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

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Procedure: Laparoscopic fundoplication

• Registration Number: NCT05647668
• Lead Sponsor: Mykola Paranyak

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2021-04-06
• Study Completion: 2021-04-06
• Status Verified: 2022-12
• Study First Submitted: 2022-12-03
• Study First Submitted QC: 2022-12-03
• Last Update Submitted: 2022-12-10
• Study First Posted: 2022-12-12
• Last Update Posted: 2022-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic Toupet fundoplication	Laparoscopic fundoplication	Creation of a 270° fundoplication wrap over a 30-Fr intra-esophageal bougie.
laparoscopic Nissen fundoplication	Laparoscopic fundoplication	Creation of a 360° fundoplication wrap over a 30-Fr intra-esophageal bougie.

Primary Outcome Measures

Name	Time	Method
Symptom scores of throat clearing, globus sensation, cough, throat pain, vocal changes.	24 month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Danylo Halytsky Lviv National Medical University; 🇺🇦 Lviv, Ukraine