Skip to main content
OpenTrials
Completed

NCT Number: NCT05851794

Intraoperative Endomanometric Laparoscopic Nissen Fundoplication Improves Postoperative Outcomes

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this 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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

endomanometric guided LNF

Procedure

use of endomanometry during LNF

laparoscopic Nissen fundoplication alone

Procedure

laparoscopic Nissen fundoplication alone

Primary outcomes

  1. DeMeester score (0-3)

    Time frame: 3 years

    0 is best while 3 is worst

  2. dysphagia score(0-3)

    Time frame: 3 years

    0 is best while 3 is worst

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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.

Important dates

Study start
2012
Primary completion
2020
Study completion
2023
First posted
May 10, 2023
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.