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

NCT ID: NCT05647668

Last Updated: 2022-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2021-04-06

Brief Summary

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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

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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laparoscopic Nissen fundoplication

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

Group Type ACTIVE_COMPARATOR

Laparoscopic fundoplication

Intervention Type 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 Toupet fundoplication

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

Group Type ACTIVE_COMPARATOR

Laparoscopic fundoplication

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mykola Paranyak

OTHER

Sponsor Role lead

Responsible Party

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Mykola Paranyak

MD, PhD, assistant professor at the Department of General Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Danylo Halytsky Lviv National Medical University

Lviv, , Ukraine

Site Status

Countries

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Ukraine

Other Identifiers

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2708A

Identifier Type: -

Identifier Source: org_study_id