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Completed

NCT Number: NCT05647668

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danylo Halytsky Lviv National Medical University

Lviv, 79010, Ukraine

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic fundoplication

Procedure

Creation of either a 360° (in Nissen group) or a 270° (in Toupet group) fundoplication wrap over a 30-Fr intra-esophageal bougie.

Primary outcomes

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

    Time frame: 24 month

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Mykola Paranyak

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 12, 2022
Registry last updated
Dec 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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