Gastro Esophageal Reflux Clinical Trial
Official title:
Laparoscopic Hiatal Hernia Repair Followed Immediately By Transoral Incisionless Fundoplication Using the Esophyx Device: Efficacy And Safety In 99 Patients In A Community Setting
The investigators prospectively studied ninety nine GERD patients following laparoscopic hiatal surgery combined with transoral incisionless fundoplication at two community hospitals. General surgeons and gastroenterologists participated in the study. GERD questions were recorded before and at six and twelve months.
GERD unresponsive to medical therapies can be treated by laparoscopic Nissen fundoplication
or endoluminal techniques. The investigators have extensive experience with Transoral
Incisionless Fundoplication(TIF). TIF is not indicated in patients with a hiatal hernia
larger than 2 cm. Performing a Hiatal Hernia Repair(HHR) in those cases will make a patient
eligible for TIF. HHR followed immediately by the TIF procedure under the same anesthetic
session is called a Hybrid-TIF (HTIF). The study examines the safety and efficacy of this
approach.
Prospective data were collected from patients who underwent HTIF at two 300 bed community
hospitals. Questionnaires were administered before the procedure, and mailed at 6 and 12
mos. They were the GERD-HRQL-health related quality of life, RSI-reflux symptom index, and
GSRS-gastrointestinal symptom rating scale.
The study continues with the new Esophyx-Z device
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