Low Pressure Versus Standard Pressure Pneumoperitoneum in Laparoscopic Nephrectomy

Study Overview
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Brief Summary
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Laparoscopic nephrectomies are commonly performed these days and are considered gold standard for both benign and malignant diseases as well as for donor nephrectomies. Despite being a widely performed surgery worldwide still there are areas of uncertainties due to lack of evidences. One of such area of dilemma is the optimum pressure of pneumoperitoneum. This study aims to identify if lower pressure of pneumoperitoneum is safe during laparoscopic nephrectomies. This is a hospital based prospective randomized control study. All the patients undergoing laparoscopic nephrectomies at department of urology and kidney transplant surgery will be eligible for study. Patients will be divided into low pressure or standard pressure pneumoperitoneum by simple random sampling and comparison of various intraoperative and post-operative parameters will be done to assess the safety of low pressure pneumoperitoneum

Official Title
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Low Pressure Versus Standard Pressure Pneumoperitoneum in Laparoscopic Nephrectomy: A Prospective Randomised Controlled Trial

Conditions
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Non-Functioning Kidney, Renal Cell Carcinoma

Intervention / Treatment
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* Procedure: Laparoscopic Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing laparoscopic nephrectomy Exclusion Criteria: Age <18 years History of previous abdominal surgeries Laparoscopic donor nephrectomies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low pressure pneumoperitoneum laparoscopic nephrectomy<br>Pneumoperitonuem Pressure of 8 - 10 mmHg | Procedure: Laparoscopic Surgery<br>* Surgery will then proceed at either 8 - 10 or 12 - 15 mmHg pneumoperitoneum pressure depending on study group the patient falls into Port Placement Reflection of colon Isolation of ureterogonadal packet Upper pole dissection Hilar dissection Vessel clipping and division Dissection of kidney Delivery through either Pfannenstiel or iliac fossa incision<br>|
| Active Comparator: Standard pressure pneumoperitoneum laparoscopic nephrectomy<br>Pneumoperitonuem Pressure of 12 - 15 mmHg | Procedure: Laparoscopic Surgery<br>* Surgery will then proceed at either 8 - 10 or 12 - 15 mmHg pneumoperitoneum pressure depending on study group the patient falls into Port Placement Reflection of colon Isolation of ureterogonadal packet Upper pole dissection Hilar dissection Vessel clipping and division Dissection of kidney Delivery through either Pfannenstiel or iliac fossa incision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the safety of low pressure versus standard pressure pneumoperitoneum in laparoscopic nephrectomy | Complications between two groups will determine the safety of procedure. | 30 days perioperative period | 
| To compare the efficacy of low pressure versus standard pressure pneumoperitoneum in laparoscopic nephrectomy | Operative time will help to determine efficacy of treatment. | 30 days perioperative period |