Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05752071

Gastrointestinal Stimulation As a Treatment of Postoperative Ileus Following Extensive Surgery

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Postoperative Ileus Bowel Paralysis Digestive System Diseases Gastrointestinal Diseases Ileus Intestinal Diseases Intestinal Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location status: Recruiting

Location contact

Anne Martensen, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastric Electrical Stimulation

Device

Mounting of a temporary gastric pacemaker

Primary outcomes

  1. Time from surgery till first stool

    Time frame: Approx. 7 days

    Daily patient diary information regarding stool and flatus

Secondary outcomes

  1. Whole gut and regional transit times

    Time frame: Day of surgery til passage of SmartPill (or loss of battery ) approx. +5 days

    Measured with the SmartPill

  2. Length of hospital stay

    Time frame: approx 14 days

    Number of days from primary surgery to hospital discharge

  3. Medical complications

    Time frame: approx 14 days

    Any cerebral, cardiac, pulmonary, infectious, urogenital and thromboembolic complications

  4. Surgical complications including anastomotic leakage

    Time frame: approx 14 days

    Surgical complications include bleeding, fascia dehiscence, mechanical ileus, surgical site infection, intraabdominal infection, anastomotic leakage

  5. Need for surgical or radiological interventions

    Time frame: approx 14 days

    The number of times and the surgical or radiological procedure performed

  6. Re-hospitalization within 30 days

    Time frame: From day of surgery + 30 days

    The number of re-hospitalizations and the cause of re-hospitalizations within 30 days og primary surgery

  7. Time till initiation of postoperative systemic adjuvant chemotherapy, if indicated

    Time frame: From day of surgery +90 days

    In patients where indicated, the number of days fra surgery till initiation og systemic adjuvant chemotherapy

  8. 90-day mortality

    Time frame: From day of surgery +90 days

    Mortality within 90 days of primary surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Anne K Martensen, MD

CONTACT

[email protected]

+45 30595095

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Danish Cancer Society

Registry information

Official study title

GaStrointestinal STIMULation As a Treatment of Postoperative IlEus Following Extensive Surgery (STIMULATE). -A Prospective Double-blinded Randomized Controlled Trial

Acronym: STIMULATE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 2, 2023
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.