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Recruiting Not applicable

Gastrointestinal Stimulation As a Treatment of Postoperative Ileus Following Extensive Surgery

NCT05752071 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2023-04-01
Last updated
2025-01-31

Condition(s) studied

Postoperative IleusBowel Paralysis

Investigational drug(s) / intervention(s)

Gastric electrical stimulation

Gastric electrical stimulation: Mounting of a temporary gastric pacemaker

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Time from surgery till first stool — Approx. 7 days
    Daily patient diary information regarding stool and flatus

Trial sites (1)

FacilityCityRegionStatus
Aarhus University Hospital Aarhus Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05752071 on ClinicalTrials.gov ↗ ← All trials in Denmark