Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05807763
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-04-11
First Post:
2023-03-29
Brief Title:
Fundoplication in Laparoscopic PEH Repair Based on FLIP
Sponsor:
The Foundation for Surgical Innovation and Education
Organization:
The Foundation for Surgical Innovation and Education
Study Overview
Official Title:
Selective Use of Fundoplication in Laparoscopic Paraesophageal Hernia Repair Based on Intra-operative Impedance Planimetry FLIP
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEHFLIP
Brief Summary:
Prospective randomized controlled trial to identify a sub-set of patients that do not benefit from the routine addition and added morbidity of a fundoplication during laparoscopic paraesophageal hernia repair
Detailed Description:
Prospective Randomized Controlled Trial in which patients who meet criteria will be randomized to receive a concurrent fundoplication or no fundoplication at the time of paraesophageal hernia repair Patients with known objective gastroesophageal reflux disease prior to surgery those found to have a short esophagus in the operating room or defective gastroesophageal reflux barrier by intra-operative impedance planimetry measurements andor endoscopic valve grade will be excluded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None