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

NCT03150446 | Completed

• 1 other identifier: FC-DM 1.0
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Stones; Ureteral Calculus

Keywords

laparoscopy; ureteral catheterization

Outcome Measures

Primary Outcomes (1)

• upward malpositioning of ureteral stents

  whether the double-J stent was correctly placed in the bladder

  5 minutes

Study Arms (1)

The group using flexible cystoscopy

EXPERIMENTAL

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.

Device: flexible cystoscopy

Interventions

flexible cystoscopy 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 If the stent was well-placed, the flexible cystoscope was withdrawn.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.

Also known as: Laparoscopic adjustment of double-J stent

The group using flexible cystoscopy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sung Gu Kang: lead
• Korea University Anam Hospital: collaborator

Study Sites (1)

Department of Urology, Korea University College of Medicine

Seoul, 136-701, South Korea

Location

Related Publications (1)

• 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.

  PMID: 28619091 DERIVED

MeSH Terms

Conditions

Urinary Calculi; Ureteral Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ureterolithiasis; Ureteral Diseases

Study Officials

• Sung Gu Kang, Professor

  Department of Urology, Korea University College of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 12, 2017
• Study Start: April 1, 2009
• Primary Completion: June 30, 2015
• Study Completion: June 30, 2015
• Last Updated: May 12, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)