Pseudo Continent Perineal Colostomy vs Permanent Left Iliac Colostomy After Abdominoperineal Resection for Ultra Low Rectal Adenocarcinoma: Comparaison of Out of Pocket Costs, Hospital Bills and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Cost of management of both stoma types
研究概览
简要总结
Aim of this study is to compare the cost-effectiveness and the quality of life in the 6 months following the surgery of a pseudo continent perineal colostomy (PCPC) and a permanent left iliac colostomy (PLIC) following an abdominoperineal resection (APR) for ultra low rectal cancer
详细描述
The surgical treatment of ultra low rectal adenocarcinoma has known great changes, yet the abdominoperineal resection (APR) is still indicated in over 20% of these cases.
A permanent left abdominal stoma is the standard salvage technique.
The pseudo continent perineal colostomy (PCPC) is an alternative technique especially in low income countries where the stoma bag and stoma care is not covered by health insurances.
Furthermore, this technique allows the conservation of body image, which is frequently requested by muslim patients whenever it is possible.
The aim of this study is to compare the cost effectiveness of both techniques as well as the quality of life of patients in the 6 first months following the surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients of 18 years old or above
- •Abdominoperineal resection for ultra low rectal cancer
- •Creation of a definitive iliac colostomy or a pseudo continent perineal colostomy
- •Patients willing to participate to this study (writting consent)
排除标准
- •Patients unable to respond to the Quality Of Life questionnaires
结局指标
主要结局
Cost of management of both stoma types
时间窗: 180 days from surgery
defined by out of pocket costs during the first 6 months following the surgery in euros
Globcal Quality of life of patients with PCPC and PLIC
时间窗: 180 days from surgery
using the EORTC C30 Quality Of Life questionnaires
Specific Quality of life of patients with PCPC and PLIC
时间窗: 180 days from surgery
using the EORTC CR29 Quality Of Life questionnaires
Costs of hospital stay
时间窗: 180 days from surgery
defined as Out of pocket hospital bills in euros for all of the admission and the readmissions for surgical complication management
次要结局
- 90 day morbidity and mortality rate(90 days from surgery)
研究者
Amine Souadka
professor
Moroccan Society of Surgery