GERD Treatment With Transoral Incisionless Fundoplication (TIF) Following Hiatal Hernia Surgery
GERD
Laparoscopic Hiatal Hernia Repair Followed Immediately By Transoral Incisionless Fundoplication Using the Esophyx Device: Efficacy And Safety In 99 Patients In A Community Setting
1 other identifier
observational
99
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2014
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2016
CompletedFirst Submitted
Initial submission to the registry
April 29, 2017
CompletedFirst Posted
Study publicly available on registry
May 8, 2017
CompletedMay 8, 2017
May 1, 2017
2.7 years
April 29, 2017
May 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Control of GERD symptoms
GERD health related quality of life questionnaire
one year
Control of GERD symptoms
Reflux symptom index questionnaire
one year
Control of GERD symptoms
Gastrointestinal symptom rating scale
one year
Study Arms (2)
Indiana group
50 adult patients males and females with GERD and 2-5 cm hiatal hernias. Each had laparoscopic hiatal hernia repair followed by transoral incisionless fundoplication
Wisconsin group
49 adult patients males and females with GERD and 2-5 cm hiatal hernias. Each had laparoscopic hiatal hernia repair followed by transoral incisionless fundoplication
Interventions
Laparoscopic hiatal hernia repair followed immediately by transoral incisionless fundoplication under general anesthesia using the Esophyx device
Eligibility Criteria
Adults with GERD
You may qualify if:
- 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.
You may not qualify if:
- Hiatal hernias larger than 5 cm and BMI greater than 36.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peter G Mavrelislead
Study Sites (2)
Methodist Hospital
Merrillville, Indiana, 46410, United States
Affinity Health System
Appleton, Wisconsin, 54915, United States
Related Publications (1)
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.
PMID: 22014853RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Mavrelis, MD
The Methodist Hospital Research Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- INDIV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Gastroenterologist
Study Record Dates
First Submitted
April 29, 2017
First Posted
May 8, 2017
Study Start
May 1, 2014
Primary Completion
December 31, 2016
Study Completion
December 31, 2016
Last Updated
May 8, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share
presentation at national meeting