Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04838028
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2021-04-07
Brief Title:
Chronic Postoperative Pain After Laparoscopic Groin Hernia Repair
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Mesh and Fixation Combinations in Laparoscopic Groin Hernia Repair Association With Chronic Postoperative Pain A Swedish Hernia Registry Study
Status:
COMPLETED
Status Verified Date:
2022-11
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:
The study attempts to quantify the relative risks for chronic postoperative inguinal pain CPIP depending on different combinations of mesh and mesh fixation For this purpose the investigators will analyze data from the Swedish Hernia Registry SHR
Detailed Description:
This is an open cohort study design where the investigators will analyze existing data that have been prospectively collected in the Swedish Hernia Registry SHR which covers 95 of all groin hernia repairs in Sweden The very large cohort of approximately 25000 primary TEP totally extraperitoneal and TAPP transabdominal preperitoneal repairs enable assessment of the relative risks for CPIP depending on different combinations of mesh and mesh fixation Each participant was entered at the date of surgery when demographic and intraoperative data were registered The possible presence of CPIP after 1 year postoperative was evaluated with a PROM questionnaire
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?:
True
Is an FDA AA801 Violation?:
None