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Study of Gastric Electrical Stimulation to Reduce Postoperative Bowel Paralysis After Major Abdominal Surgery for Colorectal and Related Cancers
Led by University of Aarhus · Updated on 2025-01-31
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the effect of gastrointestinal stimulation using a temporary pacemaker to reduce the length of postoperative bowel paralysis in patients undergoing major abdominal surgery for metastasizing colorectal cancer, appendiceal cancer, or pseudomyxoma peritonei. The trial aims to determine if stimulating the gastrointestinal tract with this device shortens the time patients experience postoperative ileus after surgery. All participants will receive cytoreductive surgery with or without heated intraperitoneal chemotherapy, which is the standard treatment for these cancers. During surgery, a pacing lead will be attached to the stomach and connected to an external pacemaker through the abdominal wall. In the experimental group, the pacemaker is turned on with specific settings, while in the control group it remains off. After surgery, the pacemaker and lead are removed once normal bowel function returns. Participants will track their bowel movements daily in a diary after surgery. Researchers will measure the time from surgery until the first stool as the primary outcome, along with secondary outcomes including gut transit times, length of hospital stay, complications, need for further interventions, rehospitalization within 30 days, timing of postoperative chemotherapy if needed, and 90-day mortality. The study includes follow-up for approximately 90 days to monitor these outcomes.
CONDITIONS
Brief Title
Gastrointestinal Stimulation As a Treatment of Postoperative Ileus Following Extensive Surgery
Research Team
A
Anne K Martensen, MD
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