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Low Pressure Versus Standard Pressure Pneumoperitoneum in Laparoscopic Nephrectomy

Sponsor
Institute of medicine, Maharagjung medical campus (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06134700
Collaborator
(none)
44
Enrollment
2
Arms
13
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopic Surgery
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Participants will be blinded.
Primary Purpose:
Other
Official Title:
Low Pressure Versus Standard Pressure Pneumoperitoneum in Laparoscopic Nephrectomy: A Prospective Randomised Controlled Trial
Anticipated Study Start Date :
Nov 15, 2023
Anticipated Primary Completion Date :
Aug 15, 2024
Anticipated Study Completion Date :
Dec 15, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. To compare the safety of low pressure versus standard pressure pneumoperitoneum in laparoscopic nephrectomy [30 days perioperative period]

    Complications between two groups will determine the safety of procedure.

  2. To compare the efficacy of low pressure versus standard pressure pneumoperitoneum in laparoscopic nephrectomy [30 days perioperative period]

    Operative time will help to determine efficacy of treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Institute of medicine, Maharagjung medical campus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anjit Phuyal, Dr, Institute of medicine, Maharagjung medical campus
ClinicalTrials.gov Identifier:
NCT06134700
Other Study ID Numbers:
  • MaharagjungMC
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma, Renal Cell
Pneumoperitoneum

Study Results

No Results Posted as of Nov 18, 2023