Gastrointestinal Stimulation As a Treatment of Postoperative Ileus Following Extensive Surgery

Recruiting now · Not applicable

Conditions studied: Postoperative Ileus, Bowel Paralysis

In brief

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.

Key facts

Study ID

NCT05752071

Run by

University of Aarhus

People needed

100

Starts

2023-04-01

Expected to finish

2027-09-01

Last updated by the study team

2025-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Aarhus University Hospital — Aarhus, Denmark (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.