Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00615888
Other study ID # 119/2005
Secondary ID
Status Completed
Phase N/A
First received February 1, 2008
Last updated January 13, 2010
Start date September 2005
Est. completion date March 2008

Study information

Verified date September 2005
Source University of Ulm
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

Fast track programs have been introduced in many surgical fields to minimize postoperative morbidity and mortality. Morbidity after elective open infrarenal aneurysm repair is as high as 30%, mortality ranges up to 10%. In terms of open infrarenal aneurysm repair no randomized controlled trials exist to introduce and evaluate such patient care programs.


Description:

Prospective randomization of patients admitted with infrarenal aortic aneurysm who undergo elective open repair in a "traditional" and "fast track" treatment arm. Main differences consist in preoperative bowel washout (none vs. 3L cleaning solution) and analgesia (patient controlled analgesia vs. patient controlled epidural analgesia: PCA vs. PCEA). Study endpoints are morbidity and mortality, need for postoperative mechanical ventilation and length of stay (LOS) on intensive care unit (ICU).


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 2008
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- infrarenal aortic aneurysm

- given written informed consent

Exclusion Criteria:

- contraindication for epidural anesthesia

- suprarenal clamping

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Fast track patient management
no bowel washout, patient controlled epidural anesthesia, early enteral feeding
Traditional management
preoperative bowel washout, patient controlled analgesia, delayed start of enteral feeding

Locations

Country Name City State
Germany University of Ulm Ulm

Sponsors (1)

Lead Sponsor Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Morbidity and mortality after open infrarenal aortic aneurysm repair 2 years Yes
Secondary LOS of ICU treatment, need for postoperative mechanical ventilation, day of discharge 2 years Yes
See also
  Status Clinical Trial Phase
Recruiting NCT04149600 - Identification of Genetic Causes of Calcific Aortic Valve Disease
Enrolling by invitation NCT04035356 - HAART Annuloplasty Device Valve Repair Registry
Recruiting NCT02729064 - Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose Phase 1
Completed NCT02467062 - Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease. N/A
Completed NCT02283307 - Dual Energy CT Urography With Reduced Iodinated Contrast N/A
Completed NCT01678261 - X-chromosome Inactivation, Epigenetics and the Transcriptome N/A
Terminated NCT01055275 - Cook Iliac Branch Graft Post-market Registry N/A
Completed NCT03510793 - Microcirculation and Anesthesia in Vascular Surgery
Completed NCT03207568 - RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU) N/A
Recruiting NCT05073991 - Incidence of Mortality and Complications After Lung Surgery, Open Thoracic Aortic Repair, TEVAR, EVAR.
Completed NCT02000544 - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit N/A
Not yet recruiting NCT01918969 - Reference Values of Circulating Endothelial Progenitor Cells N/A
Not yet recruiting NCT01918982 - Circulating Endothelial Progenitor Cells and Aortic Aneurysm N/A
Completed NCT01256372 - An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery Phase 2
Recruiting NCT00661518 - PET/CT Imaging of Aneurysm Wall Inflammation N/A
Completed NCT00094575 - Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA) Phase 4
Recruiting NCT04471909 - NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness N/A
Recruiting NCT05603520 - Phenotyping Heterogeneity and Regionality of the Aorta
Completed NCT03727542 - Influence of Short AV Delay Permanent Pacing on Matrix Metalloproteinase Levels N/A
Not yet recruiting NCT05531084 - Safety and Effectiveness of Surgeon-Modified Stent Grafts forTreatment of Complex Aortic Aneurysms N/A