NCT01881594

Brief Summary

The aim of this study is to compare postoperative ileus between stimulated and unstimulated patients prior to ileostomy closure.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Status
completed

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

January 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

8 months

First QC Date

April 29, 2013

Last Update Submit

June 17, 2013

Conditions

Ileostomy; Complications

Keywords

ileostomy closure,postoperative ileus,stimulation ileostomy

Outcome Measures

Primary Outcomes (1)

  • postoperative ileus

    within the first days after surgery

Study Arms (2)

No stimulation

ACTIVE COMPARATOR

unstimulated patients prior to surgery,ileostomy closure surgery without prior stimulation of efferent limb.

Procedure: Procedure/Surgery

Stimulation

EXPERIMENTAL

stimulation of the efferent limb of the ileostomy prior to ileostomy closure.

Procedure: Procedure/Surgery

Interventions

Procedure/SurgeryPROCEDURE

daily stimulation of efferent loop prior to surgery (ileostomy closure)

Also known as: Stimulation
No stimulationStimulation

Eligibility Criteria

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

You may qualify if:

  • protective ileostomy after rectal cancer surgery

You may not qualify if:

  • under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Abrisqueta J, Abellan I, Lujan J, Hernandez Q, Parrilla P. Stimulation of the efferent limb before ileostomy closure: a randomized clinical trial. Dis Colon Rectum. 2014 Dec;57(12):1391-6. doi: 10.1097/DCR.0000000000000237.

    PMID: 25380005DERIVED

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Section chief. Coloproctology department.

Study Record Dates

First Submitted

April 29, 2013

First Posted

June 19, 2013

Study Start

January 1, 2012

Primary Completion

September 1, 2012

Last Updated

June 19, 2013

Record last verified: 2013-06