IleusSESPINCT02399605
Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus
A study testing Stimulation in people with Ileus, run by Hospital General Universitario Elche at 2 sites in Spain.
Trial summary
Assess whether the application of electrical stimulation in patients undergoing subcutaneous colon cancer in a Multimodal Rehabilitation Program (Fast track) decreases the incidence of postoperative ileus, improving the results of morbidity and mortality, hospitalization and health care costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileus
- What is being tested?
- Stimulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesSpain
- Study dates
- Mar 2015to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 undergoing colorectal surgery.
- Signing informed consent.
Who cannot join
- Patients with no oral nutrition (dysphagia, esophageal stricture, pyloric stenosis)
- Patients with contraindications for electrical stimulation.
- Psychiatric Disorders
- HIV
- Pregnant or breastfeeding
- intestinal obstruction
Show all 9Show fewer
- uncontrolled infection
- ASA IV
- No acceptance or failure to follow protocol multimodal rehabilitation.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus in Colorectal Surgery
Assess whether the application of electrical stimulation in patients undergoing subcutaneous colon cancer in a Multimodal Rehabilitation Program (Fast track) decreases the incidence of postoperative ileus, improving the results of morbidity and mortality, hospitalization and health care costs.
Read the detailed description
Prospective randomized study on the application of subcutaneous abdominal electrical stimulation in the postoperative of colonic surgery and its relationship with the appearance of postoperative ileus.
- Conditions
- Ileus
- Being tested
- Stimulation
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimulationOther
Subcutaneous abdominal electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention, group control. |
| Stimulation | Experimental | Subcutaneous Electrical Intervention Receives: Other: Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first flatus
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2015
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IleusStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Moya, Hospital General Universitario Elche
- Investigators
- Pedro Moya, PhD, Principal investigator, HGU ELCHE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399605
- Sponsor's protocol ID
- Cirugia1
- Acronym
- SESPI
- Status last verified
- Mar 2015
- First submitted
- 10 Mar 2015
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus in Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02399605
- Acronym / sponsor ID
- SESPI / Cirugia1
- Conditions
- Ileus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (estimated)
- First posted
- 26 Mar 2015 (estimated)
- 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.
Assess whether the application of electrical stimulation in patients undergoing subcutaneous colon cancer in a Multimodal Rehabilitation Program (Fast track) decreases the incidence of postoperative ileus, improving the results of morbidity and mortality, hospitalization and health care costs.
Detailed description
Prospective randomized study on the application of subcutaneous abdominal electrical stimulation in the postoperative of colonic surgery and its relationship with the appearance of postoperative ileus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention, group control. |
| Stimulation | Experimental | Other: StimulationSubcutaneous Electrical Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing colorectal surgery.
- Signing informed consent.
Key exclusion criteria (9 listed)
- Patients with no oral nutrition (dysphagia, esophageal stricture, pyloric stenosis)
- Patients with contraindications for electrical stimulation.
- Psychiatric Disorders
- HIV
- Pregnant or breastfeeding
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 |
|---|---|---|
| StimulationSubcutaneous abdominal electrical stimulation | Other | Stimulation |
Primary outcome
Time to first flatus
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
Related trials for Ileus
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
At-Home Bowel Stimulation
Post-Operative Ileus (POI)
Recruiting
The Food Network Effect
Post Operative Patients
RecruitingObservational study
The Effect of Ostomy Care Education Applied With the Teach-Back Method to Ostomy-Opened Individuals on Self-Care Power, Ostomy Adjustment, and Anxiety
Ostomy - Ileostomy or Colostomy, Canser
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. This study is not recruiting at the moment.
Pedro Moya, PhD principal investigator
HGU ELCHE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation in people with Ileus, run by Hospital General Universitario Elche at 2 sites in Spain.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first flatus (time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 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 26 Mar 2015.