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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
100
Mounting of a temporary gastric pacemaker
Aarhus University Hospital
Aarhus, Denmark
RECRUITINGTime 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
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