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A randomized controlled trial comparing infectious complications using mini perc with and without suction for renal stones less than 3 cm in size

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Abstract

The purpose was to do a study to compare infectious complications in patients operated for MiniPerc or Minimally invasive Percutaneous Nephrolithotomy (MPCNL) using MIP and MPCNL with suction using Shah Superperc sheath for medium-sized renal stones less than 3 cm in size. The primary objective of this study is to compare the infectious complications and the secondary objectives are to compare stone-free rates, complication rates and operative times. A prospective randomized controlled trial with patients having proximal ureteral and renal stones of 10–30 mm size and planned for MPCNL done at a single institute. A total of 80 consecutively admitted patients with written informed consent were included for randomization with 40 patients in each arm of MPCNL and suction MPCNL. The median age in MPCNL and suction MPCNL arms were 48 and 49 years, the median stone size of 15.45 and 16.7 cm, the Median stone volume of 1576.2 vs 1752 mm3, and the median stone density of 1258 and 1250 Hu, the median hospital stay of 3 days in both arms were comparable. Infectious complications were comparable in both arms. Operative time was significantly less in the suction MPCNL group (26.5 min–IQR 17–34.8) than in the MPCNL group (34.8 min–IQR 20–45), p = 0.021 and stone-free rates (SFR), were more in Suction MPCNL arm 97.5% than in MPCNL 87.5%, p = 0.04. Overall, the complication rates were comparable in both arms. Suction MPCNL procedure resulted in shorter operating times and more SFR than conventional MPCNL with comparable complication rates.

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Data availability

The datasets generated in the current study are available from the corresponding author upon reasonable request.

Abbreviations

MPCNL/miniPCNL/MiniPerc:

Minimally invasive percutaneous nephrolithotomy

EAU:

European Association of Urology

PCNL:

Percutaneous nephrolithotomy

Fr:

French

G:

Gauge

MIP:

Minimally invasive PCNL system

UTI:

Urinary tract infection

HU:

Hounsfield units

CT:

Computed tomography scan

TFL:

Thulium fiber laser

W:

Watts

J:

Joule

Hz:

Hertz

SP:

SuperPulse

DJ stent:

Double J stent

NCCT:

Non-Contrast CT

SOFA:

Sequential-sepsis-related- organ failure assessment

IRB:

Institutional Review Board

EC:

Ethical Committee

CONSORT:

Consolidated standards of reporting trials

RCT:

Randomised controlled trial

DM:

Diabetes mellitus

HTN:

Hypertension

IHD:

Ischemic heart disease

IQR:

Interquartile range

PCN:

Percutaneous nephrostomy

SFR:

Stone free rate

IRP/IPP:

Intrarenal pressure/intrapelvic pressure

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Acknowledgements

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Funding

No funding was received for conducting this study.

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Authors and Affiliations

  1. Urology Department, Muljibhai Patel Urological Hospital, Nadiad, Gujarat, India

    Niramya Pathak, Sahil Agrawal, Aditya Parikh, Nitiraj Shete, Abhishek Singh, Arvind Ganpule, Ravindra Sabnis & Mahesh Desai

Authors
  1. Niramya Pathak
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  2. Sahil Agrawal
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  3. Aditya Parikh
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  4. Nitiraj Shete
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  5. Abhishek Singh
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  6. Arvind Ganpule
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  7. Ravindra Sabnis
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  8. Mahesh Desai
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Contributions

Dr NP: protocol/project development, manuscript writing. Dr SA: data collection; Dr AP: data collection; Mr NS: data analysis; Dr AS: manuscript editing and review; Dr AG: manuscript editing and review; Dr RS: manuscript editing and review; Dr MD: manuscript editing and review. The manuscript has been read and approved by all the authors, the requirements for authorship have been met and each author believes that the manuscript represents honest work.

Corresponding author

Correspondence to Ravindra Sabnis.

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Conflict of interest

The authors declare that they have no conflicts of interest.

Ethics approval

The study was done as per the Good Clinical Practice Guidelines and as per the Guidelines in the Modified Declaration of Helsinki. Informed and written consent was obtained from all the participants. The protocol approval was obtained from the Institutional Review Board before study commencement (IRB No 15/2022) and the Ethical clearance was obtained from the Institutional Ethical Committee (841/2022).

Consent to participate

Informed written consent was obtained from all individual participants included in the study.

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Patients signed the informed written consent regarding publishing their data and photographs.

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Pathak, N., Agrawal, S., Parikh, A. et al. A randomized controlled trial comparing infectious complications using mini perc with and without suction for renal stones less than 3 cm in size. Urolithiasis 52, 6 (2024). https://doi.org/10.1007/s00240-023-01487-7

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