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Effects of Abdominal Cushion on PCNL in Prone Position

NCT03797027 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2019-01-10

No results posted yet for this study

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.

Conditions

  • Kidney Stone

Interventions

DEVICE

Percutaneous Nephrolithotomy without an abdominal cushion

patients undergo prone PNCL without an abdominal cushion

DEVICE

Percutaneous Nephrolithotomy with an 5 cm abdominal cushion

patients undergo prone PNCL with an 5 cm abdominal cushion

DEVICE

Percutaneous Nephrolithotomy with an 5 cm abdominal cushion

patients undergo prone PNCL with an 10 cm abdominal cushion

Sponsors & Collaborators

  • The First Affiliated Hospital of Guangzhou Medical University

    lead OTHER

Principal Investigators

  • Guohua Zeng, PH.D & MD · The First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-01-01
Completion
2021-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03797027 on ClinicalTrials.gov