Gastrointestinal Stimulation As a Treatment of Postoperative Ileus Following Extensive Surgery

Not Applicable

Recruiting

• Conditions: Bowel Paralysis; Postoperative Ileus
• Interventions: Device: Gastric electric pacemaker

• Registration Number: NCT05752071
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-21
• Study First Posted: 2023-03-02
• Study Start: 2023-04-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-31
• Primary Completion: 2027-06
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Gastric electric pacemaker	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.
Control group	Gastric electric pacemaker	A pace lead is mounted on the stomach, and exteriorized trough the skin and connected to an external pacemaker. The pacemaker is turned off.

Primary Outcome Measures

Name	Time	Method
Time from surgery till first stool	Approx. 7 days	Daily patient diary information regarding stool and flatus

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark