NCT05752071

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Apr 2023Sep 2027

First Submitted

Initial submission to the registry

February 8, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

4.2 years

First QC Date

February 8, 2023

Last Update Submit

January 28, 2025

Conditions

Postoperative IleusBowel Paralysis

Keywords

StimulationPostoperative ileus

Outcome Measures

Primary Outcomes (1)

  • Time from surgery till first stool

    Daily patient diary information regarding stool and flatus

    Approx. 7 days

Secondary Outcomes (8)

  • Whole gut and regional transit times

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

  • Length of hospital stay

    approx 14 days

  • Medical complications

    approx 14 days

  • Surgical complications including anastomotic leakage

    approx 14 days

  • Need for surgical or radiological interventions

    approx 14 days

  • +3 more secondary outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL

A pace lead is mounted on the stomach, and exteriorized trough the skin and connected to an external pacemaker. The pacemaker is set to the following settings: 10,5 Volt, 14 hz, 330 Micro sec, Cycling 5 seconds off 0,1 sec on. The pacemaker is turned on.

Device: Gastric electrical stimulation

Control group

SHAM COMPARATOR

A pace lead is mounted on the stomach, and exteriorized trough the skin and connected to an external pacemaker. The pacemaker is turned off.

Device: Gastric electrical stimulation

Interventions

Gastric electrical stimulationDEVICE

Mounting of a temporary gastric pacemaker

Control groupTreatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Ileus

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Jonas Funder, MD, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne K Martensen, MD

CONTACT

+45 30595095anmate@rm.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2023

First Posted

March 2, 2023

Study Start

April 1, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

January 31, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)