Low Pressure Versus Standard Pressure Pneumoperitoneum in Laparoscopic Nephrectomy

Not Applicable

Not yet recruiting

• Conditions: Renal Cell Carcinoma; Non-Functioning Kidney
• Interventions: Procedure: Laparoscopic Surgery

• Registration Number: NCT06134700
• Lead Sponsor: Institute of medicine, Maharagjung medical campus

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-14
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-11
• Last Update Submitted: 2023-11-11
• Study Start: 2023-11-15
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-08-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• All patients undergoing laparoscopic nephrectomy

Exclusion Criteria

• Age <18 years
• History of previous abdominal surgeries
• Laparoscopic donor nephrectomies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low pressure pneumoperitoneum laparoscopic nephrectomy	Laparoscopic Surgery	Pneumoperitonuem Pressure of 8 - 10 mmHg
Standard pressure pneumoperitoneum laparoscopic nephrectomy	Laparoscopic Surgery	Pneumoperitonuem Pressure of 12 - 15 mmHg

Primary Outcome Measures

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