Intraoperative Endomanometric Laparoscopic Nissen Fundoplication Improves Postoperative Outcomes

Not Applicable

Completed

• Conditions: GERD
• Interventions: Procedure: endomanometric guided LNF; Procedure: laparoscopic Nissen fundoplication alone

• Registration Number: NCT05851794
• Lead Sponsor: Zagazig University

Brief Summary

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

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 Timeline

• Study Start: 2012-04-01
• Primary Completion: 2020-04-01
• Study Completion: 2023-04-01
• Study First Submitted: 2023-05-01
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endomanometric laparoscopic Nissen fundoplication	endomanometric guided LNF	use endomanometry and endoscope during laparoscopic Nissen fundoplication
laparoscopic Nissen fundoplication alone	laparoscopic Nissen fundoplication alone	laparoscopic Nissen fundoplication only

Primary Outcome Measures

Name	Time	Method
DeMeester score (0-3)	3 years	0 is best while 3 is worst
dysphagia score(0-3)	3 years	0 is best while 3 is worst