Clinical trial NCT05752071: Gastrointestinal Stimulation As a Treatment of Postoperative Ileus Following Extensive Surgery
Official title: GaStrointestinal STIMULation As a Treatment of Postoperative IlEus Following Extensive Surgery (STIMULATE). -A Prospective Double-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Ileus
Bowel Paralysis
Keywords: Stimulation
Postoperative ileus
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2023-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Time from surgery till first stool
timeFrame: Approx. 7 days
Secondary outcomes:
measure: Whole gut and regional transit times
timeFrame: Day of surgery til passage of SmartPill (or loss of battery ) approx. +5 days
measure: Length of hospital stay
timeFrame: approx 14 days
measure: Medical complications
timeFrame: approx 14 days
measure: Surgical complications including anastomotic leakage
timeFrame: approx 14 days
measure: Need for surgical or radiological interventions
timeFrame: approx 14 days
measure: Re-hospitalization within 30 days
timeFrame: From day of surgery + 30 days
measure: Time till initiation of postoperative systemic adjuvant chemotherapy, if indicated
timeFrame: From day of surgery +90 days
measure: 90-day mortality
timeFrame: From day of surgery +90 days
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Jonas Funder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: