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

Mykola Paranyak

Status: Completed

Conditions: Gastroesophageal Reflux Disease

Treatments: Procedure: Laparoscopic fundoplication

Study type: Interventional

Funder types: Other

Identifiers

NCT05647668

2708A

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

laparoscopic Nissen fundoplication

Active Comparator group

Description:

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

Treatment:

Procedure: Laparoscopic fundoplication

laparoscopic Toupet fundoplication

Active Comparator group

Description:

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

Treatment:

Procedure: Laparoscopic fundoplication