OUTCOME OF RENAL STONE SURGERY WITH VERSUS WITHOUT TUBE INSERTION AFTER SURGERY

Phase 1

Not yet recruiting

• Conditions: Calculus of kidney,

• Registration Number: CTRI/2020/07/026933
• Lead Sponsor: SSSIHMS Puttaparthi

Brief Summary

Present study is a single institute, prospective study, with intention to compare and evaluate the effectiveness and safety of standard percutaneous nephrolithomy (PCNL) versus tubeless PCNL in the Department of Urology, Sri Sathya Sai Institute of Higher Medical Sciences – Prasanthigram, Anantapur, Andhra Pradesh. A minimum of 100 cases of renal stone disease that are willing to undergo PCNL will be included after taking written informed consent. Patients will be divided randomly into two groups involving minimum of 50 patients in each group. Group A patients will undergo Tubeless PCNL procedure and Group B patients will undergo Standard PCNL. The routine evaluation of patients enrolled in the study will be done as per the structured proforma. The efficacy and safety of the operative procedure will be analyzed based on postoperative pain score, analgesia requirement, fall in haemoglobin, blood transfusion requirement, duration of hematuria, duration of urine leak, duration of hospital stay and any other postoperative complications.The purpose of this study is to objectively compare the standard and tubeless PCNL depending on different variables and at the end of the study to provide guidance regarding preference of choice among the two methods in cases of nephrolithiasis.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-08
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Stone size more than 2 cm (any Guy’s stone score grade) 2.Single percutaneous tract 3.Complete stone clearance as assessed by intraoperative nephroscopy and fluoroscopy.

Exclusion Criteria

1.​Age less than 18 years and more than 50 years 2.​Residual calculi 3.​Significant bleeding at the end of procedure 4.​More than one percutaneous tract 5.​Preoperative deranged renal function tests 6.​History of previous surgery on ipsilateral urinary tract.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare postoperative pain and analgesia requirement	Every 6 hours after surgery upto period of discharge

Secondary Outcome Measures

Name	Time	Method
To compare	Operative time

Trial Locations

Locations (1)

SSSIHMS; 🇮🇳 Anantapur, ANDHRA PRADESH, India

SSSIHMS

🇮🇳Anantapur, ANDHRA PRADESH, India

Anuj Dumra

Principal investigator

8177000009

anujdumra@gmail.com