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Safety of an Early Discharge Protocol After Sleeve Gastrectomy

C

Catalan Institute of Health

Status

Unknown

Conditions

Sleeve Gastrectomy
Safety Issues
Early Discharge
Morbid Obesity

Treatments

Other: Conventional protocol
Other: Early discharge

Study type

Interventional

Funder types

Other

Identifiers

NCT03070457
AC007/17

Details and patient eligibility

About

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

Full 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

Enrollment

60 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Amador Garcia Ruiz de Gordejuela, MD, PhD

Data sourced from clinicaltrials.gov

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