RecruitingNot ApplicableNCT05752071

Gastrointestinal Stimulation As a Treatment of Postoperative Ileus Following Extensive Surgery

GaStrointestinal STIMULation As a Treatment of Postoperative IlEus Following Extensive Surgery (STIMULATE). -A Prospective Double-blinded Randomized Controlled Trial


Sponsor

University of Aarhus

Enrollment

100 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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

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Interventions

DEVICEGastric electrical stimulation

Mounting of a temporary gastric pacemaker


Locations(1)

Aarhus University Hospital

Aarhus, Denmark

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NCT05752071


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