Gastrointestinal Stimulation As a Treatment of Postoperative Ileus Following Extensive Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this 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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Gastric electrical stimulation
DeviceMounting of a temporary gastric pacemaker
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Treatment groupExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time from surgery till first stool
Daily patient diary information regarding stool and flatus
Time frame
Approx. 7 daysSecondary outcomes
1
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 days2
Length of hospital stay
Number of days from primary surgery to hospital discharge
Time frame
approx 14 days3
Medical complications
Any cerebral, cardiac, pulmonary, infectious, urogenital and thromboembolic complications
Time frame
approx 14 days4
Surgical complications including anastomotic leakage
Surgical complications include bleeding, fascia dehiscence, mechanical ileus, surgical site infection, intraabdominal infection, anastomotic leakage
Time frame
approx 14 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Danish Cancer Society
Collaborator
Source ClinicalTrials.gov