Safety of an Early Discharge Protocol After Sleeve Gastrectomy

NCT ID: NCT03070457

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-03-31

Brief Summary

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

Detailed Description

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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

Conditions

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Morbid Obesity Sleeve Gastrectomy Early Discharge Safety Issues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early discharge group

Patients with a shorter hospital stay, 23 hours after surgery

Group Type EXPERIMENTAL

Early discharge

Intervention Type OTHER

Patients randomised to early discharge or not

Conventional discharge

Patients with conventional protocol and 48-72 hours of hospital stay

Group Type ACTIVE_COMPARATOR

Conventional protocol

Intervention Type OTHER

Discharge as usually done 48-72 hours after surgery

Interventions

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Early discharge

Patients randomised to early discharge or not

Intervention Type OTHER

Conventional protocol

Discharge as usually done 48-72 hours after surgery

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitari de Bellvitge

OTHER

Sponsor Role lead

Responsible Party

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Amador Garci-a Ruiz de Gordejuela

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Countries

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Spain

Central Contacts

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Amador Garcia Ruiz de Gordejuela, MD, PhD

Role: CONTACT

+35932607621

Other Identifiers

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AC007/17

Identifier Type: -

Identifier Source: org_study_id

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