Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06000020
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-21
First Post:
2023-08-14
Brief Title:
Leave or Laparoscopic Appendectomy With Normal Findings - a Regional Cohort Study
Sponsor:
Nordsjaellands Hospital
Organization:
Nordsjaellands Hospital
Study Overview
Official Title:
Leave or Laparoscopic Appendectomy With Normal Findings - a Regional Cohort Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
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:
Based on a regional cohort this study we will try to demonstrate the superiority of routine laparoscopic appendectomy vs leaving an intraoperative assessed normal appendix in situ in cases of normal findings at diagnostic laparoscopy If routine laparoscopic appendectomy is not superior we will recommend leaving the normal appendix in situ
Detailed Description:
The study is a retrospective cohort study with a superiority design It will be carried out at the surgical departments of the four public university hospitals providing emergency surgical service to the entire population of 18 million in the Capital Region of Denmark
On March 17 2017 a new electronic health record EHR had been implemented at three of the hospital while it was implemented at Copenhagen University Hospital - Bispebjerg on May 20 2017 These dates mark the start of the inclusion period for each hospital while the inclusion period ended April 1 2021 for all four hospitals
The snap boards covering the relevant operation rooms at the four hospitals will be systematically review For all cases where diagnostic laparoscopy was performed on suspicion of acute appendicitis the EHR will be reviewed
On March 17 2017 a new electronic health record EHR had been implemented at three of the hospital while it was implemented at Copenhagen University Hospital - Bispebjerg on May 20 2017 These dates mark the start of the inclusion period for each hospital while the inclusion period ended April 1 2021 for all four hospitals
The snap boards covering the relevant operation rooms at the four hospitals will be systematically review For all cases where diagnostic laparoscopy was performed on suspicion of acute appendicitis the EHR will be reviewed
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