Laparoscopic Versus Open Nephrectomy : Clinical Effectivness and Cost Analysis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1+
SponsorMenoufia University
About this trial
To evaluate and compare clinical effectiveness (operative time, blood loss, hospital stay, complications and etc) and cost analysis' between laparoscopic nephrectomy and open nephrectomy .
Eligibility criteria
This trial accepts healthy volunteersQualifiers
American Society of Anesthesiology score 1-3.
Simple total nephrectomy or hemi nephrectomy: benign chronic inflammatory non-functioning kidney
Partial nephrectomy: localized renal mass ≤7 cm suitable for nephron-sparing surgery.
Radical nephrectomy or Radical nephrouretrectomy with bladder cuff: localized renal tumor requiring complete nephrectomy without major vascular invasion.
Disqualifiers
emergency surgery, dialysis-dependent patients, planned hybrid procedures.
Patients with incomplete data
Patients with metastatic disease at presentation.
Prior extensive ipsilateral retroperitoneal surgery or severe adhesions precluding Laparoscopy.
Trial design
Design model
Parallel
Treatments tested in this trial
open or laparoscopic nephrectomy
Procedure/Surgerycompare post operative recovery , estimated blood loss and cost analysis between open and laparosopic nephrectomy.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: open nephrectomyActive comparator 1 intervention
Group B: laparoscopic nephrectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Length of hospital stay (LOS).
Number of calendar days from date of index surgery to date of discharge .
Time frame
30 days post operativeSecondary outcomes
1
clinical effectiveness
Functional recovery was evaluated using a modified World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). The questionnaire consists of 10 items scored on a 5-point scale (0-4), with a total score ranging from 0 to 40, where higher scores indicate worse functional outcome and greater disability while Lower scores indicate better functional recovery.
Time frame
Post operative 30 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov