Role of Flexible Cystoscopy in Laparoscopic Stone Surgery

Kidney Calculi; Ureteral Calculi Clinical Trial

Official title:

The Role of Flexible Cystoscopy in Laparoscopic Stone Surgery: a Single Surgeon Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277198
• Other study ID #: lapastone
• Secondary ID: flexible cysto i
• Status: Completed
• Phase: N/A
• First received: January 13, 2011
• Last updated: January 13, 2011
• Start date: January 2005
• Est. completion date: August 2010

Study information

• Verified date: January 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Authors want to investigate the usefulness of flexible cystoscopy in performing laparoscopic pyelolithotomies and ureterolithotomies by comparing operative results of a single surgeon's experience.

Description:

Previous trials to increase stone clearance rates have been recently reached using flexible equipment in laparoscopic surgery, however, it is not clear whether using flexible equipment is really helpful in performing pyelolithotomies and the clearance rates using flexible equipment varies 71% to 100%. Therefore, authors plan to investigate the usefulness of flexible cystoscopy in performing laparoscopic pyelolithotomies and ureterolithotomies by comparing operative results of a single surgeon's experience.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients with complex renal stones and large or impacted ureter stones

• patients who underwent laparoscopic pyelolithotomies with concomitant calyceal stone removal or ureterolithotomy using a flexible cystoscopy or not

Exclusion Criteria:

• active infection, uncontrolled bleeding tendency, previous abdominal surgery

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Calculi; Ureteral Calculi
• Ureteral Calculi
• Ureterolithiasis

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Boramae Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the presence of residual stones	We judged the success when there is no residual stone in the intravenous pyelogram at 12 weeks postoperatively	intravenous pyelogram at 12 weeks postoperatively	No
Secondary	stone numbers and sizes, surgical approach, insertion of a DJ ureteral catheter, and use of a flexible cystoscopy, etc	Preoperative evaluation included a complete history, physical examination, and imaging work-up such as X-ray or computed tomography (CT). Mean preoperative stone numbers and sizes were evaluated and we also evaluated operative information such as surgical approach, insertion of a DJ ureteral catheter, and use of a flexible cystoscopy	Retrospective review of data	No