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

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

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 turned off (control group).

Furthermore, the patients are asked to ingest a SmartPill capsule two hours prior to surgery. This will transmit information on gastrointestinal transit times and motility.

After surgery, patients will be asked to fill out a diary on bowel movements once a day.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Ileus; Bowel Paralysis
• Intervention / Treatment: Device: Gastric electric pacemaker

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne K Martensen, MD; Phone Number: +45 30595095; Email: anmate@rm.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: Anne Martensen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; 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.	Device: Gastric electric pacemaker; Mounting of a temporary gastric pacemaker
Sham Comparator: Control group; A pace lead is mounted on the stomach, and exteriorized trough the skin and connected to an external pacemaker. The pacemaker is turned off.	Device: Gastric electric pacemaker; Mounting of a temporary gastric pacemaker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from surgery till first stool	Daily patient diary information regarding stool and flatus	Approx. 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole gut and regional transit times	Measured with the SmartPill	Day of surgery til passage of SmartPill (or loss of battery ) approx. +5 days
Length of hospital stay	Number of days from primary surgery to hospital discharge	approx 14 days
Medical complications	Any cerebral, cardiac, pulmonary, infectious, urogenital and thromboembolic complications	approx 14 days
Surgical complications including anastomotic leakage	Surgical complications include bleeding, fascia dehiscence, mechanical ileus, surgical site infection, intraabdominal infection, anastomotic leakage	approx 14 days
Need for surgical or radiological interventions	The number of times and the surgical or radiological procedure performed	approx 14 days
Re-hospitalization within 30 days	The number of re-hospitalizations and the cause of re-hospitalizations within 30 days og primary surgery	From day of surgery + 30 days
Time till initiation of postoperative systemic adjuvant chemotherapy, if indicated	In patients where indicated, the number of days fra surgery till initiation og systemic adjuvant chemotherapy	From day of surgery +90 days
90-day mortality	Mortality within 90 days of primary surgery	From day of surgery +90 days

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Danish Cancer Society
• Investigators: Principal Investigator: Jonas Funder, MD, PhD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Paralysis; Ileus
• Other Study ID Numbers: The Stimulate Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes