Intraoperative Endomanometric Laparoscopic Nissen Fundoplication Improves Postoperative Outcomes

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT05851794
Collaborator
(none)
360
2
132

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: endomanometric guided LNF
  • Procedure: laparoscopic Nissen fundoplication alone
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
360 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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.
Actual Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Apr 1, 2020
Actual Study Completion Date :
Apr 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. DeMeester score (0-3) [3 years]

    0 is best while 3 is worst

  2. dysphagia score(0-3) [3 years]

    0 is best while 3 is worst

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 69 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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,

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Zagazig University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tamer.A.A.M.Habeeb, professour of general and laparoscopic surgery, Zagazig University
ClinicalTrials.gov Identifier:
NCT05851794
Other Study ID Numbers:
  • GERD
First Posted:
May 10, 2023
Last Update Posted:
May 11, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 11, 2023