Safety of an Early Discharge Protocol After Sleeve Gastrectomy

Safety of an Early Discharge Protocol After Sleeve Gastrectomy. Randomised Clinical Trial

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

Study Overview

• Status: Unknown
• Conditions: Morbid Obesity; Safety Issues; Sleeve Gastrectomy; Early Discharge
• Intervention / Treatment: Other: Early discharge; Other: Conventional protocol

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amador Garcia Ruiz de Gordejuela, MD, PhD; Phone Number: +35932607621; Email: agrgordejuela@bellvitgehospital.cat

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early discharge group; Patients with a shorter hospital stay, 23 hours after surgery	Other: Early discharge; Patients randomised to early discharge or not
Active Comparator: Conventional discharge; Patients with conventional protocol and 48-72 hours of hospital stay	Other: Conventional protocol; Discharge as usually done 48-72 hours after surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): March 31, 2019

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: bariatric surgery; sleeve gastrectomy; eras
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: AC007/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No