Gastrointestinal stimulation to treat bowel paralysis after major surgery
GaStrointestinal STIMULation As a Treatment of Postoperative IlEus Following Extensive Surgery (STIMULATE). -A Prospective Double-blinded Randomized Controlled Trial
This study tests if using a pacemaker to stimulate the gut can help patients recover their bowel function faster after major abdominal surgery for certain cancers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT05752071 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of gastrointestinal stimulation with a pacemaker to reduce the duration of postoperative ileus in patients undergoing major abdominal surgery for metastatic colorectal cancer, appendiceal cancer, or pseudomyxoma peritonei. Participants will receive either active stimulation or a control treatment during their recovery. The study aims to determine if stimulating the gastrointestinal tract can lead to faster bowel recovery post-surgery. Patients will track their bowel movements daily to assess the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for elective cytoreductive surgery for colorectal or appendiceal cancer with peritoneal metastases.
Not a fit: Patients with previous upper gastric or esophageal resections or those with implanted electrical medical devices will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce recovery time and improve outcomes for patients after major abdominal surgeries.
How similar studies have performed: While gastrointestinal stimulation has been explored in other contexts, this specific application for postoperative ileus is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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: * 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
Where this trial is running
Aarhus
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
Study contacts
- Principal investigator: Jonas Funder, MD, PhD — Aarhus University Hospital
- Study coordinator: Anne K Martensen, MD
- Email: anmate@rm.dk
- Phone: +45 30595095
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.