Safety of an Early Discharge Protocol After Sleeve Gastre... | NCT03070457

Studies
Safety of an Early Discharge Protocol After Sleeve Gastrectomy

NCT03070457

Sponsor

Hospital Universitari de Bellvitge

Status

Unknown status

Last Update Posted

Mar 3, 2017Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Morbid Obesity
Sleeve Gastrectomy
Early Discharge
Safety Issues

Interventions

Early discharge
Conventional protocol

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

Feb 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2017Estimated

Primary Completion Date

Dec 31, 2018Estimated

Completion Date

Mar 31, 2019Estimated

First Submitted Date

Feb 24, 2017

First Submission Date that Met QC Criteria

Feb 28, 2017

First Posted Date

Mar 3, 2017Actual

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

Feb 28, 2017

Last Update Posted Date

Mar 3, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amador Garci-a Ruiz de Gordejuela, MD, PhD, Hospital Universitari de BellvitgePrincipal Investigator

Lead Sponsor

Hospital Universitari de BellvitgeOTHER

Collaborators

Not provided

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

Evaluate the safety and efficacy of an early discharge protocol (23 hours, overnight stay) after scheduled sleeve gastrectomy.

Detailed Description

This study aims to demonstrate that a shorter hospital stay after sleeve gastrectomy is as safe and useful as conventional protocol with 48-36 hours of stay. We consider that an adequate patient information and support will facilitate this shorter stay

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Early discharge group	Experimental	Patients with a shorter hospital stay, 23 hours after surgery	Other: Early discharge
Conventional discharge	Active Comparator	Patients with conventional protocol and 48-72 hours of hospital stay	Other: Conventional protocol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early discharge	Other	Patients randomised to early discharge or not	Early discharge group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Readmissions rate	No hospital admissions after surgery	1 month

Secondary Outcomes

Measure	Description	Time Frame
Morbidity rate	Number of postoperative complications	1 month
Chronogram for complications after surgery	Detailed timing of appearance

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients eligible for Sleeve gastrectomy
BMI 35 to 50
ASA I to III
Conventional address close to our Hospital
Laparoscopic surgery
Accompanying person after discharge
Availability for a smart phone

Exclusion Criteria:

ASA IV
Revisional Surgery
Conversion to laparotomy
ICU Admission after surgery
Insulin dependent Diabetes Mellitus
Surgery finishing after 3 pm

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amador Garcia Ruiz de Gordejuela, MD, PhD	Contact	+35932607621		agrgordejuela@bellvitgehospital.cat

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitari de Bellvitge		L'Hospitalet de Llobregat	Barcelona	08907	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided