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

February 4, 2014 updated by: Centre Hospitalier Universitaire, Amiens

Feasibility of Day Case Management by Laparoscopic Sleeve Gastrectomy for Obesity: a Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • North Universitary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
unexpected admission rate
Time Frame: the day following the surgery
the unexpected admission rate corresponds to the number of overnight hospitalization i.e. the number of patients not treated considering a Day-Case Surgery.
the day following the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
readmission rate
Time Frame: one year
the readmission rate is defined as the number of readmission with conventional hospitalization
one year
unexpected consultation rate
Time Frame: one year
the unexpected consultation rate corresponds to the number of consultations after the Laparoscopic Sleeve Gastrectomy because of a postoperative outcome (adverse event, pain...)
one year
reoperation rate
Time Frame: one year
one year
overall length of stay
Time Frame: one year
the overall length of stay corresponds to the duration of all hospitalizations i.e. between the surgical procedure and the end of follow up.
one year
per operative outcomes
Time Frame: one year
the per operative outcomes include each event observed during the surgical procedure
one year
postoperative outcomes
Time Frame: one year
the postoperative outcomes include all outcomes reported during the follow-up period
one year
efficiency of Laparoscopic Sleeve Gastrectomy
Time Frame: six months
the efficiency of Laparoscopic Sleeve Gastrectomy is evaluated with the BAROS questionnaire
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

January 16, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Estimate)

February 5, 2014

Last Update Submitted That Met QC Criteria

February 4, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI10-PR.-REGIMBEAU
  • 2010-A01178-31 (Other Identifier: ID-RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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