Clinical trial NCT03143608: GERD Treatment With Transoral Incisionless Fundoplication (TIF) Following Hiatal Hernia Surgery
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastro Esophageal Reflux
Keywords: GERD
Hiatal hernia repair
Transoral Incision less fundoplication
Lead sponsor: Mavrelis, Peter G., M.D.
Sponsor class: INDIV
First posted: 2017-05-08
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with GERD

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 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

Eligibility criteria: Inclusion Criteria:

* Patients with typical or atypical GERD who want a surgical solution to control symptoms.
* Patients need a 2-5 cm hiatal hernia and have a BMI of less than 36.

Exclusion Criteria:

* Hiatal hernias larger than 5 cm and BMI greater than 36.

Primary outcomes:
measure: Control of GERD symptoms
timeFrame: one year
measure: Control of GERD symptoms
timeFrame: one year
measure: Control of GERD symptoms
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Merrillville
country: United States
facility: Methodist Hospital
state: Indiana
city: Appleton
country: United States
facility: Affinity Health System
state: Wisconsin
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Peter Mavrelis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ihde GM, Besancon K, Deljkich E. Short-term safety and symptomatic outcomes of transoral incisionless fundoplication with or without hiatal hernia repair in patients with chronic gastroesophageal reflux disease. Am J Surg. 2011 Dec;202(6):740-6; discussion 746-7. doi: 10.1016/j.amjsurg.2011.06.035. Epub 2011 Oct 20.