Bowel Paralysis, Postoperative Ileus
Conditions
Keywords
Stimulation, Postoperative ileus
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 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.
Interventions
Mounting of a temporary gastric pacemaker
Sponsors
Danish Cancer Society
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from surgery till first stool | Approx. 7 days | Daily patient diary information regarding stool and flatus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Whole gut and regional transit times | Day of surgery til passage of SmartPill (or loss of battery ) approx. +5 days | Measured with the SmartPill |
| 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 |
| Need for surgical or radiological interventions | approx 14 days | The number of times and the surgical or radiological procedure performed |
Countries
Denmark
Contacts
Primary ContactAnne K Martensen, MD
Outcome results
None listed