Comparing a Randomised Controlled Intervention With Observational Data.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10,992
- 主要终点
- severe postoperative complications within 30 days
研究概览
简要总结
Comparison of participants in a randomised controlled trial (RCT) with observational data from patients operated in Sweden during the same period of time. The primary objective is to compare effects from a complex surgical intervention from RCT and observational data.
详细描述
Randomised controlled trials (RCT) are "golden standard" for assessing interventions in medical science. Due to ethical or practical reasons, RCTs may however not always be feasible. The study objective was to test if the results from the RCT differ from observational data in a setting with a complex surgical intervention.
Using the Scandinavian Obesity Surgery Registry database we intend to compare patients operated with laparoscopic gastric bypass surgery within a register based RCT from May 1st 2010 until Nov 14th 2011, with all patients operated with the same procedure registered in the database during the same period of time.
Primary end-point measures are severe complications within 30 days (safety outcome) and surgery for small bowel obstruction (efficacy outcome) within 4 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The same as acceptance criteria for bariatric surgery according to the 1991 NIH Consensus Statement
排除标准
- •retrocolic gastric bypass procedure
- •previous bariatric procedures
- •primary open procedures
- •missing data on handling of the mesenteric defects
研究组 & 干预措施
RCT
patients operated with laparoscopic gastric bypass surgery within a register based RCT from May 1st 2010 until Nov 14th 2011.
1:1 randomization to closure of mesenteric defects by running, non-absorbable sutures
干预措施: closure of mesenteric defects (Procedure)
RCT
patients operated with laparoscopic gastric bypass surgery within a register based RCT from May 1st 2010 until Nov 14th 2011.
1:1 randomization to closure of mesenteric defects by running, non-absorbable sutures
干预措施: non-closure of mesenteric defects (Procedure)
non-RCT
patients operated with laparoscopic gastric bypass surgery outside of the RCT from May 1st 2010 until Nov 14th 2011.
Intervention of mesenteric defects according to local tradition or choice of surgeon (non-randomized)
干预措施: closure of mesenteric defects (Procedure)
non-RCT
patients operated with laparoscopic gastric bypass surgery outside of the RCT from May 1st 2010 until Nov 14th 2011.
Intervention of mesenteric defects according to local tradition or choice of surgeon (non-randomized)
干预措施: non-closure of mesenteric defects (Procedure)
结局指标
主要结局
severe postoperative complications within 30 days
时间窗: 30 days
Specified as Clavien-Dindo grade 3b or more
reoperation for small bowel obstruction
时间窗: 4 years
Efficacy outcome: Number of participants with reoperation due to small bowel obstruction defined as acute symptoms of bowel obstruction with findings suggestive of small bowel obstruction during surgery
次要结局
- length of the operation(intraoperative)
- postoperative length of stay(30 days)
- specific postoperative complications(30 days)
- weight-loss at 2 years after surgery(2 years)
研究者
Erik Stenberg, MD
DR
Region Örebro County