Actively Recruiting
Gastrointestinal Stimulation As a Treatment of Postoperative Ileus Following Extensive Surgery A Prospective Double-blinded Randomized Controlled Trial
Led by University of Aarhus · Updated on 2025-01-31
100
Participants Needed
1
Research Sites
13 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
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
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
- Written and orally informed consent
- Age 18 years or older
You will not qualify if you...
- Previous upper gastric or esophageal resection
- History of swallowing difficulties or gastrointestinal stenosis
- Implanted or portable electrical medical device such as cardiac pacemaker, defibrillator, or infusion pump
- Pregnant or breastfeeding women
- Not willing or able to provide informed consent if applicable to exclusion based on consent status in source (not explicitly stated but implied exclusion if no consent provided; omitted here as source only states inclusion for consent)
- None other explicitly stated in source beyond above criteria (no explicit mention of unwillingness to consent as exclusion, so omitted here). Thus only the four criteria listed above are included here as exclusion criteria per source text, no additional items added.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 7 days
Participants undergo elective cytoreductive surgery and have a temporary gastric pacemaker lead mounted on the stomach, which is connected to an external pacemaker. The pacemaker is either turned on or off depending on group assignment.
Hospital stay visits during post-operative period
Duration - Up to 14 days
Participants are monitored for recovery, complications, and gut transit times following surgery and device implantation.
Regular hospital visits during recovery period
Duration - Up to 90 days post surgery
Participants are followed for re-hospitalization, initiation of postoperative chemotherapy if indicated, and 90-day mortality outcomes.
Follow-up visits or contacts as needed within 90 days post surgery
Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
Research Team
A
Anne K Martensen, MD
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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