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Clinical Trials/NCT06134700
NCT06134700Not yet recruitingNot Applicable

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

Institute of medicine, Maharagjung medical campus0 sites44 target enrollmentStarted: November 15, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
44
Primary Endpoint
To compare the safety of low pressure versus standard pressure pneumoperitoneum in laparoscopic nephrectomy

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Masking Description

Participants will be blinded.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All patients undergoing laparoscopic nephrectomy

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Institute of medicine, Maharagjung medical campus
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anjit Phuyal

Dr

Institute of medicine, Maharagjung medical campus

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