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NCT02399605 Clinical Trial

Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus

Ileus Clinical Trial

— SESPI  

Official title:
Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus in Colorectal Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02399605
Other study ID # Cirugia1
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 10, 2015
Last updated March 21, 2015
Start date March 2015
Est. completion date June 2015

Study information
Verified date March 2015
Source Hospital General Universitario Elche
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 500
Est. completion date June 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• Stimulation
Subcutaneous abdominal electrical stimulation

Locations
Country Name City State
Spain Pedro Moya Alicante
Spain Pedro Moya Elche

Sponsors (1)
Lead Sponsor Collaborator
Hospital General Universitario Elche

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to first flatus Participants will be followed for the duration of hospital stay, an expected average of 5 days Yes
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