Gastrointestinal Stimulation as a Treatment of Postoperative Ileus Following Extensive Surgery

Postoperative Ileus Clinical Trial

— STIMULATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05752071
• Other study ID #: The Stimulate Study
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: September 2026

Study information

• Verified date: April 2024
• Source: University of Aarhus
• Contact: Anne K Martensen, MD
• Phone: +45 30595095
• Email: anmate[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ileus
• Paralysis
• Postoperative Ileus

Intervention

Device:
• Gastric electric pacemaker
Mounting of a temporary gastric pacemaker

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from surgery till first stool	Daily patient diary information regarding stool and flatus	Approx. 7 days
Secondary	Whole gut and regional transit times	Measured with the SmartPill	Day of surgery til passage of SmartPill (or loss of battery ) approx. +5 days
Secondary	Length of hospital stay	Number of days from primary surgery to hospital discharge	approx 14 days
Secondary	Medical complications	Any cerebral, cardiac, pulmonary, infectious, urogenital and thromboembolic complications	approx 14 days
Secondary	Surgical complications including anastomotic leakage	Surgical complications include bleeding, fascia dehiscence, mechanical ileus, surgical site infection, intraabdominal infection, anastomotic leakage	approx 14 days
Secondary	Need for surgical or radiological interventions	The number of times and the surgical or radiological procedure performed	approx 14 days
Secondary	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
Secondary	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
Secondary	90-day mortality	Mortality within 90 days of primary surgery	From day of surgery +90 days