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Gastrointestinal Stimulation As a Treatment of Postoperative Ileus Following Extensive Surgery

NCT05752071 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-01-31

No results posted yet for this 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.

Conditions

  • Postoperative Ileus
  • Bowel Paralysis

Interventions

DEVICE

Gastric electrical stimulation

Mounting of a temporary gastric pacemaker

Sponsors & Collaborators

  • Danish Cancer Society

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Jonas Funder, MD, PhD · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2027-06-30
Completion
2027-09-30
FDA Device
Yes

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05752071 on ClinicalTrials.gov