Overview

This trial is active, not recruiting.

Condition ileus
Treatment stimulation
Sponsor Hospital General Universitario Elche
Start date March 2015
End date March 2015
Trial size 500 participants
Trial identifier NCT02399605, Cirugia1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(No Intervention)
No intervention, group control.
(Experimental)
Subcutaneous Electrical Intervention
stimulation
Subcutaneous abdominal electrical stimulation

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus in Colorectal Surgery
Principal investigator Pedro Moya, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Hospital General Universitario Elche.