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

NCT ID: NCT06862037

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2025-08-31

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).

Detailed Description

In patients with gastroesophageal reflux disease (GERD) refractory to medication or those expected to require long-term medical treatment, anti-reflux surgery (ARS), including Nissen fundoplication, has been performed. GERD is usually diagnosed as esophageal mucosal damage or pathological esophageal acid exposure. However, about 35% of patients with gastroesophageal reflux symptoms do not exhibit abnormal findings on esophagogastroduodenoscopy (EGD) and esophageal pH monitoring. Meanwhile, about 10% of patients with typical GERD symptoms and 30-50% of those with atypical GERD symptoms do not experience symptom improvement even after undergoing ARS. Therefore, the importance of predicting symptom improvement after ARS and appropriately selecting surgical candidates has been increasingly emphasized.

Though previous studies have suggested several predictors-including the length of the lower esophageal sphincter (LES), resting pressure of the LES, and bolus exposure time-to predict GERD symptom resolution after ARS, no model comprehensively integrated the results of EGD, esophageal pH monitoring, and manometry.

Elastic Net regression is a machine learning method that utilizes regularized regression analysis, combining L1 (Lasso) and L2 (Ridge) penalties. This approach makes the model relatively robust against overfitting and is suitable for datasets with a small sample size, a large number of variables, and severe multicollinearity. Synthetic minority oversampling technique (SMOTE) is a method that enhances the interpretability of the minority class in a model by oversampling minority class data using the k-nearest neighbors (k-NN) algorithm. Therefore, this study aims to develop machine learning models to predict postoperative gastroesophageal reflux symptom resolution after laparoscopic Nissen fundoplication using Elastic Net regression and SMOTE.

A total of 112 patients who underwent LNF between February 2017 to February 2023 will be included in this study. Preoperative and postoperative gastroesophageal symptoms, including heartburn and regurgitation, were evaluated using the GERD Health-Related Quality of Life (GERD-HRQL) questionnaire and the Korean version of the GERD questionnaire. Postoperative symptoms were assessed at 1, 3, 6, 9, and 12 months after surgery. Patients with more than a 70% improvement in symptoms at the last follow-up will be classified as the symptom resolution group. 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 will be validated using 5-fold cross-validation. In addition to assessing model discrimination, calibration analysis will be performed to evaluate how well the predicted probabilities align with observed outcomes. The predictive performance of conventional predictors and possible predictors, including the length of LES, resting pressure of the LES, and bolus exposure time, will be compared with the model performance of the novel model.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Laparoscopic Nissen fundoplication

Intervention Type: 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

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.

Laparoscopic Nissen fundoplication

Intervention Type: 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.

Interventions

Laparoscopic Nissen fundoplication

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. patients with age greater than 19 years

2. patients who underwent laparoscopic Nissen fundoplication from February 2017 to February 2023

3. patients who answered the GERD-HRQL questionnaire or the Korean version of the GERD questionnaire to assess preoperative and postoperative gastroesophageal reflux symptoms

4. patients who underwent esophagogastroduodenoscopy before surgery

5. patients who underwent esophageal manometry, 24-hour esophageal pH monitoring, or both before surgery

Exclusion Criteria

1. pregnant

2. patients who were lost to follow-up before 3 months after surgery

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea University Anam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sungsoo Park

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Korea University Anam Hospital

Seoul, , South Korea

Countries

South Korea

References

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Reference Type: BACKGROUND

PMID: 37138589 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37026848 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39453844 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11736981 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28992673 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35579516 (View on PubMed)

Other Identifiers

LNF-ML-D

Identifier Type: -

Identifier Source: org_study_id