Low Pressure Versus Standard Pressure Pneumoperitoneum in Laparoscopic Nephrectomy

November 11, 2023 updated by: Anjit Phuyal, Institute of medicine, Maharagjung medical campus

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients undergoing laparoscopic nephrectomy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low pressure pneumoperitoneum laparoscopic nephrectomy
Pneumoperitonuem Pressure of 8 - 10 mmHg
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
Active Comparator: Standard pressure pneumoperitoneum laparoscopic nephrectomy
Pneumoperitonuem Pressure of 12 - 15 mmHg
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the safety of low pressure versus standard pressure pneumoperitoneum in laparoscopic nephrectomy
Time Frame: 30 days perioperative period
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
Time Frame: 30 days perioperative period
Operative time will help to determine efficacy of treatment.
30 days perioperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of medicine, Maharagjung medical campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 15, 2023

Primary Completion (Estimated)

August 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

October 14, 2023

First Submitted That Met QC Criteria

November 11, 2023

First Posted (Estimated)

November 16, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 11, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MaharagjungMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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