Ignite Creation Date:
2024-05-05 @ 9:09 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00821145
Status:
WITHDRAWN
Last Update Posted:
2012-07-12
First Post:
2009-01-08
Brief Title:
Laparoscopic Versus Open Abdominal Aortic Aneurysm AAA Exclusion
Sponsor:
Augusta Hospital Duesseldorf
Organization:
Augusta Hospital Duesseldorf
Study Overview
Official Title:
Laparoscopic Aortic Resection Versus Open Surgery in Patients With AAA
Status:
WITHDRAWN
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
inability to recruit sufficient number of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LapAorta
Brief Summary:
In many countries the gold standard for treating abdominal aortic aneurysms is still open surgery with a long incision In patients with suitable anatomy alternatively an endovascular approach can be chosen Since open surgery is more durable in many countries a laparoscopic procedure using key hole surgery has gained wider acceptance The current study wants to prove that laparoscopic aortic aneurysm procedures are less invasive than open surgery with reduced recovery times
Detailed Description:
In many countries the gold standard for treating abdominal aortic aneurysms is still open surgery with a long incision In patients with suitable anatomy alternatively an endovascular approach can be chosen Since open surgery is more durable in many countries a laparoscopic procedure using key hole surgery has gained wider acceptance The current study wants to prove that laparoscopic aortic aneurysm procedures are less invasive than open surgery with reduced recovery times
Study design Multi center prospective randomized study including patients with infra or juxtarenal aortic aneurysms AAA
In group I the AAA is resected using a conventional long incision and standard procedures for resecting the AAA A Dacron graft is used in inlay technique to restore blood flow
In group II a total laparoscopic approach is chosen to exclude the AAA Identical to open surgery a dacron graft is laparoscopically sawn in to exclude the AAA and to restore blood flow
In a subgroup II a the laparoscopic anastomosis is performed with a stapling device to simplify and to accelerate the procedure
Endpoints of the study
Total operating time aortic crossclamping time stay in ICU return to a regular dietpostoperative ileus total hospital stay major and minor complications blood loss renal function in cases with juxtarenal AAAPatients are evaluated for postoperative pain wound related problems hernias and time until full mobilisation is achieved
Hypothesis The laparoscopic approach though associated with a longer operating time and longer clamping times is associated with a reduced recovery time les pain and less wound related problems compared to a full length conventional incision
Study design Multi center prospective randomized study including patients with infra or juxtarenal aortic aneurysms AAA
In group I the AAA is resected using a conventional long incision and standard procedures for resecting the AAA A Dacron graft is used in inlay technique to restore blood flow
In group II a total laparoscopic approach is chosen to exclude the AAA Identical to open surgery a dacron graft is laparoscopically sawn in to exclude the AAA and to restore blood flow
In a subgroup II a the laparoscopic anastomosis is performed with a stapling device to simplify and to accelerate the procedure
Endpoints of the study
Total operating time aortic crossclamping time stay in ICU return to a regular dietpostoperative ileus total hospital stay major and minor complications blood loss renal function in cases with juxtarenal AAAPatients are evaluated for postoperative pain wound related problems hernias and time until full mobilisation is achieved
Hypothesis The laparoscopic approach though associated with a longer operating time and longer clamping times is associated with a reduced recovery time les pain and less wound related problems compared to a full length conventional incision
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None