Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05712213
Status:
COMPLETED
Last Update Posted:
2023-02-06
First Post:
2023-01-25
Brief Title:
sIPOM vs pIPOM in Incisional Hernia Patients
Sponsor:
University of Campania Luigi Vanvitelli
Organization:
University of Campania Luigi Vanvitelli
Study Overview
Official Title:
Medium Terms Outcome of sIPOM vs pIPOM in Patients Affected by Incisional Hernia
Status:
COMPLETED
Status Verified Date:
2023-02
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:
Nowadays two intraperitoneal mesh approaches are commonly used in Laparoscopic Ventral Hernia Repair LVHR the simple intraperitoneal onlay mesh repair sIPOM and the intraperitoneal onlay mesh reinforcement with defect closure before placement of mesh pIPOM The pIPOM has been introduced to reduce adverse events in incisional hernia IH surgery ie seroma formation recurrences etc associated to laparoscopic hernia repair and satisfactory outcomes has been reported in several studies In details sequelae such mesh bulging seems to be less associated to pIPOM than sIPOM even if the latter topic is matter of intense debate The pIPOM has been introduced in the guidelines for the laparoscopic treatment of ventral and incisional abdominal wall hernias published by the International Endohernia Society IEHS in 2014 Despite prospective studies on the quality of IPOM-Plus are available the evidence level for the statements in these guidelines remains low The aim of this prospective analysis is to compare the postoperative outcomes of patients treated for Incisional hernia IH with sIPOM and pIPOM after 36 months follow-up in terms of recurrence and wound events
Detailed Description:
None
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