Subcutaneous Electrical Stimulation in the Prevention of... | NCT02399605

Studies
Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus

NCT02399605

Sponsor

Hospital General Universitario Elche

Status

Unknown status

Last Update Posted

Mar 26, 2015Estimated

Enrollment

500Estimated

Phase

Not Applicable

Conditions

Ileus

Interventions

Stimulation

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Mar 2015Actual

Completion Date

Jun 2015Estimated

First Submitted Date

Mar 10, 2015

First Submission Date that Met QC Criteria

Mar 21, 2015

First Posted Date

Mar 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2015

Last Update Posted Date

Mar 26, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	No intervention, group control.
Stimulation	Experimental	Subcutaneous Electrical Intervention	Other: Stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stimulation	Other	Subcutaneous abdominal electrical stimulation	Stimulation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pedro Moya, PhD	HGU ELCHE	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pedro Moya		Elche	Spain		Spain
Pedro Moya

Condition Browse Module

MeSH Terms

ID	Term
D045823	Ileus

Ancestor Terms

ID	Term
D007415	Intestinal Obstruction
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided