NCT03424447

Brief Summary

The purpose of the study is to determine the impact of the efferent loop stimulation of a loop ileostomy prior to closure on postoperative complications such as ileus and hospital stay

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
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

November 20, 2014

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

February 7, 2018

Status Verified

January 1, 2018

Enrollment Period

3.6 years

First QC Date

January 31, 2018

Last Update Submit

January 31, 2018

Conditions

Ileostomy - StomaIleostomy; ComplicationsStoma IleostomyIleus Paralytic

Outcome Measures

Primary Outcomes (2)

  • postoperative ileus

    Need for a nasogastric tube

    during the admission for the ileostomy closure

  • bowel movement

    day of hospital stay whe stool or flatus begins

    during the admission for the ileostomy closure

Secondary Outcomes (1)

  • hospital stay

    during the admission for the ileostomy closure

Study Arms (2)

Non stimulated

NO INTERVENTION

Prospective data obtained from non stimulated patients

Stimulated

EXPERIMENTAL

Prospective data obtaied from stimulated patients

Procedure: efferent limb stimulation

Interventions

efferent limb stimulationPROCEDURE
Stimulated

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with loop ileostomy
  • Barium transit throught the efferent limb without leaks

You may not qualify if:

  • Chemotherapy at the moment
  • Ileostomy closure at the same admission than the ileostomy creation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Basurto

Bilbao, Vizcaya, 48002, Spain

RECRUITING

MeSH Terms

Conditions

Ileus

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Alba Vázquez-Melero

    general surgeon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alba Vázquez-Melero

CONTACT

albav6@hotmail.com

Alberto Loizate

CONTACT

alberto.loizatetotoricaguena@osakidetza.eus

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Ambispective cohort study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgeon

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 7, 2018

Study Start

November 20, 2014

Primary Completion

June 30, 2018

Study Completion

October 30, 2018

Last Updated

February 7, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)