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The Usefulness of Flexible Cystoscopy for Preventing Double-J Stent Malposition After Laparoscopic Ureterolithotomy (FC-DM)

Primary Purpose

Urinary Stones, Ureteral Calculus

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
flexible cystoscopy
Sponsored by
Sung Gu Kang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Stones focused on measuring laparoscopy, ureteral catheterization

Eligibility Criteria

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Inclusion Criteria:

  • the patients with large stones (>1.8 cm in size) of the upper ureter
  • male patients

Exclusion Criteria:

  • the patients planing to be treated with other treatment except laparoscopic ureterolithotomy about the upper ureter stone
  • female patients
  • non operable patients

Sites / Locations

  • Department of Urology, Korea University College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The group using flexible cystoscopy

Arm Description

50 patients with large upper ureteral stones underwent laparoscopic ureterolithotomy with flexible cystoscopy to confirm the correct positioning of the double-J stent. After intracorporeal insertion of the double-J catheter, additional endoscopic monitoring with flexible cystoscopy was performed. The surgeon manipulating the double-J catheter used monitor A, while an assistant inserted a flexible cystoscope into the bladder through the urethral route and determined whether the double-J stent was correctly placed in the bladder using monitor B before suturing the site of ureterotomy.

Outcomes

Primary Outcome Measures

upward malpositioning of ureteral stents
whether the double-J stent was correctly placed in the bladder

Secondary Outcome Measures

Full Information

First Posted
May 5, 2017
Last Updated
May 10, 2017
Sponsor
Sung Gu Kang
Collaborators
Korea University Anam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03150446
Brief Title
The Usefulness of Flexible Cystoscopy for Preventing Double-J Stent Malposition After Laparoscopic Ureterolithotomy
Acronym
FC-DM
Official Title
The Usefulness of Flexible Cystoscopy for Preventing Double-J Stent Malposition After Laparoscopic Ureterolithotomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2009 (Actual)
Primary Completion Date
June 30, 2015 (Actual)
Study Completion Date
June 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sung Gu Kang
Collaborators
Korea University Anam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study was to evaluate the role of flexible cystoscopy in preventing malpositioning of the ureteral stent after laparoscopic ureterolithotomy in male patients. From April 2009 to June 2015, 97 male patients with stones >1.8 cm in the upper ureter underwent intracorporeal double-J stenting of the ureter after laparoscopic ureterolithotomy performed by four different surgeons. In the last 50 patients who underwent laparoscopic ureterolithotomy flexible cystoscopy was performed through the urethral route to confirm the position of the double-J stent, while in the first 47 correct positioning of the stent was confirmed through postoperative KUB.
Detailed Description
The treatment of large upper ureteral stones is still controversial. The American Urological Association (AUA) and the European Association of Urology (EAU) recommend that laparoscopic stone removal may be considered in rare cases in which shockwave lithotripsy (SWL), ureteroscopic lithotripsy (URS), and percutaneous nephrolithotomy fail or are unlikely to be successful. In a recent meta-analysis of treatment of large proximal ureteral stones, Torricelli et al. reported that the outcomes of laparoscopic ureterolithotomy (LUL) for larger upper ureteral stones are favorable compared with those of URS, and LUL should be considered as a first-line option when flexible ureteroscopy is not available. After such surgery, many surgeons prefer placing a double-J stent, a ureteral catheter that is passed through the ureter from the kidney to the bladder. Although double-J stent placement after LUL remains controversial, many urologists believe that it may help prevent postoperative urinary leakage. Intracorporeal double-J stenting is technically difficult, and malpositioning often occurs after surgery in clinical practice. However, the actual rate of malpositioning of stents has not been reported yet. Although clinicians use different ways to place double-J stents precisely, accurate stent placement before the closure of the ureteral incision might be difficult to confirm. Upward malpositioning of the stent after surgery may necessitate removal of the stent using a ureteroscope. It is difficult to remove stents in the outpatient setting without anesthesia to reduce pain and discomfort, especially in male patients. In this study, The investigators used flexible cystoscopy through the urethral route before closure of the ureteral incision to confirm that the double-J stent was placed correctly in the bladder of male patients. Upon identification of upward malpositioning of the ureteral stent, position adjustments were performed by intracorporeally manipulating the ureteral stent through the incision site of the ureter. The aim of this study was to determine the malpositioning rate and predicting factors associated with upward malpositioning of intracorporeal double-J stents after LUL and to evaluate the usefulness of flexible cystoscopy in preventing such malpositioning in male patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stones, Ureteral Calculus
Keywords
laparoscopy, ureteral catheterization

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
From April 2009 to June 2015, 97 male patients with stones >1.8 cm in the upper ureter underwent intracorporeal double-J stenting of the ureter after laparoscopic ureterolithotomy performed by four different surgeons. The 50 participants was performed with flexible cystoscopy through the urethral route to confirm the position of the double-J stent.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The group using flexible cystoscopy
Arm Type
Experimental
Arm Description
50 patients with large upper ureteral stones underwent laparoscopic ureterolithotomy with flexible cystoscopy to confirm the correct positioning of the double-J stent. After intracorporeal insertion of the double-J catheter, additional endoscopic monitoring with flexible cystoscopy was performed. The surgeon manipulating the double-J catheter used monitor A, while an assistant inserted a flexible cystoscope into the bladder through the urethral route and determined whether the double-J stent was correctly placed in the bladder using monitor B before suturing the site of ureterotomy.
Intervention Type
Device
Intervention Name(s)
flexible cystoscopy
Other Intervention Name(s)
Laparoscopic adjustment of double-J stent
Intervention Description
After intracorporeal insertion of the double-J catheter, additional endoscopic monitoring with flexible cystoscopy was performed. The surgeon manipulating the double-J catheter used monitor A, while an assistant inserted a flexible cystoscope into the bladder through the urethral route and determined whether the double-J stent was correctly placed in the bladder using monitor B before suturing the site of ureterotomy. If the stent was well-placed, the flexible cystoscope was withdrawn. If the double-J stent was not visualized in the bladder, the surgeon pushed the stent inferiorly using a laparoscopic instrument and monitor A until the stent came out through the ureteral orifice on monitor B.
Primary Outcome Measure Information:
Title
upward malpositioning of ureteral stents
Description
whether the double-J stent was correctly placed in the bladder
Time Frame
5 minutes

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: the patients with large stones (>1.8 cm in size) of the upper ureter male patients Exclusion Criteria: the patients planing to be treated with other treatment except laparoscopic ureterolithotomy about the upper ureter stone female patients non operable patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Gu Kang, Professor
Organizational Affiliation
Department of Urology, Korea University College of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Department of Urology, Korea University College of Medicine
City
Seoul
ZIP/Postal Code
136-701
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28619091
Citation
Kim JY, Kang SH, Cheon J, Lee JG, Kim JJ, Kang SG. The usefulness of flexible cystoscopy for preventing double-J stent malposition after laparoscopic ureterolithotomy. BMC Urol. 2017 Jun 15;17(1):44. doi: 10.1186/s12894-017-0232-4.
Results Reference
derived

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The Usefulness of Flexible Cystoscopy for Preventing Double-J Stent Malposition After Laparoscopic Ureterolithotomy

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