NCT03070457

Brief Summary

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

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

February 24, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

February 24, 2017

Last Update Submit

February 28, 2017

Conditions

Morbid ObesitySleeve GastrectomyEarly DischargeSafety Issues

Keywords

bariatric surgerysleeve gastrectomyeras

Outcome Measures

Primary Outcomes (1)

  • Readmissions rate

    No hospital admissions after surgery

    1 month

Secondary Outcomes (4)

  • Morbidity rate

    1 month

  • Chronogram for complications after surgery

    1 month

  • Quality of life

    1 month

  • Patients agreement to the protocol

    1 month

Study Arms (2)

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

Early dischargeOTHER

Patients randomised to early discharge or not

Early discharge group
Conventional protocolOTHER

Discharge as usually done 48-72 hours after surgery

Conventional discharge

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Amador Garcia Ruiz de Gordejuela, MD, PhD

CONTACT

+35932607621agrgordejuela@bellvitgehospital.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 24, 2017

First Posted

March 3, 2017

Study Start

March 1, 2017

Primary Completion

December 31, 2018

Study Completion

March 31, 2019

Last Updated

March 3, 2017

Record last verified: 2017-02

Locations

ES(1)