Gastrointestinal Stimulation as a Treatment of Postoperative Ileus Following Extensive Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Ileus, Bowel Paralysis

Intervention / Treatment
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* Device: Gastric electric pacemaker


Participation Criteria
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Eligibility Criteria
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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 Pre-existent or creation of a stoma 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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 electric pacemaker<br>* Mounting of a temporary gastric pacemaker<br>|
| Sham Comparator: Control group<br>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 electric pacemaker<br>* Mounting of a temporary gastric pacemaker<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from surgery till first stool | Daily patient diary information regarding stool and flatus | Approx. 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole gut and regional transit times | Measured with the SmartPill | 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 | approx 14 days | 
| Medical complications | Any cerebral, cardiac, pulmonary, infectious, urogenital and thromboembolic complications | approx 14 days | 
| Surgical complications including anastomotic leakage | Surgical complications include bleeding, fascia dehiscence, mechanical ileus, surgical site infection, intraabdominal infection, anastomotic leakage | approx 14 days | 
| Need for surgical or radiological interventions | The number of times and the surgical or radiological procedure performed | 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 | 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 | From day of surgery +90 days | 
| 90-day mortality | Mortality within 90 days of primary surgery | From day of surgery +90 days |