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

Primary Purpose

Ileus

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Stimulation
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ileus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pedro Moya
  • Pedro Moya

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Stimulation

Arm Description

No intervention, group control.

Subcutaneous Electrical Intervention

Outcomes

Primary Outcome Measures

Time to first flatus

Secondary Outcome Measures

Full Information

First Posted
March 10, 2015
Last Updated
March 21, 2015
Sponsor
Hospital General Universitario Elche
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1. Study Identification

Unique Protocol Identification Number
NCT02399605
Brief Title
Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus
Acronym
SESPI
Official Title
Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus in Colorectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention, group control.
Arm Title
Stimulation
Arm Type
Experimental
Arm Description
Subcutaneous Electrical Intervention
Intervention Type
Other
Intervention Name(s)
Stimulation
Intervention Description
Subcutaneous abdominal electrical stimulation
Primary Outcome Measure Information:
Title
Time to first flatus
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Moya, PhD
Organizational Affiliation
HGU ELCHE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pedro Moya
City
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Pedro Moya
City
Elche
Country
Spain

12. IPD Sharing Statement

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Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus

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