Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus

NCT ID: NCT02399605

Last Updated: 2015-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-06-30

Brief Summary

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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

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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

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Ileus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

No intervention, group control.

Group Type NO_INTERVENTION

No interventions assigned to this group

Stimulation

Subcutaneous Electrical Intervention

Group Type EXPERIMENTAL

Stimulation

Intervention Type OTHER

Subcutaneous abdominal electrical stimulation

Interventions

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Stimulation

Subcutaneous abdominal electrical stimulation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

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Pedro Moya

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pedro Moya, PhD

Role: PRINCIPAL_INVESTIGATOR

HGU ELCHE

Locations

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Pedro Moya

Elche, Spain, Spain

Site Status

Pedro Moya

Alicante, , Spain

Site Status

Countries

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Spain

Other Identifiers

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Cirugia1

Identifier Type: -

Identifier Source: org_study_id

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