STIMULATE: Gastrointestinal Stimulation as a Treatment of Postoperative Ileus Following Extensive Surgery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: Gastric electric pacemaker
Mounting of a temporary gastric pacemaker
|
| Sham Comparator: 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. |
Device: Gastric electric pacemaker
Mounting of a temporary gastric pacemaker
|
Outcome Measures
Primary Outcome Measures
- Time from surgery till first stool [Approx. 7 days]
Daily patient diary information regarding stool and flatus
Secondary Outcome Measures
- Whole gut and regional transit times [Day of surgery til passage of SmartPill (or loss of battery ) approx. +5 days]
Measured with the SmartPill
- Length of hospital stay [approx 14 days]
Number of days from primary surgery to hospital discharge
- Medical complications [approx 14 days]
Any cerebral, cardiac, pulmonary, infectious, urogenital and thromboembolic complications
- Surgical complications including anastomotic leakage [approx 14 days]
Surgical complications include bleeding, fascia dehiscence, mechanical ileus, surgical site infection, intraabdominal infection, anastomotic leakage
- Need for surgical or radiological interventions [approx 14 days]
The number of times and the surgical or radiological procedure performed
- Re-hospitalization within 30 days [From day of surgery + 30 days]
The number of re-hospitalizations and the cause of re-hospitalizations within 30 days og primary surgery
- Time till initiation of postoperative systemic adjuvant chemotherapy, if indicated [From day of surgery +90 days]
In patients where indicated, the number of days fra surgery till initiation og systemic adjuvant chemotherapy
- 90-day mortality [From day of surgery +90 days]
Mortality within 90 days of primary surgery
Eligibility Criteria
Criteria
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:
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Previous upper gastric or esophageal resection
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Pre-existent or creation of a stoma
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History of difficulties in swallowing or gastrointestinal stenosis
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Implanted or portable electrical medical device e.g. cardiac pacemaker, defibrillator or infusion pump etc.
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Pregnant or breast-feeding women
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Aarhus
- Danish Cancer Society
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- The Stimulate Study