ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety of an Early Discharge Protocol After Sleeve Gastrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03070457
Recruitment Status : Not yet recruiting
First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Amador Garci-a Ruiz de Gordejuela, Hospital Universitari de Bellvitge

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

Condition or disease Intervention/treatment Phase
Morbid Obesity Sleeve Gastrectomy Early Discharge Safety Issues Other: Early discharge Other: Conventional protocol Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety of an Early Discharge Protocol After Sleeve Gastrectomy. Randomised Clinical Trial
Estimated Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 31, 2019

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



Primary Outcome Measures :
  1. Readmissions rate [ Time Frame: 1 month ]
    No hospital admissions after surgery


Secondary Outcome Measures :
  1. Morbidity rate [ Time Frame: 1 month ]
    Number of postoperative complications

  2. Chronogram for complications after surgery [ Time Frame: 1 month ]
    Detailed timing of appearance

  3. Quality of life [ Time Frame: 1 month ]
    BAROS questionnaire

  4. Patients agreement to the protocol [ Time Frame: 1 month ]
    Specific survey created ad hoc



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070457


Contacts
Contact: Amador Garcia Ruiz de Gordejuela, MD, PhD +35932607621 agrgordejuela@bellvitgehospital.cat

Locations
Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Sponsors and Collaborators
Hospital Universitari de Bellvitge

Responsible Party: Amador Garci-a Ruiz de Gordejuela, MD, PhD, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT03070457     History of Changes
Other Study ID Numbers: AC007/17
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amador Garci-a Ruiz de Gordejuela, Hospital Universitari de Bellvitge:
bariatric surgery
sleeve gastrectomy
eras

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms