Back to resultsSafety of an Early Discharge Protocol After Sleeve Gastrectomy
Primary Purpose
Morbid Obesity, Sleeve Gastrectomy, Early Discharge
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Early discharge
Conventional protocol
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring bariatric surgery, sleeve gastrectomy, eras
Eligibility Criteria
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
Sites / Locations
- Hospital Universitari de Bellvitge
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early discharge group
Conventional discharge
Arm Description
Patients with a shorter hospital stay, 23 hours after surgery
Patients with conventional protocol and 48-72 hours of hospital stay
Outcomes
Primary Outcome Measures
Readmissions rate
No hospital admissions after surgery
Secondary Outcome Measures
Morbidity rate
Number of postoperative complications
Chronogram for complications after surgery
Detailed timing of appearance
Quality of life
BAROS questionnaire
Patients agreement to the protocol
Specific survey created ad hoc
Full Information
NCT ID
NCT03070457
First Posted
February 24, 2017
Last Updated
February 28, 2017
Sponsor
Hospital Universitari de Bellvitge
1. Study Identification
Unique Protocol Identification Number
NCT03070457
Brief Title
Safety of an Early Discharge Protocol After Sleeve Gastrectomy
Official Title
Safety of an Early Discharge Protocol After Sleeve Gastrectomy. Randomised Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Anticipated)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
March 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari de Bellvitge
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Sleeve Gastrectomy, Early Discharge, Safety Issues
Keywords
bariatric surgery, sleeve gastrectomy, eras
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early discharge group
Arm Type
Experimental
Arm Description
Patients with a shorter hospital stay, 23 hours after surgery
Arm Title
Conventional discharge
Arm Type
Active Comparator
Arm Description
Patients with conventional protocol and 48-72 hours of hospital stay
Intervention Type
Other
Intervention Name(s)
Early discharge
Intervention Description
Patients randomised to early discharge or not
Intervention Type
Other
Intervention Name(s)
Conventional protocol
Intervention Description
Discharge as usually done 48-72 hours after surgery
Primary Outcome Measure Information:
Title
Readmissions rate
Description
No hospital admissions after surgery
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Morbidity rate
Description
Number of postoperative complications
Time Frame
1 month
Title
Chronogram for complications after surgery
Description
Detailed timing of appearance
Time Frame
1 month
Title
Quality of life
Description
BAROS questionnaire
Time Frame
1 month
Title
Patients agreement to the protocol
Description
Specific survey created ad hoc
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amador Garcia Ruiz de Gordejuela, MD, PhD
Phone
+35932607621
Email
agrgordejuela@bellvitgehospital.cat
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Safety of an Early Discharge Protocol After Sleeve Gastrectomy
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