Clinical Trial: GERD Treatment With Transoral Incisionless Fundoplication (TIF) Following Hiatal Hernia Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Observational [Patient Registry]

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

Brief Summary: 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.

Detailed Summary:

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


Sponsor: Peter G Mavrelis

Current Primary Outcome:

  • Control of GERD symptoms [ Time Frame: one year ]
    GERD health related quality of life questionnaire
  • Control of GERD symptoms [ Time Frame: one year ]
    Reflux symptom index questionnaire
  • Control of GERD symptoms [ Time Frame: one year ]
    Gastrointestinal symptom rating scale


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mavrelis, Peter G., M.D.

Dates:
Date Received: April 29, 2017
Date Started: May 1, 2014
Date Completion:
Last Updated: May 5, 2017
Last Verified: May 2017