Defining Pentafecta outcomes of miniPCNL (less than or equal to 22Fr) for renal stone (less than or equal to 3cms).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 281
- 试验地点
- 1
- 主要终点
- Primary : To standardize miniPCNL results on a quantifiable scale using a “Pentafecta of miniPCNLâ€
研究概览
简要总结
Patients will be operated under general anaesthesia.
Patients will be first placed in the lithotomy position for the placement of ureteric catheter and per-urethral catheter after which they will be turned prone.
Calyx will be punctured by initial puncture needle under fluoroscopic guidance. • A flexible 0.035†terumo guidewire was then inserted into the renal collecting system, preferably in the ureter or else in the upper pole calyx/second favorable calyx. The access needle was removed, and the skin and fascia were incised.
Tract dilatation will be done up to maximum of 22 French.
Stones will be fragmented by holmium/thulium laser.
Post lithotripsy, patients would be divided into three groups: DJ stented, Totally tubeless PCNL or with overnight Ureteric catheter.
Patients will be considered for Totally tubeless or with overnight Ureteric Catheter only in cases with no PCS injury, mild hematuria and no residual fragments on fluoroscopy.
Patients with larger stone burden/ PCS injury will be chosen for tubeless PCNL (Double J stent). Amplatz sheath will be removed after observing any hematuria or tract bleeding.
Intra-operative data will be recorded based on:
Number of tracts
Puncture Site
Tract Dilatation
Energy Used
External drainage
Post-op stone free status will be evaluated as per the standard of care, by follow-up NCCT KUB for residual stones at 4 weeks.
“Zero Stone Residue†(<1mm)
Clinically insignificant residual fragments(<4mm) [CIRF]
Clinically significant residual fragments(>4mm) [CSRF]
Complications will be classified according to Modified Clavien Dindo Classification.
eGFR will be calculated using the Cockroft-Gault formula using POD-1 and 1 month post op S.Creatinine levels (these blood tests are part of the routine work up of the patient and no extra tests are being done for the sake of the study).
Outcomes would be measured and used to compare.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients undergoing mini PCNL with stone size 1-3cms Age more than 18 years Willing to consent for study.
排除标准
- •Patients who opted for RIRS, ESWL.
- •Stone size > 3cms Age less than 18 years Contraindications for PCNL like pregnancy, bleeding diathesis, untreated urinary tract infection, tumor in the presumptive access tract area, and potential malignant kidney tumors.
结局指标
主要结局
Primary : To standardize miniPCNL results on a quantifiable scale using a “Pentafecta of miniPCNLâ€
时间窗: 4 weeks or one month
(i) Clinically Insignificant Stone Residue : <4mm seen on NCCT KUB done at 4 weeks.
时间窗: 4 weeks or one month
(ii) Modified Clavein dindo classification for complications (with significant being > or equal to Grade II)
时间窗: 4 weeks or one month
(iii) Tubeless/Totally Tubeless
时间窗: 4 weeks or one month
(iv) eGFR values : Pre-op, on Post-op day 1 and Post-op value at 4 weeks.
时间窗: 4 weeks or one month
(v) Ancillary procedure – within 1 month
时间窗: 4 weeks or one month
次要结局
- Comparing various methods of lithotripsy in achieving Pentafecta(4 weeks or one month)
研究者
Siddhant Kumar
KMC, Manipal