Preoperative Predictors of Clinically Significant Symptom Improvement Twelve Months After Laparoscopic Fundoplication for Gastroesophageal Reflux Disease: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 470
- 试验地点
- 1
- 主要终点
- Responder status: proportion of participants achieving clinically significant symptom improvement
研究概览
简要总结
Laparoscopic fundoplication is the standard operation for gastroesophageal reflux disease (GERD) that does not respond adequately to medication, and it relieves reflux symptoms in most patients who are carefully selected for it. Even so, published studies consistently report that between 10% and 30% of patients continue to have symptoms afterwards, develop troublesome side effects such as difficulty swallowing or bloating, or are dissatisfied with the result. Much of this disappointment reflects who was chosen for surgery rather than any technical fault in the operation: patients whose symptoms are not actually caused by acid reflux predictably gain little benefit from a well-constructed wrap.
Individual factors measured before surgery, such as the amount of acid in the esophagus, the link between symptoms and reflux episodes, the type of symptoms, and how well the patient responded to acid-suppressing tablets, have each been linked to the outcome. However, most of that evidence comes from retrospective studies that used different definitions of success, so it is still unclear which factors matter independently once they are considered together.
This study will follow adults with objectively confirmed GERD who are scheduled for elective laparoscopic fundoplication at Minia University Hospitals. Before surgery, every participant undergoes the same standardized assessment: upper endoscopy, 24-hour pH-impedance monitoring off acid-suppressing medication, high-resolution manometry, measurement of height and weight, and questionnaires covering reflux symptoms, anxiety, depression and physical symptom burden. Participants then complete validated symptom questionnaires again at 1, 3, 6 and 12 months after the operation.
The main measure of success is "responder status" at 12 months, meaning at least a 50% improvement in the total GERD-HRQL symptom score compared with before surgery, supported by the patient's own rating of satisfaction. The investigators will analyze ten factors recorded before surgery to determine which of them independently predict this outcome, and will use the results to build and test a prediction tool that surgeons can apply during preoperative counseling.
The study does not assign any treatment. The type of wrap performed, either a complete (Nissen) or a partial posterior (Toupet) fundoplication, is chosen by the treating surgeon according to a prespecified rule based on esophageal motility, exactly as in routine practice. Taking part involves completing questionnaires and attending the usual follow-up appointments, and adds no additional procedural risk.
详细描述
BACKGROUND AND RATIONALE Gastroesophageal reflux disease affects an estimated 10-20% of adults in Western populations, with a rising prevalence elsewhere. Most patients are controlled with lifestyle measures and proton-pump inhibitor (PPI) therapy, but a substantial subgroup has medically refractory disease, troublesome regurgitation, PPI dependence with concerns about long-term use, or a large hiatal hernia. For these patients, laparoscopic fundoplication remains the most durable and widely performed antireflux operation, and it normalizes esophageal acid exposure in the majority of appropriately selected patients.
Published series nonetheless report that a meaningful minority, commonly 10-30%, experience persistent or recurrent symptoms, troublesome side effects such as dysphagia or gas-bloat, or dissatisfaction with the outcome. Suboptimal results are frequently attributable not to technical failure but to patient selection. Operating on patients whose symptoms are not driven by acid reflux, for example those with functional heartburn or esophageal hypersensitivity, predictably yields poor symptomatic benefit despite a technically sound wrap.
Several preoperative factors have been individually associated with symptomatic outcome. Objective pathological acid exposure, a positive symptom-reflux association, predominance of typical symptoms, and a good preoperative response to acid-suppressive therapy have each been linked to favorable results. Atypical or extra-esophageal symptom predominance, normal acid exposure, high psychological burden, obesity, and certain motility abnormalities have been associated with less benefit. Much of this evidence derives from heterogeneous retrospective series with differing outcome definitions, and the independent contribution of each factor, when modeled together and adjusted for confounding within a contemporary diagnostic framework (Lyon Consensus; Chicago Classification version 4.0), remains incompletely defined.
