Development of Machine Learning Models to Predict Postoperative GERD Symptom Resolution After Laparoscopic Nissen Fundoplication

NCT06862037 | Active Not Recruiting

• 1 other identifier: LNF-ML-D
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop machine learning models to predict postoperative gastroesophageal reflux symptom resolution after laparoscopic Nissen fundoplication using Elastic Net regression and synthetic minority oversampling technique (SMOTE).

Conditions

Gastroesophageal Reflux Disease (GERD); Gastroesophageal Reflux (GER)

Keywords

Gastroesophageal reflux disease; Laparoscopic Nissen fundoplication; Machine learning; Elastic Net regression; SMOTE; endoscopy; esophagogastroduodenoscopy; esophageal pH monitoring; manometry

Outcome Measures

Primary Outcomes (1)

• Model performance of novel models

  A total of 21 models will be developed to predict the resolution of heartburn, regurgitation, or atypical symptoms using the results of manometry, 24-hour esophageal pH monitoring, or both, with seven models for each symptom. All models will also incorporate the results of EGD. Elastic Net regression and the SMOTE method will be applied to oversample the minority class and develop the model. Model performance including AUC, sensitivity (or recall), specificity, accuracy, precision, and F1 score will be validated using 5-fold cross-validation.

  Symptoms were assessed before surgery and at 1, 3, 6, 9, and 12 months after surgery

Secondary Outcomes (1)

• Results from calibration analysis of novel models

  Symptoms were assessed before surgery and at 1, 3, 6, 9, and 12 months after surgery

Other Outcomes (1)

• Predictive performance of conventional predictors and possible predictors

  Symptoms were assessed before surgery and at 1, 3, 6, 9, and 12 months after surgery

Study Arms (2)

Symptom resolution group

Preoperative and postoperative gastroesophageal symptoms, including heartburn and regurgitation, were evaluated using the GERD-HRQL and the Korean version of the GERD questionnaire. Postoperative symptoms were assessed at 1, 3, 6, 9, and 12 months after laparoscopic Nissen fundoplication. Patients with more than a 70% improvement in symptoms at the last follow-up will be classified as the symptom resolution group.

Procedure: Laparoscopic Nissen fundoplication

Symptom non-resolution group

Preoperative and postoperative gastroesophageal symptoms, including heartburn and regurgitation, were evaluated using the GERD-HRQL and the Korean version of the GERD questionnaire. Postoperative symptoms were assessed at 1, 3, 6, 9, and 12 months after laparoscopic Nissen fundoplication. Patients with less than a 70% improvement in symptoms at the last follow-up will be classified as the symptom non-resolution group.

Procedure: Laparoscopic Nissen fundoplication

Interventions

Laparoscopic Nissen fundoplication PROCEDURE

Laparoscopic Nissen fundoplication (LNF) is the most commonly performed anti-reflux surgery. LNF is performed in patients with GERD refractory to medication or those expected to require long-term medical treatment. During LNF, the fundus of the stomach is mobilized and wrapped 360 degrees around the lower esophagus to reinforce the lower esophageal sphincter (LES), preventing the reflux of gastric contents into the esophagus.

Symptom non-resolution group; Symptom resolution group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent laparoscopic Nissen fundoplication

You may qualify if:

• patients with age greater than 19 years
• patients who underwent laparoscopic Nissen fundoplication from February 2017 to February 2023
• patients who answered the GERD-HRQL questionnaire or the Korean version of the GERD questionnaire to assess preoperative and postoperative gastroesophageal reflux symptoms
• patients who underwent esophagogastroduodenoscopy before surgery
• patients who underwent esophageal manometry, 24-hour esophageal pH monitoring, or both before surgery

You may not qualify if:

• pregnant
• patients who were lost to follow-up before 3 months after surgery

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Related Publications (6)

• Tay JK, Narasimhan B, Hastie T. Elastic Net Regularization Paths for All Generalized Linear Models. J Stat Softw. 2023;106:1. doi: 10.18637/jss.v106.i01. Epub 2023 Mar 23.

  PMID: 37138589 BACKGROUND

• Park S, Park SH, Kim MS, Kwak J, Lee I, Kwon Y, Lee CM, Choi HS, Keum B, Yang KS, Park JM, Park S. Exploring objective factors to predict successful outcomes after laparoscopic Nissen fundoplication. Int J Surg. 2023 May 1;109(5):1239-1248. doi: 10.1097/JS9.0000000000000274.

  PMID: 37026848 BACKGROUND

• Jung SW, Lee I, Lee I, Kim JW, Alromi A, Seo WJ, Park SH, Kwon Y, Jang YJ, Lee CM, Kim JH, Park JM, Park S. Bolus exposure as a novel predictor of postoperative symptom resolution after laparoscopic Nissen fundoplication: a two-institutional retrospective cohort study. Int J Surg. 2024 Dec 1;110(12):7919-7928. doi: 10.1097/JS9.0000000000002124.

  PMID: 39453844 BACKGROUND

• Farrell TM, Richardson WS, Trus TL, Smith CD, Hunter JG. Response of atypical symptoms of gastro-oesophageal reflux to antireflux surgery. Br J Surg. 2001 Dec;88(12):1649-52. doi: 10.1046/j.0007-1323.2001.01949.x.

  PMID: 11736981 BACKGROUND

• Yamasaki T, Fass R. Reflux Hypersensitivity: A New Functional Esophageal Disorder. J Neurogastroenterol Motil. 2017 Oct 30;23(4):495-503. doi: 10.5056/jnm17097.

  PMID: 28992673 BACKGROUND

• Zhang D, Liu S, Li Z, Wang R. Global, regional and national burden of gastroesophageal reflux disease, 1990-2019: update from the GBD 2019 study. Ann Med. 2022 Dec;54(1):1372-1384. doi: 10.1080/07853890.2022.2074535.

  PMID: 35579516 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 6, 2025
• Study Start: February 1, 2017
• Primary Completion: February 28, 2024
• Study Completion: August 31, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)