- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07461090
Laparoscopic Versus Open Nephrectomy : Clinical Effectivness and Cost Analysis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Haitham Badr Elnaggar
- Phone Number: 002 01003247485
- Email: naggarheso@gmail.com
Study Locations
-
-
Shebin Elkom
-
Shibīn al Kawm, Shebin Elkom, Egypt, 32111
- Recruiting
- Menoufia Faculty of Medicine
-
Contact:
- Mohamed Ibrahim Abozaid
- Phone Number: +20 10 68588750
- Email: Mabozaid84@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: open nephrectomy
Length of hospital stay (LOS) , post operative rehabilitation and cost analysis
|
compare post operative recovery , estimated blood loss and cost analysis between open and laparosopic nephrectomy.
|
|
Active Comparator: laparoscopic nephrectomy
Length of hospital stay (LOS) , post operative rehabilitation and cost analysis
|
compare post operative recovery , estimated blood loss and cost analysis between open and laparosopic nephrectomy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of hospital stay (LOS).
Time Frame: 30 days post operative
|
Number of calendar days from date of index surgery to date of discharge .
|
30 days post operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clinical effectiveness
Time Frame: 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. |
Post operative 30 days.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Urologic Neoplasms
- Carcinoma
- Kidney Neoplasms
- Carcinoma, Renal Cell
Other Study ID Numbers
- laparoscopic nephrectomy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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