Nonfunctioning Kidney, Renal Cell Carcinoma (RCC)
Conditions
Keywords
Clinical effectiveness of laparoscopic nephrectomy, Cost analysis of laparoscopic nephrectomy
Brief summary
To evaluate and compare clinical effectiveness (operative time, blood loss, hospital stay, complications and etc) and cost analysis' between laparoscopic nephrectomy and open nephrectomy .
Interventions
PROCEDUREopen or laparoscopic nephrectomy
compare post operative recovery , estimated blood loss and cost analysis between open and laparosopic nephrectomy.
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
To evaluate and compare clinical effectiveness (operative time, blood loss, hospital stay, complications and etc) and cost analysis between laparoscopic nephrectomy and open nephrectomy . randomized, controlled parallel-group clinical trials comparing peri-operative (pre-, intra-, and postoperative) assessments and cost outcomes of laparoscopic nephrectomy versus open nephrectomy.
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* American Society of Anesthesiology score 1-3. * Indication for : * 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. * Patient deemed fit for general anesthesia and surgery. * Patient provides written informed consent.
Exclusion criteria
* 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. * Need for concomitant major procedures (eg, large bowel resection) at index operation. * Locally advanced tumor with obvious major vascular involvement requiring complex vascular reconstruction. * Uncorrected coagulopathy. * Pregnancy or Obese patient (BMI \> 40) * Inability to provide informed consent or comply with follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay (LOS). | 30 days post operative | Number of calendar days from date of index surgery to date of discharge . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical effectiveness | Post operative 30 days. | 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. |
Countries
Egypt
Contacts
CONTACTHaitham Badr Elnaggar
Outcome results
None listed