An interventional study of Gastric electrical stimulation in Postoperative Ileus and Bowel Paralysis, sponsored by University of Aarhus. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-31.
Sponsored by University of Aarhus · Not applicable, Interventional, and Prevention
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.
126 studies on the registry are indexed under Ileus; 13 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 108 interventional studies indexed under Ileus.
Browse Ileus studies →University of Aarhus is the lead sponsor of 1,299 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 electrical stimulation
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 electrical stimulation
Mounting of a temporary gastric pacemaker
Time from surgery till first stool
Daily patient diary information regarding stool and flatus
Time frame: Approx. 7 days
Whole gut and regional transit times
Measured with the SmartPill
Time frame: 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
Time frame: approx 14 days
Medical complications
Any cerebral, cardiac, pulmonary, infectious, urogenital and thromboembolic complications
Time frame: approx 14 days
Surgical complications including anastomotic leakage
Surgical complications include bleeding, fascia dehiscence, mechanical ileus, surgical site infection, intraabdominal infection, anastomotic leakage
Time frame: approx 14 days
Need for surgical or radiological interventions
The number of times and the surgical or radiological procedure performed
Time frame: 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
Time frame: 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
Time frame: From day of surgery +90 days
90-day mortality
Mortality within 90 days of primary surgery
Time frame: From day of surgery +90 days
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.