Ignite Creation Date:
2024-05-06 @ 12:20 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03730233
Status:
COMPLETED
Last Update Posted:
2023-10-03
First Post:
2018-10-30
Brief Title:
Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing of the Diaphragmatic Hiatus A Randomized Double Blind Study With a 3-year Follow up
Status:
COMPLETED
Status Verified Date:
2023-10
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:
None
Brief Summary:
One-hundred and fifty-nine patients undergoing Nissen fundoplication for symptomatic gastro-oesophageal reflux disease GORD who had a concomitant hiatal hernia of 2 cm axial length were randomized to closure of the diaphragmatic hiatus with either crural sutures alone or tension-free closure with a non-absorbable mesh Primary outcome variable was the incidence of radiologically verified recurrent hiatal hernia Secondary outcomes were per-and postoperative complications and courses symptomatic recurrence rate use of PPI postoperative oesophageal acid exposure and Quality of Life
Detailed Description:
The basic principles behind successful surgical repair of the anatomy and function of the gastro-oesophageal junction GOJ in gastro-oesophageal reflux disease GORD is not only to encircle the distal oesophagus and GOJ by the fundic wrap but also to complete a transhiatal reduction of a concomitant hiatal hernia type I HH aiming for a 2 - 3 cm intra-abdominal length of the of oesophagus and to transact a tension-free hiatal closure The physiological and morphological characteristics of the diaphragmatic hiatus however carry a challenge for the selection of the ideal technique for surgical repair The diaphragmatic hiatus consists of a three-dimensional structure in constant motion which creates a border between the counteracting pressures prevailing in the abdominal and chest cavities respectively Following hernia reduction the structural quality of the diaphragmatic pillars is usually weak offering poor support for the subsequent closure with risk for high recurrence rates These and other considerations have encouraged the exploration of mesh reinforcement to enhance the durability of the hiatal closure
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