NCT01403883Unknown不适用
Impact of Psychological and Enterostomal Therapy Care for Patient Undergoing Rectal Cancer Resection With a Temporary Stoma. Monocentric Randomized Study
Association de Recherche Experimentale et Clinique en Chirurgie Digestive2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Evolution of Psychological anxiety score (STAI/Beck)
研究概览
简要总结
In case of rectal cancer surgery, temporary stoma is recommended to decrease the risk of postoperative anastomotic leakage. The aim of the study was to assess the benefit of an optimal care, i.e., both psychological and enterostomal therapy care.
详细描述
The aim of the study is to asses the benefit of an optimal and specific care concerning the temporary stoma in patients operated for rectal cancer surgery in term of psychological and enterostomal therapy effect.
This study is a monocentric and randomized trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 y
- •Rectal adenocarcinoma (tumor height < 15 cm from the anal verge) with or without pre operative radiochemotherapy.
- •Open or laparoscopic rectal excision with partial or total meso rectal excision with sphincter preservation by colo rectal or colo anal anastomosis.
- •Temporary stoma.
- •Patient consent
- •Patient with national health affiliation
排除标准
- •Stage IV disease with synchronous hepatic or pulmonary metastases
- •Colonic cancer > 16 cm
- •Associated surgical procedure (Hepatic resection, small bowel resection subtotal colectomy)
- •Abdominal perineal resection
- •Associated comorbidity
- •Emergency surgery
- •Psychological care refusal
结局指标
主要结局
Evolution of Psychological anxiety score (STAI/Beck)
时间窗: at Day-45, Day0, Day45, Day60, Day90
Evolution of Global Quality of life (SF36)
时间窗: at Day45, Day0, Day45, Day60, Day90
次要结局
- Evolution of Specific stoma score and stoma care learning(at Day-45, Day0, Day45, Day60, Day90)
- Hospital stay(at Day90)
- Overall morbidity(at Day45, Day60, Day90)
- Specific stoma related morbidity(at Day45, Day60, Day90)
研究者
研究点 (2)
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