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NCT05647668 Clinical Trial

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

Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05647668
Other study ID # 2708A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date April 6, 2021

Study information
Verified date December 2022
Source Danylo Halytsky Lviv National Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date April 6, 2021
Est. primary completion date April 6, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Ukraine Danylo Halytsky Lviv National Medical University Lviv

Sponsors (1)
Lead Sponsor Collaborator
Mykola Paranyak

Country where clinical trial is conducted

Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptom scores of throat clearing, globus sensation, cough, throat pain, vocal changes. 24 month
Secondary 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. 24 months
Secondary 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. 24 months
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