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NCT06134700 Clinical Trial

Low Pressure Versus Standard Pressure Pneumoperitoneum in Laparoscopic Nephrectomy

Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06134700
Other study ID # MaharagjungMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 15, 2023
Est. completion date December 15, 2024

Study information
Verified date November 2023
Source Institute of medicine, Maharagjung medical campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 44
Est. completion date December 15, 2024
Est. primary completion date August 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients undergoing laparoscopic nephrectomy Exclusion Criteria: - Age <18 years - History of previous abdominal surgeries - Laparoscopic donor nephrectomies

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic Surgery
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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Institute of medicine, Maharagjung medical campus

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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