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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03070457
Other study ID # AC007/17
Secondary ID
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
Health authority
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

Study Design


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
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