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Gastrointestinal Stimulation as a Treatment of Postoperative Ileus Following Extensive Surgery (STIMULATE)

Primary Purpose

Postoperative Ileus, Bowel Paralysis

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Gastric electric pacemaker
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Ileus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Pre-existent or creation of a stoma 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

Sites / Locations

  • Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Time from surgery till first stool
Daily patient diary information regarding stool and flatus

Secondary Outcome Measures

Whole gut and regional transit times
Measured with the SmartPill
Length of hospital stay
Number of days from primary surgery to hospital discharge
Medical complications
Any cerebral, cardiac, pulmonary, infectious, urogenital and thromboembolic complications
Surgical complications including anastomotic leakage
Surgical complications include bleeding, fascia dehiscence, mechanical ileus, surgical site infection, intraabdominal infection, anastomotic leakage
Need for surgical or radiological interventions
The number of times and the surgical or radiological procedure performed
Re-hospitalization within 30 days
The number of re-hospitalizations and the cause of re-hospitalizations within 30 days og primary surgery
Time till initiation of postoperative systemic adjuvant chemotherapy, if indicated
In patients where indicated, the number of days fra surgery till initiation og systemic adjuvant chemotherapy
90-day mortality
Mortality within 90 days of primary surgery

Full Information

First Posted
February 8, 2023
Last Updated
May 9, 2023
Sponsor
University of Aarhus
Collaborators
Danish Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT05752071
Brief Title
Gastrointestinal Stimulation as a Treatment of Postoperative Ileus Following Extensive Surgery
Acronym
STIMULATE
Official Title
GaStrointestinal sTIMULation As a Treatment of Postoperative ilEus Following Extensive Surgery (STIMULATE). -A Prospective Double-blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Danish Cancer Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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 turned off (control group). Furthermore, the patients are asked to ingest a SmartPill capsule two hours prior to surgery. This will transmit information on gastrointestinal transit times and motility. After surgery, patients will be asked to fill out a diary on bowel movements once a day.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus, Bowel Paralysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
A pace lead is mounted on the stomach, and exteriorized trough the skin and connected to an external pacemaker. The pacemaker is turned off.
Intervention Type
Device
Intervention Name(s)
Gastric electric pacemaker
Intervention Description
Mounting of a temporary gastric pacemaker
Primary Outcome Measure Information:
Title
Time from surgery till first stool
Description
Daily patient diary information regarding stool and flatus
Time Frame
Approx. 7 days
Secondary Outcome Measure Information:
Title
Whole gut and regional transit times
Description
Measured with the SmartPill
Time Frame
Day of surgery til passage of SmartPill (or loss of battery ) approx. +5 days
Title
Length of hospital stay
Description
Number of days from primary surgery to hospital discharge
Time Frame
approx 14 days
Title
Medical complications
Description
Any cerebral, cardiac, pulmonary, infectious, urogenital and thromboembolic complications
Time Frame
approx 14 days
Title
Surgical complications including anastomotic leakage
Description
Surgical complications include bleeding, fascia dehiscence, mechanical ileus, surgical site infection, intraabdominal infection, anastomotic leakage
Time Frame
approx 14 days
Title
Need for surgical or radiological interventions
Description
The number of times and the surgical or radiological procedure performed
Time Frame
approx 14 days
Title
Re-hospitalization within 30 days
Description
The number of re-hospitalizations and the cause of re-hospitalizations within 30 days og primary surgery
Time Frame
From day of surgery + 30 days
Title
Time till initiation of postoperative systemic adjuvant chemotherapy, if indicated
Description
In patients where indicated, the number of days fra surgery till initiation og systemic adjuvant chemotherapy
Time Frame
From day of surgery +90 days
Title
90-day mortality
Description
Mortality within 90 days of primary surgery
Time Frame
From day of surgery +90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 Pre-existent or creation of a stoma 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne K Martensen, MD
Phone
+45 30595095
Email
anmate@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonas Funder, MD, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Martensen, MD

12. IPD Sharing Statement

Learn more about this trial

Gastrointestinal Stimulation as a Treatment of Postoperative Ileus Following Extensive Surgery

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