Gastrointestinal Stimulation As a Treatment of Postoperative Ileus Following Extensive Surgery
NCT ID: NCT05752071
Last Updated: 2025-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-04-01
2027-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
QUADRUPLE
Study Groups
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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.
Gastric electrical stimulation
Mounting of a temporary gastric pacemaker
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.
Gastric electrical stimulation
Mounting of a temporary gastric pacemaker
Interventions
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Gastric electrical stimulation
Mounting of a temporary gastric pacemaker
Eligibility Criteria
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Inclusion Criteria
* Written and orally informed consent
* Over 18 years of age
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Danish Cancer Society
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Jonas Funder, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Anne Martensen, MD
Role: primary
Other Identifiers
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The Stimulate Study
Identifier Type: -
Identifier Source: org_study_id
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