Observation of complications of Percutaneous Nephrolithotomy (PCNL) procedure using Modified Clavien Grading System

Not yet recruiting

Conditions: Calculus of kidney with calculus of ureter,

Registration Number: CTRI/2018/10/016076

Lead Sponsor: Kasturba Medical College

Brief Summary: Title of the project: A prospective observational study ofcomplications of Percutaneous Nephrolithotomy (PCNL) using Modified ClavienGrading System

Type of Study: Prospective, single center, observationalstudy.

Objectives:

Primary: To evaluatethe postoperative complications of PCNL by using the Modified Clavien GradingSystem in patients of renal calculi/ upper ureteric calculi.

Secondary: To assess the variation in complication rateaccording to the varying patient factors, stone factors and the operativeprocedure.

Inclusion Criteria: All patients with renal calculi or upperureteric calculus who were planned to undergo PCNL.

Exclusion criteria: None.

Detailed description of procedure / processes:

All patients from the study population will undergo standardpreoperative evaluation.

Data collected will include patient demographics (Name, Age,Sex, BMI), their associated comorbidities and any history of previous surgeriesof the same kidney.

Laboratory investigations (Complete blood count, renalfunction tests, urine routine and culture) and Imaging findings (USG KUB/ X-rayKUB/ CT KUB/ IVP) of these patients shall be documented.

All patients will undergo CT (Plain or Contrast enhanced)KUB. Stone characteristics in relation to location, size, number, laterality,HU, associated Hydroureteronephrosis and stone burden as studied on CT shall benoted. Bone density, Aortic Calcification and Visceral fat shall also bedocumented from the CT scans.

Various stone scoring systems (S.T.O.N.E, GUY, CROES,S-ReSC) shall be applied.

Anatomic Variations on imaging like malrotated kidney,Horseshoe kidney, supernumerary kidney, duplex pelvicalyceal system or anyspinal anomalies shall be looked for.

Procedure specific variables like Supine PCNL or Prone PCNL,type of PCNL (Standard / MiniPCNL / Micro PCNL), number of punctures, Site ofpuncture (Superior/ Middle/ Inferior Calyx), Supracostal/ infracostal puncture,Primary and secondary tract size (Amplatz), Mode of stone fragmentation(Lithoclast, Laser, Mixed, Lithovac), Clearance of stone on endoscopy andfluoroscopy (total/ partial) shall be recorded.

Intraoperative parameters noted includes: amount of salineused, fluoroscopy time, stone fragmentation time, nephroscopy time, totalprocedure time, use of DJ stent/ Ureteric catheter, nephrostomy placement(suction catheter/ Malecots/ PCN tube), use of Flexible nephroscopy (if done),Ureteroscopy- Ipsilateral/contralateral/Bilateral (if done in the samesitting), or a Simultaneous Contralateral PCNL (if done)

Stone specimen shall be sent for analysis.

Postoperative parameters like pain (assessed by VisualAnalog Scale), Fever (37C/ 98.6F), or respiratory distress shall be looked for.At 6 hours postoperatively fall in Hemoglobin, rise in Total Leucocyte Countand Creatinine rise shall be measured. Need for blood transfusion, length ofhospital stay, symptoms/signs suggestive of adjacent organ injury or anincreasing perirenal hematoma on USG shall be noted.

Patients will be followed up after one month with USG KUB/X-ray KUB.

Outcome measures:

Complications observed postoperatively and in follow upshall be documented and shall be correlated with respective patient factors,stone factors and procedure specific factors

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

All patients between the age group of 5 to 95 years who are scheduled to undergo PCNL shall be included in the observational study.

Exclusion Criteria

Among the patients being posted for PCNL, no patients shall be excluded.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the post-operative complications of PCNL by using the modified Clavien Grading System in patients of renal calculi/ Upper ureteric calculi.	Immediate postoperative period and one month after surgery.

Secondary Outcome Measures

Name	Time	Method
To assess the variation in complication rates according to the varying patient factors, stone factors and the operative procedure.	Immediate Postoperative period and one month after surgery.

Trial Locations

Locations (1): Kasturba Medical College
🇮🇳
Udupi, KARNATAKA, India
Kasturba Medical College
🇮🇳Udupi, KARNATAKA, India
Akshay Kriplani
Principal investigator
8668955602
akshaykriplani@gmail.com