NCT02399605

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

Same day

First QC Date

March 10, 2015

Last Update Submit

March 21, 2015

Conditions

Ileus

Outcome Measures

Primary Outcomes (1)

  • Time to first flatus

    Participants will be followed for the duration of hospital stay, an expected average of 5 days

Study Arms (2)

Control

NO INTERVENTION

No intervention, group control.

Stimulation

EXPERIMENTAL

Subcutaneous Electrical Intervention

Other: Stimulation

Interventions

StimulationOTHER

Subcutaneous abdominal electrical stimulation

Stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing colorectal surgery.
  • Signing informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pedro Moya

Elche, Spain, Spain

Location

Pedro Moya

Alicante, 03203, Spain

Location

MeSH Terms

Conditions

Ileus

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Pedro Moya, PhD

    HGU ELCHE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 26, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2015

Study Completion

June 1, 2015

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

ES(2)