Low Pressure Versus Standard Pressure Pneumoperitoneum in Laparoscopic Nephrectomy

Trial Title: Low Pressure Versus Standard Pressure Pneumoperitoneum in Laparoscopic Nephrectomy

NCT ID: NCT06134700

Condition: Non-Functioning Kidney
Renal Cell Carcinoma

Conditions: Official terms:
Carcinoma, Renal Cell
Pneumoperitoneum

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: Single (Participant)

Masking description: Participants will be blinded.

Intervention:

Intervention type: Procedure
Intervention name: Laparoscopic Surgery
Description: - 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
Arm group label: Low pressure pneumoperitoneum laparoscopic nephrectomy
Arm group label: Standard pressure pneumoperitoneum laparoscopic nephrectomy

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

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: November 15, 2023

Completion date: December 15, 2024

Lead sponsor:
Agency: Institute of medicine, Maharagjung medical campus
Agency class: Other

Source: Institute of medicine, Maharagjung medical campus

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06134700