Gastrointestinal Stimulation As a Treatment of Postoperative Ileus Following Extensive Surgery

Last updated: January 28, 2025
Sponsor: University of Aarhus
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ileus

Cataplexy

Treatment

Gastric electrical stimulation

Gastric electric pacemaker

Clinical Study ID

NCT05752071
The Stimulate Study
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Patients planned for elective cytoreductive surgery with or without heatedintraperitoneal chemotherapy due to either colorectal or appendiceal cancer or withperitoneal metastases or due to pseudomyxoma peritonei

  • Written and orally informed consent

  • Over 18 years of age

Exclusion

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

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Gastric electrical stimulation
Phase:
Study Start date:
April 01, 2023
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Aarhus University Hospital

    Aarhus, 8200
    Denmark

    Active - Recruiting

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