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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04521543
Other study ID # B2020-190
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date October 1, 2020

Study information

Verified date August 2020
Source Fudan University
Contact Shengjin Ge, Ph.D.
Phone 021-64041990
Email ge.shengjin@zs-hospital.sh.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 1, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Zhongshan Hospital Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of one-time intubation success the intubation was performed once successfully during the anesthesia
Secondary number of participants with anesthesia-related complications such as difficult ventilation, difficult intubation, or hoarseness. Perioperative period
Secondary the hospital stay (days) total time of hospital stay (days) Perioperative period
Secondary the hospitalization cost(Yuan) the total cost of the hospitalization (Yuan) Perioperative period
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