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

• Sponsor: Mykola Paranyak (Other)
• Overall Status: Completed
• CT.gov ID: NCT05647668
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 37.2
• Patients Per Site Per Month: 3.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease	Procedure: Laparoscopic fundoplication	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Trial on Laparoscopic Total vs Partial Fundoplication in Patients With Atypical Symptoms of Gastroesophageal Reflux Disease
• Actual Study Start Date: Mar 1, 2018
• Actual Primary Completion Date: Apr 6, 2021
• Actual Study Completion Date: Apr 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: laparoscopic Nissen fundoplication Creation of a 360° fundoplication wrap over a 30-Fr intra-esophageal bougie.	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.
Active Comparator: laparoscopic Toupet fundoplication Creation of a 270° fundoplication wrap over a 30-Fr intra-esophageal bougie.	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.

Outcome Measures

Primary Outcome Measures

1. Symptom scores of throat clearing, globus sensation, cough, throat pain, vocal changes. [24 month]

Secondary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Danylo Halytsky Lviv National Medical University	Lviv		Ukraine	79010

Sponsors and Collaborators

• Mykola Paranyak

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mykola Paranyak, MD, PhD, assistant professor at the Department of General Surgery, Danylo Halytsky Lviv National Medical University
• ClinicalTrials.gov Identifier: NCT05647668
• Other Study ID Numbers: 2708A
• First Posted: Dec 12, 2022
• Last Update Posted: Dec 13, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic

Study Results

No Results Posted as of Dec 13, 2022