Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 2:42 AM
Ignite Modification Date: 2025-12-25 @ 2:42 AM
NCT ID: NCT06835933
Brief Summary: This study aims to investigate the patterns of reflux symptoms after laparoscopic sleeve gastrectomy based on the presence or absence of preoperative gastroesophageal reflux symptoms.
Detailed Description: Obesity is a well-known risk factor for gastroesophageal reflux disease (GERD), and laparoscopic sleeve gastrectomy (LSG) is the most commonly performed bariatric/metabolic surgery. However, patients often experience reflux symptoms after LSG, and those with severe reflux symptoms or severe erosive esophagitis have been excluded from candidates for LSG. This study aims to analyze the patterns of postoperative reflux symptoms based on the presence of preoperative reflux symptoms. Prospectively established databases of patients assessed for reflux symptoms at a single institution will be retrospectively reviewed. A total of 64 patients who underwent LSG between April 2020 and March 2023 will be included in this study. The modified GERD-HRQL (GERD- health-related quality of life) questionnaire was used to evaluate gastroesophageal reflux symptoms before LSG and at 1, 3, 6, 9, and 12 months after surgery. Reflux symptoms will be categorized into heartburn and regurgitation, and the patterns of heartburn and regurgitation scores included in the modified GERD-HRQL questionnaire will be analyzed. The patients will be classified based on the presence or absence of preoperative reflux symptoms, and the patterns of symptom scores within each group will be analyzed. We will also measure the correlation between whether hiatal hernia repair was performed with laparoscopic sleeve gastrectomy and adiposity-related parameters, including preoperative and postoperative body mass index (BMI), preoperative and postoperative waist circumference (WC), the percentage of total weight loss (%TWL), and the percentage of WC reduction, and changes in postoperative symptom scores.
Study: NCT06835933
Study Brief:
Protocol Section: NCT06835933