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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Pneumoperitoneum
• Renal Cell Carcinoma

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