the Related Factors of Bariatric Surgery on Gastroesophageal Reflux Disease

NCT03497494 | Unknown

• 1 other identifier: FirstJinanU20180120
• Study Type: interventional
• Target: 180
• 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 gastroesophageal reflux after sleeve gastrectomy and to explore ways to prevent gastroesophageal reflux disease after sleeve gastrectomy.

Conditions

Gastroesophageal Reflux; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• GERD-Health Related Quality of Life Questionnaire

  Total Score: Calculated by summing the individual scores to questions 1-15. * Greatest possible score (worst symptoms) = 75 * Lowest possible score (no symptoms) = 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6 . * Worst heartburn symptoms = 30 * No heartburn symptoms = 0 * Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. 2 Regurgitation Score: Calculated by summing the individual scores to questions 10-15. * Worst regurgitation symptoms = 30 * No regurgitation symptoms = 0 * Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.

  1 year

Secondary Outcomes (8)

• preoperative and postoperative of abdominal ultrasound to examine the abdominal fat thickness

  1 year

• Preoperative and postoperative BMI

  1 year

• Preoperative and postoperative waist circumference

  1 year

• Preoperative and postoperative abdominal circumference

  1 year

• Preoperative and postoperative chest circumference

  1 year

Study Arms (2)

Without hiatal suture

ACTIVE COMPARATOR

the different distance of pylorus without hiatal suture

Procedure: 2 cm away from the pylorus edge; Procedure: 4 cm away from the pylorus edge; Procedure: 6 cm away from the pylorus edge; Procedure: LRYGB

With hiatal suture

ACTIVE COMPARATOR

the different distance of pylorus without hiatal suture

Procedure: 2 cm away from the pylorus edge; Procedure: 4 cm away from the pylorus edge; Procedure: 6 cm away from the pylorus edge

Interventions

2 cm away from the pylorus edge PROCEDURE

2 cm away from the pylorus edge

With hiatal suture; Without hiatal suture

4 cm away from the pylorus edge PROCEDURE

4 cm away from the pylorus edge

With hiatal suture; Without hiatal suture

6 cm away from the pylorus edge PROCEDURE

6 cm away from the pylorus edge

With hiatal suture; Without hiatal suture

LRYGB PROCEDURE

laparoscopic Roux-en-Y gastric bypass

Also known as: laparoscopic Roux-en-Y gastric bypass

Without hiatal suture

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 our 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

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of bariatric surgery

Model Details: All patients enrolled in this study underwent laparoscopic sleeve gastrectomy. According to the starting point of resection to pylorus distance and whether to the strengthen suture of esophageal hole, the cases were randomly divided into 6 groups: G1: 2 cm away from the pylorus edge, without hiatal suture; G2: 4 cm away from the pylorus edge, without hiatal suture; G3: 6 cm away from the pylorus edge, without hiatal suture; G4: 2 cm away from the pylorus edge, with hiatal suture G5: 4 cm away from the pylorus edge, with hiatal suture; G6: 6 cm away from the pylorus edge, with hiatal suture;

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: April 13, 2018
• Study Start: January 20, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2020
• Last Updated: April 13, 2018

Record last verified: 2018-04

Locations

CN (1)