NCT04521543

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

August 13, 2020

Last Update Submit

August 19, 2020

Conditions

Keywords

severely obese

Outcome Measures

Primary Outcomes (1)

  • The rate of one-time intubation success

    the intubation was performed once successfully

    during the anesthesia

Secondary Outcomes (3)

  • number of participants with anesthesia-related complications

    Perioperative period

  • the hospital stay (days)

    Perioperative period

  • the hospitalization cost(Yuan)

    Perioperative period

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • BMI\<35 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 20, 2020

Study Start

August 1, 2020

Primary Completion

September 30, 2020

Study Completion

October 1, 2020

Last Updated

August 20, 2020

Record last verified: 2020-08

Locations