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

NCT ID: NCT03150446

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-01
• Study Completion Date: 2015-06-30

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.

Conditions

Urinary Stones; Ureteral Calculus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

The group using flexible cystoscopy

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.

Group Type: EXPERIMENTAL

flexible cystoscopy

Intervention Type: DEVICE

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.

Interventions

flexible cystoscopy

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.

Intervention Type: DEVICE

Other Intervention Names

Laparoscopic adjustment of double-J stent

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Korea University Anam Hospital

OTHER

Sponsor Role: collaborator

Sung Gu Kang

OTHER

Sponsor Role: lead

Responsible Party

Sung Gu Kang

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sung Gu Kang, Professor

Role: STUDY_DIRECTOR

Department of Urology, Korea University College of Medicine

Locations

Department of Urology, Korea University College of Medicine

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 28619091 (View on PubMed)

Other Identifiers

FC-DM 1.0

Identifier Type: -

Identifier Source: org_study_id