NCT03797027

Brief Summary

Percutaneous nephrolithotomy (PCNL) is the first choice for the treatment of ≥ 2cm renal stones. The positions of PCNL includes supine, prone and lateral. PCNL has been performed in my center for nearly twenty years. The prone position is routinely used. Generally speaking, an abdominal cushion is used to raise the abdominal in the prone position, in order to provide an adequate exposure of kidney, increase the intercostal space, decrease the mobility of kidney and lower the risk of pleura injury. However, there is no consensus and criterion on the height of abdominal cushion. With largely increased PCNL procedures and various BMI, precise evaluation of abdominal cushion is needed. In the preliminary work, the investigators measured the sunken height of waist of 100 patients in the prone position without a abdominal cushion. The results showed that the mean BMI of 100 patients was 23.45 (16.79-36.98) and the range of sunken height of waist was 2-7 cm. Therefore, the investigators are planning to conduct a randomized controlled study to compare the safety and efficacy among no cushion group, 5 cm cushion group and 10 cm cushion group. To clarify the relationship between height of abdominal cushion and BMI, the nurse could prepare the appropriate cushion the day before surgery, which would decrease operating time and accelerate postoperative recovery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

January 5, 2019

Last Update Submit

January 9, 2019

Conditions

Kidney Stone

Keywords

Percutaneous nephrolithotomycushion

Outcome Measures

Primary Outcomes (1)

  • time of puncture and dilation

    intraoperatively

Study Arms (3)

No cushion

OTHER

Patients in no cushion group undergo prone percutaneous nephrolithotomy without an abdominal cushion

Device: Percutaneous Nephrolithotomy without an abdominal cushion

5 cm cushion

OTHER

Patients in 5 cm cushion group undergo prone percutaneous nephrolithotomy with an 5 cm abdominal cushion

Device: Percutaneous Nephrolithotomy with an 5 cm abdominal cushion

10 cm cushion

OTHER

Patients in 10 cm cushion group undergo prone percutaneous nephrolithotomy with an 10 cm abdominal cushion

Device: Percutaneous Nephrolithotomy with an 5 cm abdominal cushion

Interventions

Percutaneous Nephrolithotomy without an abdominal cushionDEVICE

patients undergo prone PNCL without an abdominal cushion

No cushion
Percutaneous Nephrolithotomy with an 5 cm abdominal cushionDEVICE

patients undergo prone PNCL with an 5 cm abdominal cushion

5 cm cushion

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing to receive PCNL
  • Aged 18-70 years
  • Normal renal function
  • ASA scoreⅠ to Ⅱ

You may not qualify if:

  • Uncorrected coagulopathy and active urinary tract infection (UTI)
  • Patients who underwent transplant or urinary diversion.
  • Congenital abnormalities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510230, China

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Interventions

Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LaparoscopyEndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Guohua Zeng, PH.D & MD

    The First Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guohua Zeng, PH.D & MD

CONTACT

+86 13802916676gzgyzgh@vip.tom.com

Chao Cai, PH.D & MD

CONTACT

+86 13512780911673059209@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president

Study Record Dates

First Submitted

January 5, 2019

First Posted

January 8, 2019

Study Start

January 1, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

CN(1)