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

NCT05647668 | Completed

• 1 other identifier: 2708A
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

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

  24 month

Secondary Outcomes (2)

• Reflux symptom index (RSI) score

  24 months

• laryngopharyngeal reflux-health-related quality of life (LPR-HRQL) questionnaire score

  24 months

Study Arms (2)

laparoscopic Nissen fundoplication

ACTIVE COMPARATOR

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

Procedure: Laparoscopic fundoplication

laparoscopic Toupet fundoplication

ACTIVE COMPARATOR

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

Procedure: Laparoscopic fundoplication

Interventions

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.

laparoscopic Nissen fundoplication; laparoscopic Toupet fundoplication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mykola Paranyak: lead

Study Sites (1)

Danylo Halytsky Lviv National Medical University

Lviv, 79010, Ukraine

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, assistant professor at the Department of General Surgery

Study Record Dates

• First Submitted: December 3, 2022
• First Posted: December 12, 2022
• Study Start: March 1, 2018
• Primary Completion: April 6, 2021
• Study Completion: April 6, 2021
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

UA (1)