GaStrointestinal STIMULation As a Treatment of Postoperative IlEus Following Extensive Surgery (STIMULATE). -A Prospective Double-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Time from surgery till first stool
研究概览
简要总结
The goal of this clinical trial is to investigate the effect of gastrointestinal stimulation with a pacemaker on the length of postoperative bowel paralysis in patients undergoing major abdominal surgery due to metastasizing colorectal cancer, appendiceal cancer or pseudomyxoma peritonei.
The main question it aims to answer is if the length of postoperative ileus is reduced when the gastrointestinal tract is stimulated with a pacemaker.
All participants will undergo cytoreductive surgery +/- heated intraperitoneal chemotherapy (the standard treatment for colorectal cancer, appendiceal cancer with peritoneal carcinomatosis or pseudomyxoma peritonei). After surgery, but before the abdomen is closed a pace lead will be attached to the stomach, exteriorized trough the abdominal wall and connected to an external pacemaker. The pacemaker is either turned on (experimental group) or off (control group).
After surgery, patients will be asked to fill out a diary on bowel movements once a day. Once normal bowel function is regained, the pace lead and pacemaker will be removed trough the abdominal wall with a firm pull.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 planned for elective cytoreductive surgery with or without heated intraperitoneal chemotherapy due to either colorectal or appendiceal cancer or with peritoneal metastases or due to pseudomyxoma peritonei
- •Written and orally informed consent
- •Over 18 years of age
排除标准
- •Previous upper gastric or esophageal resection
- •History of difficulties in swallowing or gastrointestinal stenosis
- •Implanted or portable electrical medical device e.g. cardiac pacemaker, defibrillator or infusion pump etc.
- •Pregnant or breast-feeding women
结局指标
主要结局
Time from surgery till first stool
时间窗: Approx. 7 days
Daily patient diary information regarding stool and flatus
次要结局
- Surgical complications including anastomotic leakage(approx 14 days)
- 90-day mortality(From day of surgery +90 days)
- Whole gut and regional transit times(Day of surgery til passage of SmartPill (or loss of battery ) approx. +5 days)
- Need for surgical or radiological interventions(approx 14 days)
- Re-hospitalization within 30 days(From day of surgery + 30 days)
- Time till initiation of postoperative systemic adjuvant chemotherapy, if indicated(From day of surgery +90 days)
- Length of hospital stay(approx 14 days)
- Medical complications(approx 14 days)