Gastrointestinal Stimulation As a Treatment of Postoperative Ileus Following Extensive Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gastric electrical stimulation.
- Who it may be relevant to
- Registry conditions: Postoperative Ileus, Bowel Paralysis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
GaStrointestinal STIMULation As a Treatment of Postoperative IlEus Following Extensive Surgery (STIMULATE). -A Prospective Double-blinded Randomized Controlled Trial
Overview
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
- Device Gastric electrical stimulation
Mounting of a temporary gastric pacemaker
Primary outcome measures
- Time from surgery till first stool [Time frame: Approx. 7 days]
Secondary outcome measures (8)
- Whole gut and regional transit times [Time frame: Day of surgery til passage of SmartPill (or loss of battery ) approx. +5 days]
- Length of hospital stay [Time frame: approx 14 days]
- Medical complications [Time frame: approx 14 days]
- Surgical complications including anastomotic leakage [Time frame: approx 14 days]
- Need for surgical or radiological interventions [Time frame: approx 14 days]
- Re-hospitalization within 30 days [Time frame: From day of surgery + 30 days]
- Time till initiation of postoperative systemic adjuvant chemotherapy, if indicated [Time frame: From day of surgery +90 days]
- 90-day mortality [Time frame: From day of surgery +90 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Denmark · 1 center
- Aarhus University Hospital — Aarhus
Identifiers
NCT: NCT05752071 · The Stimulate Study