Intraoperative Endomanometric Laparoscopic Nissen Fundoplication Improves Postoperative Outcomes

Study Overview
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Brief Summary
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Laparoscopic Nissen fundoplication (LNF) is a surgical intervention for gastroesophageal reflux disease (GERD); however, it can be followed by recurrent symptoms or complications that may affect patient satisfaction. Intraoperative endomanometric evaluation of esophagogastric competence and pressure, combined with LNF in patients with large sliding hiatus hernia (>5cm) with severe GERD (DeMeester score >100), is needed.This is a retrospective, multicenter, comparative study. Baseline characteristics, initial reflux symptoms, preoperative and postoperative antacid medication use, postoperative complications (dysphagia and gas bloat syndrome), recurrent symptoms, and satisfaction were collected from a prospective database. Outcomes measures were recurrent reflux symptoms, postoperative side-effects, and satisfaction with surgery. Quantitative data were compared between the studied groups using the independent t-test or Mann-Whitney U test for normally and non-normally distributed numerical variables, respectively

Detailed Description
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Laparoscopic Nissen fundoplication (LNF) is a surgical intervention for gastroesophageal reflux disease (GERD); however, it can be followed by recurrent symptoms or complications that may affect patient satisfaction. Intraoperative endomanometric evaluation of esophagogastric competence and pressure, combined with LNF in patients with large sliding hiatus hernia (>5cm) with severe GERD (DeMeester score >100), is needed. Study design: This is a retrospective, multicenter, comparative study. Baseline characteristics, initial reflux symptoms, preoperative and postoperative antacid medication use, postoperative complications (dysphagia and gas bloat syndrome), recurrent symptoms, and satisfaction were collected from a prospective database. Outcomes measures were recurrent reflux symptoms, postoperative side-effects, and satisfaction with surgery. Quantitative data were compared between the studied groups using the independent t-test or Mann-Whitney U test for normally and non-normally distributed numerical variables, respectively. This study contributes to the mounting evidence for the effectiveness of endomanometric use during LNF. Intraoperative HRM and Endoscope were feasible in all patients and demonstrated that the clinical outcomes for endomanometric NF were favorable from an effectiveness and safety standpoint.

Official Title
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Intraoperative Endomanometric Laparoscopic Nissen Fundoplication Improves Postoperative Outcomes in Large Sliding Hiatus Hernia With Severe Gastroesophageal Reflux Disease (DeMeester Score >100). A Retrospective Comparative Study.

Conditions
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GERD

Intervention / Treatment
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* Procedure: endomanometric guided LNF
* Procedure: laparoscopic Nissen fundoplication alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients 18≥ years with large sliding hiatus hernia (> 5 cm) with severe GERD patients (DeMeester score >100)with typical symptoms and successful medical management (due to quality of life considerations, life-long need medication intake or cost) or patients with unresponsive or inadequate symptom control despite eight weeks of adequate medical therapy with or without extra-esophageal Atypical symptoms that are related to GERD(cough, Globus, or hoarseness) confirmed diagnosis by hypotensive lower esophageal sphincter confirmed by HRM and a positive pH/impedance test (based on DeMeester scores) fitness and consenting for surgery patients that completed three year follow up period, with esophagitis Exclusion Criteria: <18years, pregnancy, Patients unfit for surgery [ comorbid condition like severe cardiac illness, chronic respiratory diseases, chronic renal failure, and bleeding disorder], Non cooperative or lost patients for regular follow up, Patients who had undergone previous antireflux surgery or who required a concurrent abdominal procedure at the same time as fundoplication (eg, cholecystectomy), - psychiatric disorders. esophageal dysmotility,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: endomanometric laparoscopic Nissen fundoplication<br>use endomanometry and endoscope during laparoscopic Nissen fundoplication | Procedure: endomanometric guided LNF<br>* use of endomanometry during LNF<br>|
| Active Comparator: laparoscopic Nissen fundoplication alone<br>laparoscopic Nissen fundoplication only | Procedure: laparoscopic Nissen fundoplication alone<br>* laparoscopic Nissen fundoplication alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DeMeester score (0-3) | 0 is best while 3 is worst | 3 years | 
| dysphagia score(0-3) | 0 is best while 3 is worst | 3 years |