Laparoscopic Sleeve Gastrectomy Under General Anesthesia in Severely Obese Patients: a Retrospective Study

August 19, 2020 updated by: Shengjin Ge,MD, Fudan University

Laparoscopic Sleeve Gastrectomy Under General Anesthesia in Severely Obese Patients: a Single-centered Retrospective Study in China

With the improvement of living standards and changes in living habits in China, obesity has become an important issue. The latest data show that the number of obese people in China has exceeded 100 million. Laparoscopic sleeve gastrectomy (LSG), which reduces the volume of the stomach and maintains the original anatomical structure of the gastrointestinal tract, has been widely used in weight loss surgery for obese patients to improve glucose metabolism and other metabolic disease comorbidities.Anesthesiologists face specific challenges for obese patients: difficult venous and airway access and the risk of obesity-related comorbidity.

Since 2015, the investigator's center has performed LSG and gradually formed a multidisciplinary collaboration procedure for the perioperative management of obese patients. This study aims to summarize the clinical characteristics, anesthesia management and outcomes to optimize the perioperative management and accelerate the recovery of these patients.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

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

    • Shanghai
      • Shanghai, Shanghai, China, 200032

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Severely obese patients underwent laparoscopic sleeve gastrectomy (LSG) under general anesthesia with multidisciplinary collaboration.

Description

Inclusion Criteria:

  1. patients aged>18 years
  2. American Society of Anesthesiologists (ASA) status I-III
  3. receiving selective laparoscopic sleeve gastrectomy (LSG) under general anesthesia

Exclusion Criteria:

1.BMI<35 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of one-time intubation success
Time Frame: during the anesthesia
the intubation was performed once successfully
during the anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of participants with anesthesia-related complications
Time Frame: Perioperative period
such as difficult ventilation, difficult intubation, or hoarseness.
Perioperative period
the hospital stay (days)
Time Frame: Perioperative period
total time of hospital stay (days)
Perioperative period
the hospitalization cost(Yuan)
Time Frame: Perioperative period
the total cost of the hospitalization (Yuan)
Perioperative period

Collaborators and Investigators

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

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 (Actual)

August 1, 2020

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

August 13, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Actual)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B2020-190

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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