Safety of an Early Discharge Protocol After Sleeve Gastrectomy

Not Applicable

• Conditions: Morbid Obesity; Sleeve Gastrectomy; Early Discharge; Safety Issues
• Interventions: Other: Conventional protocol; Other: Early discharge

• Registration Number: NCT03070457
• Lead Sponsor: Hospital Universitari de Bellvitge

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

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-24
• Study First Submitted QC: 2017-02-28
• Last Update Submitted: 2017-02-28
• Study Start: 2017-03-01
• Study First Posted: 2017-03-03
• Last Update Posted: 2017-03-03
• Primary Completion: 2018-12-31
• Study Completion: 2019-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional discharge	Conventional protocol	Patients with conventional protocol and 48-72 hours of hospital stay
Early discharge group	Early discharge	Patients with a shorter hospital stay, 23 hours after surgery

Primary Outcome Measures

Name	Time	Method
Readmissions rate	1 month	No hospital admissions after surgery

Secondary Outcome Measures

Name	Time	Method
Morbidity rate	1 month	Number of postoperative complications
Chronogram for complications after surgery	1 month	Detailed timing of appearance
Quality of life	1 month	BAROS questionnaire
Patients agreement to the protocol	1 month	Specific survey created ad hoc

Trial Locations

Locations (1)

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain