NCT03143608

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

Laparoscopic Hiatal Hernia Repair Followed Immediately By Transoral Incisionless Fundoplication Using the Esophyx Device: Efficacy And Safety In 99 Patients In A Community Setting

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 99 (actual)
• Sponsor: Peter G Mavrelis · Individual
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

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 description

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

Conditions

• Gastro Esophageal Reflux

Interventions

Type	Name	Description
DEVICE	Esophyx	Laparoscopic hiatal hernia repair followed immediately by transoral incisionless fundoplication under general anesthesia using the Esophyx device

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2017-05-08
• Last updated: 2017-05-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study