Clinical Trials Logo

Clinical Trial Summary

This monocenter randomized controlled trial aims to compare postoperative outcomes of a laparoscopic valvuloplasty with a Toupet fundoplication in patients with GERD with a maximum hiatal hernia of 3cm. In addition, an economic evaluation of the new intervention will be done in order to determine cost-effectiveness and costs per quality-adjusted life-year (QALY).


Clinical Trial Description

This is a prospective, interventional, double-blinded, monocenter randomized controlled trial comparing a laparoscopic gastroesophageal valvuloplasty to laparoscopic Toupet fundoplication in patients with proven GERD with a maximum hiatal hernia of 3cm. In this design, both patient and researcher are blinded to the treatment allocation.

Block randomization will be used to ensure an equal number in each treatment arm. Block randomization works by randomizing participants within blocks such that an equal number are assigned to each treatment. To reduce selection bias by predictability of the treatment allocation, random block sizes are used. Also the investigator is kept blind to the size of each block. A computer is used to generate 15 blocks for each participating center with random block sizes of 4, 8 and 12. Allocation proceeds by randomly selecting one of the orderings and assigning the next block of participants to study groups according to the specified sequence.

Patients will be included during a two-year period and followed for a minimum of one year. When a patient is referred to a participating surgeon for antireflux surgery, he or she will receive study information to give them sufficient time for consideration. The surgeon will ensure all required pre-operative diagnostic tests are performed and that the indication for surgery is valid. During a follow-up visit, the surgeon ascertains that the patient complies with all inclusion criteria and does not meet any of the exclusion criteria. Study participation will be discussed and after informed consent is obtained, the patient will be included in the trial.

After inclusion, the patient is immediately randomized but treatment allocation is not yet shared with the surgeon. The patient will receive validated questionnaires to record the pattern of symptoms, quality of life, medication and medical care usage. Data from the pre-operative tests will be recorded.

On the day of surgery, the surgeon will be able to see treatment allocation and after performing the appropriate surgical procedure, records the course and specifics of the surgical procedure. Patients will receive a diary to record their meals and symptoms.

Follow-up in the outpatient clinic will take place at the surgeon's discretion. At fixed moments: 3, 6 and 12 months after surgery, the patients will once more receive validated questionnaires. Also at about three months, a follow-up manometry and 24-hour pH and/or impedance monitoring will be performed.

A power analysis was performed to calculate the sample size. Our primary aim was to compare the effect of both surgical procedures. Based upon the current medical literature, the objective/subjective success rate for the laparoscopic Toupet fundoplication is around 88%. Pilot data from a retrospective cohort of patients that underwent valvuloplasty report a subjective success rate of 96%. Our hypothesis was that the gastroesophageal valvuloplasty is not inferior to the Toupet fundoplication when comparing its effects on acid control.

To prove non-inferiority of the valvuloplasty regarding acid reflux control, using a non-inferiority limit of 5%, 73 patients are required in each group. In all power calculations, a significance of 5% and power of 90% was used.

To accommodate for a loss to follow-up of up to 10 percent, a total sample size of 160 was chosen. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02625077
Study type Interventional
Source Meander Medical Center
Contact
Status Withdrawn
Phase N/A
Start date January 2016
Completion date January 2019

See also
  Status Clinical Trial Phase
Recruiting NCT05561179 - Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease N/A
Withdrawn NCT02213887 - Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications Phase 4
Completed NCT01946971 - Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER) Phase 1/Phase 2
Recruiting NCT01825473 - Study of Erythromycin in GER-Associated Apnea of the Newborn N/A
Completed NCT00614536 - Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period Phase 4
Completed NCT00365300 - Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD) Phase 3
Completed NCT00284908 - Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers Phase 1
Completed NCT00373997 - Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Phase 4
Completed NCT00141960 - Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease Phase 2/Phase 3
Completed NCT00215787 - Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease N/A
Completed NCT01167543 - Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease N/A
Completed NCT00291746 - Validation of RDQ Questionnaire Phase 4
Completed NCT00567021 - German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms N/A
Completed NCT00226044 - Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants. Phase 3
Completed NCT00181805 - Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
Completed NCT01048840 - Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age
Terminated NCT01281553 - A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease Phase 4
Completed NCT05486169 - Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy N/A
Completed NCT04034017 - Gastroesophageal Reflux Disease Among College Students
Terminated NCT03226054 - Determining Risk Factors for Successful PPI Weaning N/A