Long Term Incidence and Effect of de Novo GERD After Laparoscopic Sleeve Gastrectomy in Chinese Population

August 29, 2023 updated by: Cheung Yau Fung, Chinese University of Hong Kong

Long Term Incidence and Effect of Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy in Chinese Population

To evaluate the long-term incidence and effects of gastroesophageal reflux disease in the Chinese population after laparoscopic sleeve gastrectomy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Laparoscopic sleeve gastrectomy (SG) has gained popularity as a primary bariatric procedure in the past decade. According to the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), 43.6% of all bariatric procedures performed worldwide were SG between 2013 and 2017. Long term data of SG have shown that the procedure is able to achieve adequate weight loss and metabolic outcomes compared with other bariatric procedures. Furthermore, it has gained popularity due to its relatively simpler procedure, shorter operative time, avoidance of intestinal anatomy rearrangement, anastomosis, risk of internal hernia, and lower risk of malnutrition.

One major drawback to SG is potential development of gastrointestinal reflux disease (GERD). According to the Montreal Classification, GERD is defined as heartburn and regurgitation because of reflux contents of the stomach into the esophagus, causing symptoms that interferes with physical activity, disturbs sleep and reduce productivity at work . It has been shown to significant impact on patients' post-operative quality of life negatively . Currently there are discrepancy in the medical literature, while some studies found worsening of GERD or development of GERD (de novo GERD) after SG, some found improvement of GERD post-operatively. From a recent meta-analysis by Yeung et al comprising 10, 718 patients with follow-up period from 3 to 132 months, 19% of patients experienced worsening of GERD while 23% developed de novo GERD after SG.

Furthermore, long term complications of GERD include the development of erosive esophagitis, Barret's esophagus and even esophageal adenocarcinoma. From the same meta-analysis, the long-term prevalence (>24 months) of erosive esophagitis and Barret's esophagus were 28% and 8% respectively. There have also been isolated case reports of development of esophageal adenocarcinoma after SG. From the investigators' literature review, four cases were reported. Two of the cases had no pre-operative endoscopy, one case had pre-operative diagnosis of Barret's esophagus. The other case developed esophageal adenocarcinoma despite normal pre-operative endoscopy 5 years after SG.

The epidemiology of GERD is different in Western countries and in Asian countries. Although the incidence of GERD has increased in the past decades, the prevalence of GERD was 5.2-8.5% base on symptoms. Prevalence of Barret's esophagus remained rare at 0.06-0.85%. In patents who have received SG, Tai et al showed that the prevalence of GERD increased from 12.1 to 47% based on Reflux Disease Questionnaire at one year after SG. The prevalence of erosive esophagitis also increased from 16.7 to 66.7%. based on upper gastrointestinal endoscopy findings at one year. In the long run, the prevalence of de novo GERD was 17-45% based on symptoms and proton pump inhibitors use from the case series by Pok et al. and Chang et al. with a follow-up period up to 7 years and 10 years respectively.

From the current Asian literature, data on long term incidence of GERD after SG based on objective assessment tools and endoscopy findings was lacking. There is also no adequate data on the long-term occurrence of erosive esophagitis and Barret's esophagus after SG, which would have important significance in pre-operative counselling.

The objective of the study is to evaluate the long-term incidence and effects of gastroesophageal reflux disease in the Chinese population after laparoscopic sleeve gastrectomy.

Study Type

Observational

Enrollment (Estimated)

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 Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Prince of Wales Hospital
        • Contact:
        • Principal Investigator:
          • Yau Fung Cheung, FRCSEd(Gen)
        • Sub-Investigator:
          • Kin Hung Wong, FRCSEd(Gen)

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Chinese patients who received laparoscopic sleeve gastrectomy at Prince of Wales Hospital, The Chinese University of Hong Kong for more than 36 months

Description

Inclusion Criteria:

  • Chinese patients who received laparoscopic sleeve gastrectomy at Prince of Wales Hospital, The Chinese University of Hong Kong
  • SG has been performed more than 36 months
  • Patient received preoperative OGD and GI symptom assessment with C-GIQLI questionnaire
  • Willing and able to consent to the study

Exclusion Criteria:

  • Revisional surgery
  • Concomitant surgeries (except hiatal repair/ cholecystectomy)
  • Mentally incompetent patients or patients less than 18 years old
  • Pregnant patients
  • Inmates
  • Unable/unwilling to consent to the study
  • Unable/unwilling to undergo follow-up assessments

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LSG
Chinese patients who received laparoscopic sleeve gastrectomy at Prince of Wales Hospital, The Chinese University of Hong Kong for more than 36 months
Procedure: Laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of de novo GERD
Time Frame: >36 months after surgery
Incidence of long term de novo gastroesophageal reflux disease after laparoscopic sleeve gastrectomy, as defined by: Patients who did not have pre-operative GERD; AND patients who scored ≥12 in the Chinese GERDQ questionnaire at ≥36 months after SG; and/or patients who scored ≤5 out of 8 marks in questions 26 (acid reflux) and 34 (heart burn), at ≥36 months after SG; and/or patients who had erosive esophagitis or Barret's esophagus at upper gastrointestinal endoscopy at ≥36 months after SG; and/or patients who required regular anti-reflux medications at ≥36 months after SG
>36 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in severity of GERD
Time Frame: >36 months after surgery
Changes in severity of GERD after SG in patients who had pre-operative GERD, defined by increase in anti-reflux medications usage and/or increase in severity of erosive esophagitis or Barret's esophagus at ≥36 months after SG
>36 months after surgery
Proportion of asymptomatic patients with endoscopic evidence of de novo GERD
Time Frame: >36 months after surgery
Proportion of patients who have endoscopic evidence of de novo GERD (erosive esophagitis or Barret's esophagus) but had no symptoms of de novo GERD
>36 months after surgery
Difference in quality of life in patient with or without de novo GERD
Time Frame: >36 months after surgery
Difference in quality of life as measured by C-GIQLI questionnaire between patients who have de novo GERD and patients who do not at ≥36 months after operation
>36 months after surgery

Collaborators and Investigators

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

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Yau Fung Cheung, FRCSEd(Gen), Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2020

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

January 17, 2020

First Submitted That Met QC Criteria

January 21, 2020

First Posted (Actual)

January 23, 2020

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2019.362

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Gastroesophageal Reflux

Clinical Trials on Laparoscopic sleeve gastrectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe