Stimulation of the Efferent Loop Before Loop Ileostomy Cl... | NCT03424447

Studies
Stimulation of the Efferent Loop Before Loop Ileostomy Closure

NCT03424447

Sponsor

Hospital de Basurto

Status

Unknown status

Last Update Posted

Feb 7, 2018Actual

Enrollment

140Estimated

Phase

Phase 2

Conditions

Ileostomy - Stoma
Ileostomy; Complications
Stoma Ileostomy
Ileus Paralytic

Interventions

efferent limb 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

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2014

Primary Completion Date

Jun 30, 2018Estimated

Completion Date

Oct 30, 2018Estimated

First Submitted Date

Jan 31, 2018

First Submission Date that Met QC Criteria

Jan 31, 2018

First Posted Date

Feb 7, 2018Actual

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

Jan 31, 2018

Last Update Posted Date

Feb 7, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

ALBA VÁZQUEZ-MELERO, General Surgeon, Hospital de BasurtoPrincipal Investigator

Lead Sponsor

Hospital de BasurtoOTHER

Collaborators

Name	Class
Alberto Loizate Totoricaguena	UNKNOWN
Pedro García Alonso	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

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

Detailed Description

Stimulation was performed 3 weeks prior to the ileostomy closure using 500 cc of a thickening substance (saline and nutritional thickener) through the efferent limb.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non stimulated	No Intervention	Prospective data obtained from non stimulated patients
Stimulated	Experimental	Prospective data obtaied from stimulated patients	Procedure: efferent limb stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
efferent limb stimulation	Procedure		Stimulated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
hospital stay	days	during the admission for the ileostomy closure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alba Vázquez-Melero	Contact			albav6@hotmail.com
Alberto Loizate	Contact			alberto.loizatetotoricaguena@osakidetza.eus

Overall Officials

Name	Affiliation	Role
Alba Vázquez-Melero	general surgeon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Basurto	Recruiting	Bilbao	Vizcaya	48002	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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