Actively Recruiting
Gastrointestinal Stimulation As a Treatment of Postoperative Ileus Following Extensive Surgery
Led by University of Aarhus · Updated on 2025-01-31
100
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
D
Danish Cancer Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gastrointestinal Stimulation As a Treatment of Postoperative Ileus Following Extensive Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients planned for elective cytoreductive surgery with or without heated intraperitoneal chemotherapy due to colorectal or appendiceal cancer, peritoneal metastases, or pseudomyxoma peritonei
- Provided written and oral informed consent
- Age over 18 years
You will not qualify if you...
- Previous upper gastric or esophageal resection
- History of swallowing difficulties or gastrointestinal narrowing
- Having an implanted or portable electrical medical device such as a pacemaker, defibrillator, or infusion pump
- Pregnant or breastfeeding women
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Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
Research Team
A
Anne K Martensen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
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