Evaluation of efficacy and safty of laparoscopic intravesical surgeries

UMIN ID: UMIN000001330

Registered date:01/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with lower urinary tract diseases of which intravesical surgeries are indicated for the treatments 1.Vesicoureteral reflux 2.Megaureter 3.Bladder diverticulum 4.Ureterocele 5.Hypogenesis of bladder neck etc.
• Date of first enrollment: 2010/06/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): After insertion of laparoscopic trocars, intravesical surgery is performed with insufflation of CO2 gas

Outcome(s)

• Primary Outcome: Adverse events
• Secondary Outcome: Postoperative improvement rate of diseases

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.Past history of intravesical surgery 2.Existence or past history of urothelial cancer 3.Severe complication such as heart or pulmonary disease 4.Active infection 5.Fever of 37.5 centigrade or higher 6.Pregnacy 7.Judged inappropriate with other reason by the project investigators

Related Information

• Primary Sponsor: Department of Urology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
• Source(s) of Monetary Support: None