Norwegian Stoma Trial - Open-label, Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 18
- 主要终点
- Surgical complications graded as Accordion grade 3 or more
研究概览
简要总结
The Norwegian Stoma Trial is an open-label multicenter trial investigating the use of stomas, both diveriting and permanent, in the surgical treatment of rectal cancer. The objective is to compare the chosen strategy to surgical complications, health realted quality of life and length of stay.
详细描述
In this national, multicenter study the study group will investigate whether patients with rectal adenocarcinoma undergoing a resection with an anastomosis will benefit from a diverting stoma or not, by studying how choice of surgery affects complications. In addition the study group will investigate complication rates and HRQoL among patients receiving a permanent colostomy and compare this to patients who have received an anastomosis. The investigators know that there are different approaches to the use of stomas (both permanent and diverting) between different hospitals. The investigators aim to discover potential differences in complication rates, length of stay and HRQoL among these patients and compare this to the chosen strategy. Health related quality of life will be measured using the EORTC CR 29 and EORTC CR 30 questionnares. Bowel function will also be monitored using the LARS (low anterior resection syndrome) score.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Verified rectal adenocarcinoma by biopsy
- •Tumor located in the rectum with lower border of the tumor located 15 cm or less from the anal verge.
- •Given informed consent
排除标准
- •Advanced tumor stage requiring exenterative surgery beyond a convetional APR or TME.
- •Stage IV disease
- •Synchronous colon cancer necessitating a total colectomy
- •Other concomitant disease(s) which will complicate participation.
- •Unwillingness to give informed consent
结局指标
主要结局
Surgical complications graded as Accordion grade 3 or more
时间窗: Measured one year after the primary surgery
The study group will investigate whether patients undergoing rectal resection with an anastomosis with a diverting stoma will have higher complication rates compared to patients who do not recieve a diverting stoma.
次要结局
- Total length of hospital stay(Measured one year after the primary surgery)
- Bowel function measured by the Low Anterior Resection Syndrome (LARS) score(One year after the primary surgery)
- Surgical complications graded as Accordion grade 3 or more(Measured one year after the primary surgery)
- Generic health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) C30 questionnaire(One year after the primary surgery)
- Generic health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) C30 questionnaire.(One year after the primary surgery)
- Disease specific health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) CR29 questionnnaire(One year after the primary surgery)
- Disease specific health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) CR29 questionnnaire.(One year after the primary surgery)
研究者
Lars Thomas
Principal Investigator
The Hospital of Vestfold