Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus (SESPI)

March 21, 2015 updated by: Pedro Moya, Hospital General Universitario Elche

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03203
        • Pedro Moya
      • Elche, Spain
        • Pedro Moya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing colorectal surgery.
  • Signing informed consent.

Exclusion Criteria:

  • Patients with no oral nutrition (dysphagia, esophageal stricture, pyloric stenosis)
  • Patients with contraindications for electrical stimulation.
  • Psychiatric Disorders
  • HIV
  • Pregnant or breastfeeding
  • intestinal obstruction
  • uncontrolled infection
  • ASA IV
  • No acceptance or failure to follow protocol multimodal rehabilitation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention, group control.
Experimental: Stimulation
Subcutaneous Electrical Intervention
Other: Stimulation
Subcutaneous abdominal electrical stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first flatus
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Participants will be followed for the duration of hospital stay, an expected average of 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Elche

Investigators

  • Principal Investigator: Pedro Moya, PhD, HGU ELCHE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

March 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

March 21, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 21, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cirugia1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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