the Related Factors of Bariatric Surgery on Liver Function

NCT03689790 | Unknown

• 1 other identifier: FirstJinanU20180213
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity and related metabolic diseases have become a chronic disease that is a threat to human health. Bariatric surgery can effectively and long-term reduce excess body weight and relieve related metabolic diseases, including type 2 diabetes. Laparoscopic gastric bypass surgery and laparoscopic sleeve gastrectomy are commonly used in bariatric surgery. Laparoscopic sleeve gastrectomy due to simple operation, good weight loss, and metabolic disease control effect, which is more widely used. However, there are several studies that show an increased chance of gastroesophageal reflux disease after laparoscopic sleeve gastrectomy. Long-term gastroesophageal reflux may lead to Barrett's esophagus or esophageal cancer. Nowadays, the cause of gastroesophageal reflux disease after sleeve gastrectomy is not clear and precautionary measures are not precise. In this study, prospective randomized controlled trials were conducted to explore the possible causes of liver funnction after bariatric surgery and to explore ways to prevent liver functione after bariatric surgery

Conditions

Liver Function; Bariatric Surgery

Outcome Measures

Primary Outcomes (4)

• preoperative of aminotransferase aspartate

  Aminotransferase aspartate in U/L

  Preoperative

• Postoperative of aminotransferase aspartate at 3 months

  Aminotransferase aspartate in U/L

  3 months

• Postoperative of aminotransferase aspartate at 6 months

  Aminotransferase aspartate in U/L

  6 months

• Postoperative of aminotransferase aspartate at 1 year

  Aminotransferase aspartate in U/L

  1 year

Secondary Outcomes (4)

• preoperative of alanine aminotransferase

  Preoperative

• Postoperative of alanine aminotransferase at 3 months

  3 months

• Postoperative of alanine aminotransferase at 6 months

  6 months

• Postoperative of alanine aminotransferase at 1 year

  1 year

Study Arms (1)

liver function

ACTIVE COMPARATOR

liver function

Procedure: sleeve gastrectomy; Procedure: gastric bypass

Interventions

sleeve gastrectomy PROCEDURE

sleeve gastrectomy

liver function

gastric bypass PROCEDURE

gastric bypass

liver function

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For the choice of surgical approach, numerous studies have shown that BMI ≧ 45, the general choice of gastric bypass surgery, BMI \<45, you can choose sleeve gastrectomy. The remission rate for T2DM, sleeve gastrectomy has a good result for young patients with shorter duration. In the investigator's country, the BMI less than 45 is majorities.

You may not qualify if:

• BMI\<27.5

Sponsors & Collaborators

• First Affiliated Hospital of Jinan University: lead

Study Sites (1)

The frist affiliated hospital of Jinan University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Interventions

Gastric Bypass

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of bariatric surgery

Study Record Dates

• First Submitted: June 3, 2018
• First Posted: September 28, 2018
• Study Start: April 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: September 28, 2018

Record last verified: 2018-09

Locations

CN (1)