Observational Prospective Study of a Non-cross-linked Porcine Acellular Dermal Matrix in Ventral Mesh Rectopexy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 3
- 主要终点
- Rate of adverse events including reoperation and removal of the mesh
研究概览
简要总结
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Rectopexy membrane used in rectal prolapse repair by ventral rectopexy and to identify emerging risks in comparison to the clinical data related to other types of fixation material.
The present study will be a prospective multicentric non-randomized and non-controlled trial involving 55 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.
详细描述
The study will be prospective, multicentric, single-arm, observational (non-interventional) to evaluate the safety and performance of CELLIS Rectopexy used in rectal prolapse repair by ventral rectopexy.
All evaluations will be performed and products used according to the usual practice, without additional or unusual diagnostic, treatment and monitoring procedure.
The study will be conducted in France in 3 investigational centres including 55 patients scheduled for the repair of rectal prolapse.
Each patient will participate in one assessment period including a screening visit, followed by the day of surgical procedure and a hospitalization period. Patients will return for ambulatory visits at Day 30 (+/- 7 days), Month 6 (+/- 2 weeks), Month 12 (+/- 2 weeks) and Month 24 (+/-2 weeks).
The surgical technique used to repair rectal prolapse will be either Laparoscopic Ventral Rectopexy (LVR) or a robotic assisted rectopexy with the use of the da Vinci Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patient aged ≥18 years,
- •Patient with an indication of rectal prolapse repair by ventral rectopexy (external and internal rectal prolapse),
- •Patient being informed of its participation to the study and of the follow-up visits, and having no objection to the clinical data collection and medical file access,
- •Patient being informed of the porcine origin of the device in advance of the procedure.
排除标准
- •Patient with known hypersensitivity to porcine materials,
- •Patient with an existing infection not appropriately treated,
- •Patient who are pregnant,
- •Patient having refused to participate to the study,
- •Patient refusing to come back to the follow-up visits.
结局指标
主要结局
Rate of adverse events including reoperation and removal of the mesh
时间窗: From the surgical procedure through the entire 24-month follow-up period
Percentage
次要结局
- Rate of structural defect recurrence based on rectal examination with/without adjunctive investigations as clinically indicated(Throughout the study until end of the 24-month follow-up period)
- Symptoms severity scored by a visual analog scale (0-10; 0 corresponding to no impact on life and 10 corresponding to extreme, incapacitating impact)(At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits)
- Severity of disease by the use of the Cleveland Clinic Incontinence Score (CCIS)(At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits)
- Severity of disease by the use of the Obstructed Defecation Score (ODS)(At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits)
- Quality of life by the use of the Short Form (36) Health Survey (SF-36) questionnaire(At baseline and at 24-month)
- Description of device deficiency: inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labelling.(During the surgical procedure)
- Rate of structural defect recurrence requiring reoperation(Throughout the study until end of the 24-month follow-up period)
- Symptoms evolution: presence or absence of symptoms (constipation, fecal incontinence, bloody and/or mucous rectal discharge (soiling), unsatisfactory sexual activity, pain)(At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits)
- Rate of symptoms recurrence(Throughout the study until end of the 24-month follow-up period)