Clinical trial: Laparoscopic Repair of Giant Hiatal Hernias With Nitinol-framed Lightweight Polytetrafluoroethylene Mesh (NCT01780285)

Eligibility criteria:
Inclusion Criteria:

          -  Type II and III hiatal hernias, including complicated by GERD,

          -  Able to undergo elective laparoscopic hiatal hernia repair,

          -  Able to 24 months follow-up with office examinations,

          -  Hiatal surface area (HSA) exceeding 20 sq.cm (by Granderath et al, 2007) which
             correspond to the diameter of hernia defect exceeding 8 cm (the distinct size is
             determined intraoperatively, those with smaller diameter will be excluded from the
             study),

          -  Nissen fundoplication (intraoperative criterion)

        Exclusion Criteria:

          -  Unable to undergo laparoscopic hiatal hernia repair due to: severe comorbidities (ASA
             III and more), previous major surgery with severe adhesions, etc.

          -  Cases of conversion to open surgery

          -  Age < 20 years and > 80 years

          -  BMI < 16 and > 39 kg/sq.m

          -  Pregnancy or plans for pregnancy within next 2 years (in females)

          -  Uncorrectable coagulopathy and immunosuppression

          -  Oesophageal motility disorders

          -  Oesophageal peptic strictures

          -  Oesophageal diverticula, other types (i.e. non-reflux) of chronic esophagitis,
             connective tissue disorders (e.g. scleroderma)

          -  Oesophageal shortening (determined intraoperatively as inability to achieve
             intra-abdominal length of oesophagus at least 3 cm in spite of intramediastinal
             oesophageal mobilization)

          -  Barrett's oesophagus

          -  History of oesophageal/gastric/duodenal surgery including vagotomy

          -  Relapsing course of ulcer disease/hyperacid gastritis including complicated by delayed
             gastric/duodenal emptying
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? 1