Prospective Double-Blind Study for the Use of Aspirin During Transurethral Surgery of the Bladder or the Prostate

This study is ongoing, but not recruiting participants.

First Received: March 12, 2009 No Changes Posted

Sponsored by:	University Hospital, Basel, Switzerland
Information provided by:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00861367

Purpose

Aspirin is very common in older patients. Therefore many of the investigators patients have aspirin. The aim of the study is to proof that Transurethral Surgery of the bladder or the prostate can be performed with aspirin.

Condition	Intervention
Blood Loss,Surgical; Intraoperative Complications; Reoperation Rates in Patients With Aspirin Treatment;	Drug: transurethral surgery with or without aspirin

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospektive Doppel-Blind-Randomisierte Studie Zur Verwendung Von Aspirin Bei Transurethralen Operationen

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Acetylsalicylic acid

U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:

Blood loss [ Time Frame: intraoperative, 6 hours post op, 3 days postop ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Reoperation rates [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	124
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator aspirin 100mg	Drug: transurethral surgery with or without aspirin aspirin 100mg once a day, transurethral surgery with or without aspirin
2: Placebo Comparator empty capsule	Drug: transurethral surgery with or without aspirin aspirin 100mg once a day, transurethral surgery with or without aspirin

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Transurethral surgery of the bladder or prostate, informed consent, age over 18

Exclusion Criteria:

Oral anticoagulation,

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861367

Locations

Switzerland
Urologische Universitätsklinik Basel-Liestal
Liestal, Switzerland, 4410

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Study Chair:

thomas C Gasser, Prof

Department of Urology, Liestal

More Information

No publications provided

Responsible Party:	Department of Urology, Kantonsspital Liestal ( Maurer Patrick/Dr. )
Study ID Numbers:	05/08
Study First Received:	March 12, 2009
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00861367 History of Changes
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:

aspirin
blood loss
transurethral surgery

Study placed in the following topic categories:

Anti-Inflammatory Agents
Cyclooxygenase Inhibitors
Blood Loss, Surgical
Fibrinolytic Agents
Cardiovascular Agents
Hemorrhage
Intraoperative Complications
Fibrin Modulating Agents

Aspirin
Analgesics, Non-Narcotic
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Fibrinolytic Agents
Blood Loss, Surgical
Cardiovascular Agents
Hemorrhage
Intraoperative Complications
Pharmacologic Actions

Fibrin Modulating Agents
Pathologic Processes
Aspirin
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009