search
Back to results

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

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Laparoscopic fundoplication
Sponsored by
Mykola Paranyak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Danylo Halytsky Lviv National Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

laparoscopic Nissen fundoplication

laparoscopic Toupet fundoplication

Arm Description

Creation of a 360° fundoplication wrap over a 30-Fr intra-esophageal bougie.

Creation of a 270° fundoplication wrap over a 30-Fr intra-esophageal bougie.

Outcomes

Primary Outcome Measures

Symptom scores of throat clearing, globus sensation, cough, throat pain, vocal changes.

Secondary Outcome Measures

Reflux symptom index (RSI) score
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.
laryngopharyngeal reflux-health-related quality of life (LPR-HRQL) questionnaire score
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.

Full Information

First Posted
December 3, 2022
Last Updated
December 10, 2022
Sponsor
Mykola Paranyak
search

1. Study Identification

Unique Protocol Identification Number
NCT05647668
Brief Title
Laparoscopic Total vs Partial Fundoplication in Patients With Atypical Symptoms of Gastroesophageal Reflux Disease
Official Title
A Prospective Randomized Trial on Laparoscopic Total vs Partial Fundoplication in Patients With Atypical Symptoms of Gastroesophageal Reflux Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
April 6, 2021 (Actual)
Study Completion Date
April 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mykola Paranyak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic Nissen fundoplication
Arm Type
Active Comparator
Arm Description
Creation of a 360° fundoplication wrap over a 30-Fr intra-esophageal bougie.
Arm Title
laparoscopic Toupet fundoplication
Arm Type
Active Comparator
Arm Description
Creation of a 270° fundoplication wrap over a 30-Fr intra-esophageal bougie.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic fundoplication
Intervention Description
Creation of either a 360° (in Nissen group) or a 270° (in Toupet group) fundoplication wrap over a 30-Fr intra-esophageal bougie.
Primary Outcome Measure Information:
Title
Symptom scores of throat clearing, globus sensation, cough, throat pain, vocal changes.
Time Frame
24 month
Secondary Outcome Measure Information:
Title
Reflux symptom index (RSI) score
Description
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.
Time Frame
24 months
Title
laryngopharyngeal reflux-health-related quality of life (LPR-HRQL) questionnaire score
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Danylo Halytsky Lviv National Medical University
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Will be decided after publication of the article

Learn more about this trial

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

We'll reach out to this number within 24 hrs