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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05647668

Enrollment

120

Registered

2022-12-12

Start date

2018-03-01

Completion date

2021-04-06

Last updated

2022-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease

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.

Interventions

PROCEDURELaparoscopic fundoplication

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.
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.

Countries

Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026