The 18F Peel-way Sheath Versus the 18F Access Sheath With a Suction-evacuation Function MPCNL for the Management of 2-5cm Size Kidney Stones

Sponsor
The First Affiliated Hospital of Guangzhou Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03206515
Collaborator
(none)
86
1
2
23
3.7

Study Details

Study Description

Brief Summary

Percutaneous nephrolithotomy (PNL) has been considered as the first-line choice for the management of >20mm kidney stones. Microchannel percutaneous nephrolithotomy (Mini PCNL) which takes nephrolithotomy channel size less than or equal to 18, was first used in the treatment of children with kidney stones in 1997, then gradually applied to adult, aims to achieve the similar stone clearance rate as the standard channels, at the same time, reduce the complications. At present, the use of percutaneous renal surgery in our country is more than 18F plastic peel-away sheath, with the access sheath with a suction-evacuation function was first used by Guohua Zeng and so on. But there is still a lack of high quality evidence of Evidence-based medical evidence to compare the two kinds of sheath for the safety and effectiveness. Therefore, this study provides a reliable theoretical basis for the choice of the sheath for the treatment of 2-5cm size Kidney, and ultimately benefit patients with 20mm.

Condition or Disease Intervention/Treatment Phase
  • Device: 18F Peel-Way Sheath
  • Device: 18F access sheath with a suction-evacuation function
N/A

Detailed Description

Percutaneous nephrolithotomy (PNL) has been considered as the first-line choice for the management of >20mm kidney stones. Microchannel percutaneous nephrolithotomy (Mini PCNL) which takes nephrolithotomy channel size less than or equal to 18, was first used in the treatment of children with kidney stones in 1997, then gradually applied to adult, aims to achieve the similar stone clearance rate as the standard channels, at the same time, reduce the complications. At present, the use of percutaneous renal surgery in our country is more than 18F plastic peel-away sheath, with the access sheath with a suction-evacuation function was first used by Guohua Zeng and so on. But there is still a lack of high quality evidence of Evidence-based medical evidence to compare the two kinds of sheath for the safety and effectiveness. Therefore, this study provides a reliable theoretical basis for the choice of the sheath for the treatment of 2-5cm size Kidney, and ultimately benefit patients with 20mm.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The 18F Peel-way Sheath Versus the 18F Access Sheath With a Suction-evacuation Function MPCNL for the Management of 2-5cm Size Kidney Stones: A Randomized Controlled Trial
Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: Group 1

Patients in Group 1 undergo Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath group

Device: 18F Peel-Way Sheath
Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath

Other: Group 2

Patients in Group 2 undergo Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function group

Device: 18F access sheath with a suction-evacuation function
Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function

Outcome Measures

Primary Outcome Measures

  1. The renal pelvic pressure [During the procedure]

    To measure the renal pelvic pressure during mini-PCNL procedure

Secondary Outcome Measures

  1. Perioperative complications [Intraoperatively or ≤ 1 month postoperatively]

    Invaluate perioperative complications by modified Clavien system

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients consent for percutaneous renal stone removal

  • Age 18 to 70 years

  • Normal renal function

  • ASA score Ⅰ and Ⅱ

  • Renal stones 20-50mm

Exclusion Criteria:
  • Patients with solitary kidney

  • Uncorrected coagulopathy and active urinary tract infection (UTI)

  • Morbid obese patients

  • Patients who underwent transplant or urinary diversion

  • Congenital abnormalities

  • Patients will be excluded from the study if the undergoing standard PNL/mini-perc have purulent fluid in the initial puncture

Contacts and Locations

Locations

Site City State Country Postal Code
1 epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong China 510230

Sponsors and Collaborators

  • The First Affiliated Hospital of Guangzhou Medical University

Investigators

  • Study Chair: Guohua Zeng, PH.D and M.D, The First Affiliated Hospital of Guangzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guohua Zeng, Vice President of the Hospital, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT03206515
Other Study ID Numbers:
  • MRER(17)2016
First Posted:
Jul 2, 2017
Last Update Posted:
Jul 2, 2017
Last Verified:
Jun 1, 2017
Keywords provided by Guohua Zeng, Vice President of the Hospital, The First Affiliated Hospital of Guangzhou Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 2, 2017