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NCT03797027
Effects of Abdominal Cushion on PCNL in Prone Position
NA trial testing Percutaneous Nephrolithotomy without an abdominal cushion in Kidney Stone in 180 participants. Status unknown.
1 January 2021
Quick facts
| Lead sponsor | The First Affiliated Hospital of Guangzhou Medical University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 180 |
| Start date | 1 January 2019 |
| Primary completion | 1 January 2021 |
| Estimated completion | 1 January 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Percutaneous Nephrolithotomy without an abdominal cushion
- Percutaneous Nephrolithotomy with an 5 cm abdominal cushion
- Percutaneous Nephrolithotomy with an 5 cm abdominal cushion
Conditions studied
- Kidney Stone — all drugs for Kidney Stone →
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Who can join
Adults 18 to 70, any sex, with Kidney Stone. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03797027
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03797027 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital of Guangzhou Medical University
- Last refreshed: 10 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03797027.
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