Gastrointestinal Stimulation As a Treatment of Postoperative Ileus Following Extensive Surgery (STIMULATE)

University of Aarhus

Status: Enrolling

Conditions: Bowel Paralysis; Postoperative Ileus

Treatments: Device: Gastric electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05752071

The Stimulate Study

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Treatment group

Experimental group

Description:

A pace lead is mounted on the stomach, and exteriorized trough the skin and connected to an external pacemaker. The pacemaker is set to the following settings: 10,5 Volt, 14 hz, 330 Micro sec, Cycling 5 seconds off 0,1 sec on. The pacemaker is turned on.

Treatment:

Device: Gastric electrical stimulation

Control group

Sham Comparator group

Description:

A pace lead is mounted on the stomach, and exteriorized trough the skin and connected to an external pacemaker. The pacemaker is turned off.

Treatment:

Device: Gastric electrical stimulation