Intraoperative Endomanometric Laparoscopic Nissen Fundoplication Improves Postoperative Outcomes

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.

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

Study Overview

• Status: Completed
• Conditions: GERD
• Intervention / Treatment: Procedure: endomanometric guided LNF; Procedure: laparoscopic Nissen fundoplication alone

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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,

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: endomanometric laparoscopic Nissen fundoplication; use endomanometry and endoscope during laparoscopic Nissen fundoplication	Procedure: endomanometric guided LNF; use of endomanometry during LNF
Active Comparator: laparoscopic Nissen fundoplication alone; laparoscopic Nissen fundoplication only	Procedure: laparoscopic Nissen fundoplication alone; laparoscopic Nissen fundoplication alone

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2012
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: GERD (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No