OBJECTIVES Primary objective: to identify the independent preoperative predictors of clinically significant symptom improvement 12 months after laparoscopic fundoplication.
Secondary objectives: to estimate the proportion of patients achieving clinically significant symptom improvement at 12 months; to identify preoperative predictors of secondary outcomes including discontinuation of antisecretory therapy, resolution of regurgitation, and postoperative dysphagia and gas-bloat symptoms; to develop and internally validate a multivariable prediction model and an optional simplified risk score; and to examine the concordance between subjective symptom improvement and objective reflux control in the subgroup undergoing postoperative physiological retesting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Objectively documented gastroesophageal reflux disease, defined by at least one of the following: pathological acid exposure on off-PPI 24-hour pH or pH-impedance monitoring; Los Angeles grade C or D esophagitis; biopsy-proven Barrett's esophagus; or a positive symptom-reflux association.
- •Medically refractory or PPI-dependent disease, troublesome regurgitation, or a symptomatic hiatal hernia, with an elective decision for laparoscopic fundoplication.
- •Able to provide written informed consent and to complete the study questionnaires.
排除标准
- •Previous antireflux or other major foregut or esophagogastric surgery.
- •Achalasia or a major esophageal motility disorder on high-resolution manometry (Chicago Classification version 4.0): absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypercontractile esophagus.
- •Giant or complex paraesophageal hernia requiring non-standard reconstruction, or a concurrent bariatric or other major intra-abdominal procedure.
- •Esophageal or gastric malignancy.
- •Emergency surgery.
- •Pregnancy.
- •Inability to complete patient-reported outcome instruments or to attend follow-up.
研究组 & 干预措施
Partial posterior (Toupet) fundoplication
Participants with ineffective esophageal motility on high-resolution manometry (Chicago Classification version 4.0) who undergo laparoscopic posterior partial 270-degree fundoplication. Allocation is by the treating team according to the prespecified motility-based algorithm reflecting routine care, not by the study.
干预措施: Laparoscopic Toupet fundoplication (Procedure)
Complete (Nissen) fundoplication
Participants with normal esophageal body motility on high-resolution manometry (Chicago Classification version 4.0) who undergo laparoscopic complete 360-degree fundoplication, fashioned as a short floppy 1.5-2 cm wrap calibrated over a 56-60 Fr bougie. Allocation is by the treating team according to the prespecified motility-based algorithm reflecting routine care, not by the study.
干预措施: Laparoscopic Nissen fundoplication (Procedure)
结局指标
主要结局
Responder status: proportion of participants achieving clinically significant symptom improvement
时间窗: 12 months after surgery
Proportion of participants classified as responders. A responder is a participant with a reduction of at least 50% in the total Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) score relative to baseline, corroborated by the patient's global satisfaction rating. The GERD-HRQL comprises 10 symptom items each scored from 0 (no symptoms) to 5 (symptoms incapacitating), giving a total score from 0 to 50, with higher scores indicating worse reflux-related quality of life, together with a separate global item on satisfaction with present condition. The outcome is analyzed as a binary variable, responder versus non-responder, and modeled against ten prespecified preoperative predictors by multivariable logistic regression with age and sex forced as covariates.
次要结局
- Patient satisfaction(6 and 12 months after surgery)
- Change from baseline in total GERD-HRQL score(Baseline and 1, 3, 6 and 12 months after surgery)
- Change from baseline in GerdQ score(Baseline and 1, 3, 6 and 12 months after surgery)
- Discontinuation of antisecretory therapy(12 months after surgery)
- Resolution of regurgitation(2 months after surgery)
- New or persistent dysphagia(12 months after surgery)
- Gas-bloat symptoms(12 months after surgery)
- Postoperative morbidity graded by the Clavien-Dindo classification(30 days after surgery)
- Reoperation and symptomatic recurrence(12 months after surgery)
研究者
Saleh Khairy Saleh MD
Lecturer of General Surgery, Department of Surgery, Faculty of Medicine
Minia University