A Comparative Study Between Open and Robotic Partial Nephrectomy in Treatment of High Complex Renal Tumors.

March 6, 2022 updated by: Ahmed Alaa, Assiut University
To compare safety and efficacy between open and robotic partial nephrectomy in treatment of organ confined complex renal tumors (R.E.N.A.L score more than 7) as regarding surgical results, morbidity, clinical as well as oncological and functional outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Although radical nephrectomy was considered as the only effective treatment for malignant kidney tumors and maintained the prime solution for such tumors throughout the nineteenth century, partial nephrectomy became the preferred method in managing tumors of solitary kidneys, bilateral or hereditary renal tumors and in renal tumors of renal insufficiency patients. The shift to preserve sufficient as well as functioning renal volume, the improving experience with renal vasculature, proliferation of energy sources that achieved sufficient tissue cleavage and haemostatic power and refinements in hypothermia techniques helped the shift towards nephron sparing surgeries. Partial nephrectomy aimed at achieving complete removal of renal tumor with preservation of renal function, minimizing ischemia time as well as operative complications.

Open partial nephrectomy was the standard management strategy for organ-confined renal tumors in many centers worldwide. It is still the preferred method in most situations of complex tumors. Yet, open surgery has the inherent problem of poorly cosmetic scar, the need for analgesics, long hospital stay and wound related complications.

Laparoscopic partial nephrectomy (LPN) has largely replaced open partial nephrectomy worldwide as it combines the benefits of nephron sparing surgery (preserving the renal function) and laparoscopy (decreasing morbidity). The increasing experience of LPN enabled surgeons to operate not only small, peripheral, exophytic renal tumors, but also larger infiltrating tumors have been managed similarly. On the other hand, LPN still has technical difficulties that need steep learning curve to be mastered.

Robotic partial nephrectomy has become the surgery of choice not only for most renal tumors but also for benign kidney lesions. The minimally invasive nature of robotic surgery offers numerous advantages to the patient over open surgery including minimal tissue trauma, smaller scars, and faster recovery. Unlike laparoscopy, robotic surgeries grantee a three-dimensional view. The complex operative steps can be easily done due to the wider range of motion of the surgical instruments that the robot provides. Moreover, recent studies showed that robotic partial nephrectomy has shorter ischemia time, less blood loss and faster recovery than laparoscopy.

Despite the multiplicity of studies done for comparing between open and robotic partial nephrectomy in cases of small renal tumors, there are fewer studies comparing between open and robotic partial nephrectomy in management of complex renal tumors, which are not based on randomized bases.

Assiut University Hospitals are intending to be in a leading position in the field of minimal invasive surgery by constructing the first robotic surgery center in Upper Egypt. So, in our study, although robotic surgery seems to be more expensive, investigators suppose that robotic partial nephrectomy will yield better surgical and functional results than open partial nephrectomy in managing complex renal tumors. The promising technology will lead to decrease the robotic industry cost which, till now, remains the major drawback of robotic surgery worldwide spread. Another priority of our intended study is that it will alleviate any selection bias between the two techniques by being a prospective randomized one.

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Recruiting
        • Assiut Urology Hospital
        • Contact:
          • Vice Dean for Graduate Studies and Research Affairs A Vice Dean for Graduate Studies and Research Affairs, professor
          • Phone Number: 002 0882333642
          • Email: med_vdgrad@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any patient aged more than 18 years old with high complex renal tumor according to R.E.N.A.L scoring system (R.E.N.A.L score more than 7).

Exclusion Criteria:

  • 1- Renal tumors with R.E.N.A.L score less than 7, based on radio-logical findings.

    2- Renal tumors in congenitally anomalous kidney (horseshoe kidney, ectopic or malformed) or metastatic kidney disease.

    3- Gross lymphadenopathy (N1 According to TNM classification system of renal tumors) or suspicious vascular invasion (T3a, T3b or T3c according to TNM classification of renal tumors) (18).

    4- Renal pelvic tumor of upper urinary tract. 5- Patient refused to be enrolled in the study. 6- Defaulters of follow up. 7- Bleeding tendency. 8- Active peritoneal or bowel inflammatory process. 9- Clinically unfit patient.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open partial nephrectomy (Group A)
patients in this group will have open partial nephrectomy for their renal tumors.
Procedure: partial nephrectomy for complex renal tumor
removal of tumor with sufficient safety margin with preservation of functioning renal unit (renal tissue with its collecting system, arterial supply and venous as well as lymphatic drainage).
Experimental: Robotic partial nephrectomy (group B)
patients in this group will have robotic partial nephrectomy for their renal tumors.
Procedure: partial nephrectomy for complex renal tumor
removal of tumor with sufficient safety margin with preservation of functioning renal unit (renal tissue with its collecting system, arterial supply and venous as well as lymphatic drainage).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful excision of the tumor.
Time Frame: two years
Achieving successful excision of the tumor in both open and robotic partial nephrectomy without any operative or immediate post-operative complications.
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Status of recurrence free.
Time Frame: two years follow up.
Patient is free from recurrent tumor in both study groups.
two years follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Ahmed Kamel, M.A urology, Faculty of Medicine, Assiut University, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

August 29, 2020

First Submitted That Met QC Criteria

August 29, 2020

First Posted (Actual)

September 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 6, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • open versus robotic PN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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