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Low Pressure Versus Standard Pressure Pneumoperitoneum in Laparoscopic Nephrectomy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06134700
Enrollment
44
Registered
2023-11-18
Start date
2023-11-15
Completion date
2024-12-15
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Functioning Kidney, Renal Cell Carcinoma

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

Interventions

PROCEDURELaparoscopic 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

Sponsors

Institute of medicine, Maharagjung medical campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

Participants will be blinded.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients undergoing laparoscopic nephrectomy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
To compare the safety of low pressure versus standard pressure pneumoperitoneum in laparoscopic nephrectomy30 days perioperative periodComplications between two groups will determine the safety of procedure.
To compare the efficacy of low pressure versus standard pressure pneumoperitoneum in laparoscopic nephrectomy30 days perioperative periodOperative time will help to determine efficacy of treatment.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026