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临床试验/CTRI/2024/04/065508
CTRI/2024/04/065508尚未招募3 期

A comparative study between Supine and Prone Percutaneous Nephrolithotomy

Dr Devendra Singh Mehra1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年4月23日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
1. Operative time

研究概览

简要总结

Urolithiasis is a global disease with a prevalence rate of about 12% in Indian population and     out of which 50% may end up with loss of renal functions. PCNL (Percutaneous nephrolithotomy) stands as a gold standard surgical treatment for renal calculus disease. It has gradually replaced conventional open surgery for the removal of any size renal stone, specially large and complex one.

Since its first description by Fernstrom and Johansson in 1976, PCNL has traditionally been done with the patient prone, combining a high success rate and acceptable low morbidity.

The prone position has certain advantages like wide field of working area, easiness to puncture the calyx, shorter track length, ease of tract dilation, ease to do multiple punctures etc.But is associated with many problems like circulatory and ventilatory compromise because of compression on the chest especially in the obese patient; cervical spine injuries, tracheal compression and ocular injury during turning the patient; more fluid because of antigravity drainage of fluid.

Concurrent RIRS (Retrograde intrarenal surgery) is difficult in prone position. So there was a hunt in search of a new position which can ameliorate the disadvantages of traditional prone position.First original supine position was described by Valdivia et al. In this position the direction of the tract is downward and thus preserves a low pressure in the renal pelvis, and thereby reduces the risk of fluid absorption and allows spontaneous clearance/washout of fragments by gravity directed flow of fluid.The main limitation of this position is that the flank is not fully exposed, which makes initial puncture more difficult.

In 2007 The Galdakao-modified supine Valdivia position was described by Ibarluzea et al. for supine PCNL.

The aim is to compare the surgical outcomes between prone and supine PCNL.

This study will be done in patients who will be undergoing PCNL in urology department at RIMSH, Imphal, Manipur.

Study variables will include  age, gender,BMI,post operative haemoglobin drop,need for blood transfusion,mean operative time, number of patients developing complications,mean hospital stay,need for relook PCNL and stone free rate.

Patient will be evaluated with history, physical examination, urine analysis, urine culture and sensitivity, complete blood count, renal function tests, X-ray KUB, USG KUB, and Plain and contrast enhanced computed tomography / IVP.It is a convenience  non-probability sampling method where sample is collected from a group of people easy to reach or contact.After that patient who will be undergoing PCNL will be divided into two groups (Group A& Group B) which will be dicided by the cornerned operating surgeon.. Group A will undergo prone PCNL and Group B will undergo supine PCNL after obtaining anesthetic fitness for the procedure.

P-value <0.05 will be taken as statistically significant.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant Blinded

入排标准

年龄范围
12.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients presenting with lower calyceal and pelvic renal stone upto size 2cm.

排除标准

  • 1.Patients not willing to give consent to participate in the study.
  • 2.Paediatric age group (<12year ) 3.Bilateral stone disease.
  • 4.Previous history of PCNL or pyelolithotomy.
  • 5.Uncontrolled cougulopathy.
  • 6.Abnormal renal anatomy.

结局指标

主要结局

1. Operative time

时间窗: zero day(intra-operative).

2.Post op hemoglobin drop

时间窗: zero day(intra-operative).

3. Number of blood transfusions

时间窗: zero day(intra-operative).

4.Type of complications after procedure (if any)

时间窗: zero day(intra-operative).

次要结局

  • 1.Need for Relook PCNL(2.Duration of Hospital Stay)

研究者

发起方
Dr Devendra Singh Mehra
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Devendra Singh Mehra

RIMS,Imphal

研究点 (1)

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