Postoperative Ileus Clinical Trial
— STIMULATEOfficial title:
GaStrointestinal sTIMULation As a Treatment of Postoperative ilEus Following Extensive Surgery (STIMULATE). -A Prospective Double-blinded Randomized Controlled 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 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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 2026 |
Est. primary completion date | June 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Danish Cancer Society |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time from surgery till first stool | Daily patient diary information regarding stool and flatus | Approx. 7 days | |
Secondary | Whole gut and regional transit times | Measured with the SmartPill | Day of surgery til passage of SmartPill (or loss of battery ) approx. +5 days | |
Secondary | Length of hospital stay | Number of days from primary surgery to hospital discharge | approx 14 days | |
Secondary | Medical complications | Any cerebral, cardiac, pulmonary, infectious, urogenital and thromboembolic complications | approx 14 days | |
Secondary | Surgical complications including anastomotic leakage | Surgical complications include bleeding, fascia dehiscence, mechanical ileus, surgical site infection, intraabdominal infection, anastomotic leakage | approx 14 days | |
Secondary | Need for surgical or radiological interventions | The number of times and the surgical or radiological procedure performed | approx 14 days | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 90-day mortality | Mortality within 90 days of primary surgery | From day of surgery +90 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04205058 -
Coffee After Pancreatic Surgery
|
N/A | |
Completed |
NCT02232893 -
Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy
|
Phase 2 | |
Not yet recruiting |
NCT05001763 -
Prucalopride for Postoperative Ileus in Patients Undergoing Robot-assisted Laparoscopic Radical Cystectomy
|
Phase 2 | |
Active, not recruiting |
NCT04547868 -
Can Coffee/Caffeine Improve Post-Operative Gastrointestinal Recovery
|
N/A | |
Completed |
NCT02815956 -
Tibial Nerve Stimulation and Postoperative Ileus
|
N/A | |
Completed |
NCT02947269 -
Prucalopride in Postoperative Ileus
|
Phase 3 | |
Recruiting |
NCT05512741 -
Intestinal Microbiota and Postoperative Ileus After Colorectal Surgery
|
||
Recruiting |
NCT04675606 -
Implementing a Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies
|
N/A | |
Completed |
NCT02161367 -
Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery
|
Phase 4 | |
Completed |
NCT01956643 -
Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation
|
N/A | |
Completed |
NCT00464425 -
Electroacupuncture for Postoperative Ileus After Laparoscopic Colorectal Surgery
|
Phase 3 | |
Completed |
NCT00402961 -
Trial of Acupuncture for Reduction of Post-Colectomy Ileus
|
Phase 2 | |
Terminated |
NCT04100265 -
ANTERO-5: Gastric Motility in Postoperative Ileus
|
N/A | |
Recruiting |
NCT04090073 -
Electroacupuncture Combined With Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
|
N/A | |
Recruiting |
NCT03222557 -
Electroacupuncture for Postoperative Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer
|
N/A | |
Withdrawn |
NCT02261454 -
RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children
|
N/A | |
Completed |
NCT02004652 -
Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery
|
Phase 2 | |
Completed |
NCT02639728 -
The Effect of Coffee Consumption in Enhancing Recovery of Bowel Function Following Colorectal Surgery.
|
N/A | |
Completed |
NCT00509327 -
Randomized Clinical Trial of Bisacodyl Versus Placebo on Postoperative Bowel Motility in Elective Colorectal Surgery
|
Phase 4 | |
Completed |
NCT03097900 -
Does Caffeine Enhance Bowel Recovery After Colorectal Surgery?
|
Phase 2 |