Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA)... | NCT00821145

Studies
Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion

NCT00821145

Sponsor

Augusta Hospital Duesseldorf

Status

Withdrawn

Last Update Posted

Jul 12, 2012Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Infra and Juxtarenal Abdominal Aortic Aneurysms

Interventions

conventional surgery
laparoscopic AAA resection
laparoscopic stapler anastomosis

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

inability to recruit sufficient number of patients

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jun 2010Estimated

Completion Date

Jun 2010Estimated

First Submitted Date

Jan 8, 2009

First Submission Date that Met QC Criteria

Jan 12, 2009

First Posted Date

Jan 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2012

Last Update Posted Date

Jul 12, 2012Estimated

Name	Class
Storz GmbH FRG	UNKNOWN
Tel Aviv University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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 diet,postoperative ileus, total hospital stay, major and minor complications, blood loss, renal function in cases with juxtarenal AAA.Patients 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	50 patients operated using a conventional open surgery to exclude an abdominal aortic aneurysm	Procedure: conventional surgery
2	Experimental	50 patients operated using a total laparoscopic aortic aneurysm resection	Procedure: laparoscopic AAA resection
3	Active Comparator	25 patients using a laparoscopic approach for AAA resection with a stapled proximal anastomosis	Procedure: laparoscopic stapler anastomosis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
conventional surgery	Procedure	AAA patients operated using a conventional incision	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All cause mortality, reduced recovery postoperatively according to pain measurement, ICU and hospital stay, minor and major complications		1 year

Secondary Outcomes

Measure	Description	Time Frame
Use of a stapling device reduces total operative time and crossclamping period		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with abdominal aortic aneurysms
fit for open surgery

Exclusion Criteria:

patients unfit for open surgery
patients with malignancies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ralf R Kolvenbach, M.D.PhD	Augusta Hospital Duesseldorf	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017544	Aortic Aneurysm, Abdominal

Ancestor Terms

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

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