NCT04282473招募中不适用
Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh: Material-epidemiology Study
Centre Hospitalier Universitaire de Nīmes16 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2022年5月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 134
- 试验地点
- 16
- 主要终点
- Rate of parastomal hernia between groups
研究概览
简要总结
This study is a follow-up of the GRECCAR 07 cohort (NCT01380860). Patients will be evaluated 5 years following terminal colostomy to observe patient long-term patient outcomes from colostomy with and without mesh placement.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •The patient must be affiliated with a health insurance programme
- •Patient was included in the GRECCAR 07 cohort (PHRC National 2011; N° RCB: 2011-A01572-39 - ClinicalTrials.gov ID: NCT01380860)
- •Patient received colostomy 5 years ago
排除标准
- •The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
- •The subject signals opposition to participating in the study
- •The patient is under safeguard of justice or state guardianship
- •The patient is pregnant or breastfeeding
结局指标
主要结局
Rate of parastomal hernia between groups
时间窗: 5 years after colostomy formation
Percentage patients with parastomal hernia taken from patient medical records
Date of parastomal hernia
时间窗: 5 years after colostomy formation
Date of parastomal hernia taken from patient records
次要结局
- Protrusion around the stoma(5 years after colostomy formation)
- Patient reported pain(5 years after colostomy formation)
- Incarceration(5 years after colostomy formation)
- Cost of patients care(5 years after colostomy formation)
- Discomfort(5 years after colostomy formation)
- Number of medications taken in each group(5 years after colostomy formation)
- Occlusion(5 years after colostomy formation)
- Patient reported quality of life(5 years after colostomy formation)
- Other associated treatment received by patients in each group(5 years after colostomy formation)
- Rehabilitation sessions undergone by patients in each group(5 years after colostomy formation)
- Sick leave taken by patients in each group(5 years after colostomy formation)
- Pain at colostomy site(5 years after colostomy formation)
- Patient reported satisfaction(5 years after colostomy formation)
- Number of specialist and general consultations attended by patients between groups(5 years after colostomy formation)
研究者
研究点 (16)
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