Laparoscopic Total vs Partial Fundoplication in Patients With Atypical Symptoms of Gastroesophageal Reflux Disease

December 10, 2022 updated by: Mykola Paranyak

A Prospective Randomized Trial on Laparoscopic Total vs Partial Fundoplication in Patients With Atypical Symptoms of Gastroesophageal Reflux Disease

One hundred and twenty patients with documented extraesophageal symptoms of gastroesophageal reflux disease were randomized to either undergo floppy Nissen (n= 60) or Toupet fundoplication (n= 60). Symptom scores of extraesophageal symotoms and quality of life were prospectively evaluated. Analysis of the treatment results showed a significant improvement of symptoms in both patient groups.Quality of life improved substantially at short- and long-term follow up in both groups and there were no statistical differences between the groups in this parameter.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
      • Lviv, Ukraine, 79010
        • Danylo Halytsky Lviv National Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • extraesophageal symptoms of gastroesophageal reflux disease
  • undergoing surgery for gastroesophageal reflux disease
  • at least 18 years old

Exclusion Criteria:

  • patients under the age of 18 years
  • previous anti-reflux surgery, other surgical procedures in the vicinity of the gastroesophageal junction
  • major psychiatric illness
  • unstable chronic illnesses (such as diabetes)
  • inability of the patient to complete the survey.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: laparoscopic Nissen fundoplication
Creation of a 360° fundoplication wrap over a 30-Fr intra-esophageal bougie.
Procedure: Laparoscopic fundoplication
Creation of either a 360° (in Nissen group) or a 270° (in Toupet group) fundoplication wrap over a 30-Fr intra-esophageal bougie.
Active Comparator: laparoscopic Toupet fundoplication
Creation of a 270° fundoplication wrap over a 30-Fr intra-esophageal bougie.
Procedure: Laparoscopic fundoplication
Creation of either a 360° (in Nissen group) or a 270° (in Toupet group) fundoplication wrap over a 30-Fr intra-esophageal bougie.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptom scores of throat clearing, globus sensation, cough, throat pain, vocal changes.
Time Frame: 24 month
24 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reflux symptom index (RSI) score
Time Frame: 24 months
The reflux symptom index (RSI) questionnaire is a nine-item, 45-point survey used in the evaluation of symptoms of laryngopharyngeal reflux. A RSI score higher than 13 is considered abnormal and indicates the presence of laryngopharyngeal reflux.
24 months
laryngopharyngeal reflux-health-related quality of life (LPR-HRQL) questionnaire score
Time Frame: 24 months
The LPR-HRQL questionnaire is a 43-item survey, designed to assess the effects of extraesophageal reflux symptoms on social and occupational functioning, vitality, well-being and perceived health.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mykola Paranyak

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

April 6, 2021

Study Completion (Actual)

April 6, 2021

Study Registration Dates

First Submitted

December 3, 2022

First Submitted That Met QC Criteria

December 3, 2022

First Posted (Actual)

December 12, 2022

Study Record Updates

Last Update Posted (Estimate)

December 13, 2022

Last Update Submitted That Met QC Criteria

December 10, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2708A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Will be decided after publication of the article

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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