Feasibility of Laparoscopic Sleeve Gastrectomy in Day Case Surgery (GASTRAMBU)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01513005
First received: January 16, 2012
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

The aim of this study is to determinate the feasibility of the Laparoscopic Sleeve Gastrectomy, a bariatric surgery i.e. a surgery as a treatment for obesity, could be proposed as a Day-Case surgery.


Condition Intervention
Obesity
Procedure: Laparoscopic Sleeve Gastrectomy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Day Case Management by Laparoscopic Sleeve Gastrectomy for Obesity: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • unexpected admission rate [ Time Frame: the day following the surgery ] [ Designated as safety issue: Yes ]
    the unexpected admission rate corresponds to the number of overnight hospitalization i.e. the number of patients not treated considering a Day-Case Surgery.


Secondary Outcome Measures:
  • readmission rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    the readmission rate is defined as the number of readmission with conventional hospitalization

  • unexpected consultation rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    the unexpected consultation rate corresponds to the number of consultations after the Laparoscopic Sleeve Gastrectomy because of a postoperative outcome (adverse event, pain...)

  • reoperation rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • overall length of stay [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    the overall length of stay corresponds to the duration of all hospitalizations i.e. between the surgical procedure and the end of follow up.

  • per operative outcomes [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    the per operative outcomes include each event observed during the surgical procedure

  • postoperative outcomes [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    the postoperative outcomes include all outcomes reported during the follow-up period

  • efficiency of Laparoscopic Sleeve Gastrectomy [ Time Frame: six months ] [ Designated as safety issue: No ]
    the efficiency of Laparoscopic Sleeve Gastrectomy is evaluated with the BAROS questionnaire


Enrollment: 30
Study Start Date: May 2011
Study Completion Date: May 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laparoscopic Sleeve Gastrectomy Procedure: Laparoscopic Sleeve Gastrectomy

the operative technique consists in few steps:

  • position of 4 trocars and insertion of a nasogastric tube
  • dissection and mobilization of the greater curvature of the stomach
  • preparation of the stomach for division
  • gastric partition
  • extraction of the gastric remnant
  • postoperative surveillance

Detailed Description:

The purpose of this study is to investigate whether the patients with morbid obesity requiring a surgical approach by Laparoscopic Sleeve Gastrectomy could be operated according to a "day-case surgery" modality.

The sequence of this study is the following:

  1. patients consultation for bariatric management: during this consultation, the investigator is looking for exclusion criteria and prescribes laboratory tests.
  2. medical records of each patient are reviewed by an obesity-related staff: Laparoscopic Sleeve Gastrectomy is proposed.
  3. during a second consultation, the surgeon informed the patient about the proposition of the staff and his potential inclusion in this study
  4. after obtained his consent, the surgical procedure is planned and Laparoscopic Sleeve Gastrectomy is done in the Day-Case Surgery Unit.
  5. the following day the surgery, a nurse calls the patient to identify a potential postoperative outcome (nausea, vomiting, uncontrolled pain...)
  6. the 8th postoperative day, a consultation is done with laboratory tests and dietary follow-up.
  7. follow-up consultations are scheduled at 3, 6 and 12 months to evaluate the efficiency of the surgery procedure.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • sufficient understanding
  • good observance of medical prescription
  • availability of a responsible adult for the first operative night
  • patients living nearby the hospital (1 h maximum away)
  • telephonic accessibility
  • between 18 and 60 years old adults
  • body mass index less than 60 kg/m2
  • obesity requiring bariatric surgery
  • surgery validated by an obesity-related staff

Exclusion Criteria:

  • patient under administrative or legal protection
  • obesity without HAS criteria
  • cardiovascular comorbidity
  • pulmonary comorbidity
  • curative anticoagulant therapy
  • bad diabetes control
  • body mass index higher than 60 kg/m2
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513005

Locations
France
North Universitary Hospital
Amiens, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Jean-Marc REGIMBEAU, MD,phD CHU Amiens
  More Information

Publications:
Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01513005     History of Changes
Other Study ID Numbers: PI10-PR.-REGIMBEAU, 2010-A01178-31
Study First Received: January 16, 2012
Last Updated: February 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Laparoscopic Sleeve Gastrectomy
obesity management

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

ClinicalTrials.gov processed this record on September 18, 2014