Postoperative IleusSTIMULATENCT05752071
Gastrointestinal Stimulation As a Treatment of Postoperative Ileus Following Extensive Surgery
A study testing Gastric electrical stimulation in people with Postoperative Ileus and Bowel Paralysis, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus, Bowel Paralysis
- What is being tested?
- Gastric electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Anne Martensen, MD
About this study
Official title: GaStrointestinal STIMULation As a Treatment of Postoperative IlEus Following Extensive Surgery (STIMULATE). -A Prospective Double-blinded Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Postoperative Ileus, Bowel Paralysis
- Being tested
- Gastric electrical stimulation
- Keywords
- Stimulation, Postoperative ileus
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric electrical stimulationDevice
Mounting of a temporary gastric pacemaker
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Gastric electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from surgery till first stool
Daily patient diary information regarding stool and flatus
Measured: Approx. 7 days
Secondary outcomes (8)
Whole gut and regional transit times
Measured with the SmartPill
Measured: Day of surgery til passage of SmartPill (or loss of battery ) approx. +5 days
Length of hospital stay
Number of days from primary surgery to hospital discharge
Measured: approx 14 days
Medical complications
Any cerebral, cardiac, pulmonary, infectious, urogenital and thromboembolic complications
Measured: approx 14 days
Surgical complications including anastomotic leakage
Surgical complications include bleeding, fascia dehiscence, mechanical ileus, surgical site infection, intraabdominal infection, anastomotic leakage
Measured: approx 14 days
Need for surgical or radiological interventions
The number of times and the surgical or radiological procedure performed
Measured: approx 14 days
Re-hospitalization within 30 days
The number of re-hospitalizations and the cause of re-hospitalizations within 30 days og primary surgery
Measured: From day of surgery + 30 days
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
Measured: From day of surgery +90 days
90-day mortality
Mortality within 90 days of primary surgery
Measured: From day of surgery +90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Apr 2023
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Sponsor
- Investigators
- Jonas Funder, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752071
- Sponsor's protocol ID
- The Stimulate Study
- Acronym
- STIMULATE
- Status last verified
- Jan 2025
- First submitted
- 8 Feb 2023
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GaStrointestinal STIMULation As a Treatment of Postoperative IlEus Following Extensive Surgery (STIMULATE). -A Prospective Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05752071
- Acronym / sponsor ID
- STIMULATE / The Stimulate Study
- Conditions
- Postoperative Ileus, Bowel Paralysis
- Keywords
- Stimulation, Postoperative ileus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Gastric electrical stimulationA 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. |
| Control group | Sham comparator | Device: Gastric electrical stimulationA pace lead is mounted on the stomach, and exteriorized trough the skin and connected to an external pacemaker. The pacemaker is turned off. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric electrical stimulationMounting of a temporary gastric pacemaker | Device | Control group, Treatment group |
Primary outcome
Time from surgery till first stool
Time frame: Approx. 7 days
Daily patient diary information regarding stool and flatus
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonas Funder, MD, PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric electrical stimulation in people with Postoperative Ileus and Bowel Paralysis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne K Martensen, MD (+45 30595095, anmate@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from surgery till first stool (time frame: Approx. 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.