS symptoms), defined by ODS score.
详细描述
Various surgical approaches for the treatment of obstructed defecation syndrome (ODS) commonly associated with rectocele and rectal intussusception have been investigated in the literature. Methods such as stapled transanal resection of the rectum (STARR) and ventral prosthesis rectopexy (VPR) show promising results at least in the short term. In the long-term, however, the results do not seem convincing. Schiano di Visconte et al. report a recurrence of ODS symptoms in 40 percent of the patients, treated with stapled transanal rectal resection in a 10-year follow up. The clinical outcome of surgical treatment of ODS using transanal minimally invasive surgery (TAMIS) in the sense of a mucosal resection without stapling technique has not yet been investigated. This project is designed to show the short-term outcome of non-stapled mucosal resection through TAMIS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Need of minimal invasive mucosal resection due to obstructed defecation syndrome after several unsuccessful conservative treatments over a period of more than 6 months with presence of an organic cause (Symptomatic intussusception with or without rectocele) in medical examinations (defecography, endoluminal ultrasound, endoanal manometry)
- •Age: 18-90 years
- •Ability and willingness to understand and comply with planned interventions during the study.
- •Voluntarily signed informed consent after a full explanation of the study to the participant.
排除标准
- •Any physical or mental disorder could interfere with the participant's safety during the clinical trial or with the study objectives.
- •Inability to communicate well with the investigator due to language problems or reduced mental development.
- •Inability or unwillingness to give written informed consent.
结局指标
主要结局
functional outcome assessment
时间窗: 6 months
functional outcome defined by ODS score
次要结局
- fecal incontinence assessment(6 months)
- Quality of life assessment(6 months)
研究者
Dr. Christopher Dawoud
Dr. Christopher Dawoud
Medical University of Vienna