Safety of an Early Discharge Protocol After Sleeve Gastrectomy

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03070457
• Other study ID #: AC007/17
• Status: Not yet recruiting
• Phase: N/A
• First received: February 24, 2017
• Last updated: February 28, 2017
• Start date: March 1, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: February 2017
• Source: Hospital Universitari de Bellvitge
• Contact: Amador Garcia Ruiz de Gordejuela, MD, PhD
• Phone: +35932607621
• Email: agrgordejuela[@]bellvitgehospital.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Discharge
• Morbid Obesity
• Obesity, Morbid
• Safety Issues
• Sleeve Gastrectomy

Intervention

Other:
• Early discharge
Patients randomised to early discharge or not
• Conventional protocol
Discharge as usually done 48-72 hours after surgery

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readmissions rate	No hospital admissions after surgery	1 month
Secondary	Morbidity rate	Number of postoperative complications	1 month
Secondary	Chronogram for complications after surgery	Detailed timing of appearance	1 month
Secondary	Quality of life	BAROS questionnaire	1 month
Secondary	Patients agreement to the protocol	Specific survey created ad hoc	1 month