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Completed

NCT Number: NCT01513005

Feasibility of Laparoscopic Sleeve Gastrectomy in Day Case Surgery

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Universitary Hospital

Amiens, 80054, France

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic sleeve gastrectomy

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. readmission rate

    Time frame: one year

    the readmission rate is defined as the number of readmission with conventional hospitalization

  2. 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...)

  3. reoperation rate

    Time frame: one year

  4. 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.

  5. per operative outcomes

    Time frame: one year

    the per operative outcomes include each event observed during the surgical procedure

  6. postoperative outcomes

    Time frame: one year

    the postoperative outcomes include all outcomes reported during the follow-up period

  7. efficiency of Laparoscopic Sleeve Gastrectomy

    Time frame: six months

    the efficiency of Laparoscopic Sleeve Gastrectomy is evaluated with the BAROS questionnaire

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: GASTRAMBU

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jan 20, 2012
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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