Low Pressure Versus Standard Pressure Pneumoperitoneum in Laparoscopic Nephrectomy

NCT06134700 | Unknown DMC

• 1 other identifier: MaharagjungMC
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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

Conditions

Non-Functioning Kidney; Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Low pressure pneumoperitoneum laparoscopic nephrectomy

EXPERIMENTAL

Pneumoperitonuem Pressure of 8 - 10 mmHg

Procedure: Laparoscopic Surgery

Standard pressure pneumoperitoneum laparoscopic nephrectomy

ACTIVE COMPARATOR

Pneumoperitonuem Pressure of 12 - 15 mmHg

Procedure: Laparoscopic Surgery

Interventions

Laparoscopic Surgery PROCEDURE

* 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

Low pressure pneumoperitoneum laparoscopic nephrectomy; Standard pressure pneumoperitoneum laparoscopic nephrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing laparoscopic nephrectomy

You may not qualify if:

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

Sponsors & Collaborators

• Institute of medicine, Maharagjung medical campus: lead

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 14, 2023
• First Posted: November 18, 2023
• Study Start: November 15, 2023
• Primary Completion: August 15, 2024
• Study Completion: December 15, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share