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

Primary Purpose

Renal Tumor

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
partial nephrectomy for complex renal tumor
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut Urology HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Open partial nephrectomy (Group A)

Robotic partial nephrectomy (group B)

Arm Description

patients in this group will have open partial nephrectomy for their renal tumors.

patients in this group will have robotic partial nephrectomy for their renal tumors.

Outcomes

Primary Outcome Measures

Successful excision of the tumor.
Achieving successful excision of the tumor in both open and robotic partial nephrectomy without any operative or immediate post-operative complications.

Secondary Outcome Measures

Status of recurrence free.
Patient is free from recurrent tumor in both study groups.

Full Information

First Posted
August 29, 2020
Last Updated
March 6, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04537247
Brief Title
A Comparative Study Between Open and Robotic Partial Nephrectomy in Treatment of High Complex Renal Tumors.
Official Title
A Comparative Study Between Open and Robotic Partial Nephrectomy in Treatment of High Complex Renal Tumors.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open partial nephrectomy (Group A)
Arm Type
Experimental
Arm Description
patients in this group will have open partial nephrectomy for their renal tumors.
Arm Title
Robotic partial nephrectomy (group B)
Arm Type
Experimental
Arm Description
patients in this group will have robotic partial nephrectomy for their renal tumors.
Intervention Type
Procedure
Intervention Name(s)
partial nephrectomy for complex renal tumor
Intervention Description
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).
Primary Outcome Measure Information:
Title
Successful excision of the tumor.
Description
Achieving successful excision of the tumor in both open and robotic partial nephrectomy without any operative or immediate post-operative complications.
Time Frame
two years
Secondary Outcome Measure Information:
Title
Status of recurrence free.
Description
Patient is free from recurrent tumor in both study groups.
Time Frame
two years follow up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Kamel, M.A urology
Phone
00201285569470
Ext
0020882143282
Email
ahmedalaa.uro@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Kamel, M.A urology
Organizational Affiliation
Faculty of Medicine, Assiut University, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut Urology Hospital
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vice Dean for Graduate Studies and Research Affairs A Vice Dean for Graduate Studies and Research Affairs, professor
Phone
0882333642
Ext
002
Email
med_vdgrad@aun.edu.eg

12. IPD Sharing Statement

Citations:
PubMed Identifier
28303428
Citation
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Results Reference
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PubMed Identifier
23130756
Citation
Alemozaffar M, Chang SL, Kacker R, Sun M, DeWolf WC, Wagner AA. Comparing costs of robotic, laparoscopic, and open partial nephrectomy. J Endourol. 2013 May;27(5):560-5. doi: 10.1089/end.2012.0462. Epub 2013 Jan 30.
Results Reference
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PubMed Identifier
25598603
Citation
Boylu U, Basatac C, Yildirim U, Onol FF, Gumus E. Comparison of surgical, functional, and oncological outcomes of open and robot-assisted partial nephrectomy. J Minim Access Surg. 2015 Jan-Mar;11(1):72-7. doi: 10.4103/0972-9941.147699.
Results Reference
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PubMed Identifier
24710511
Citation
Wu Z, Li M, Qu L, Ye H, Liu B, Yang Q, Sheng J, Xiao L, Lv C, Yang B, Gao X, Gao X, Xu C, Hou J, Sun Y, Wang L. A propensity-score matched comparison of perioperative and early renal functional outcomes of robotic versus open partial nephrectomy. PLoS One. 2014 Apr 7;9(4):e94195. doi: 10.1371/journal.pone.0094195. eCollection 2014.
Results Reference
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PubMed Identifier
23913095
Citation
Minervini A, Vittori G, Antonelli A, Celia A, Crivellaro S, Dente D, Di Santo V, Frea B, Gacci M, Gritti A, Masieri L, Morlacco A, Porreca A, Rocco B, Parma P, Simeone C, Zaramella S, Carini M, Serni S. Open versus robotic-assisted partial nephrectomy: a multicenter comparison study of perioperative results and complications. World J Urol. 2014 Feb;32(1):287-93. doi: 10.1007/s00345-013-1136-x. Epub 2013 Aug 4. Erratum In: World J Urol. 2014 Feb;32(1):295. multiple author names added.
Results Reference
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PubMed Identifier
27194142
Citation
Wang Y, Shao J, Ma X, Du Q, Gong H, Zhang X. Robotic and open partial nephrectomy for complex renal tumors: a matched-pair comparison with a long-term follow-up. World J Urol. 2017 Jan;35(1):73-80. doi: 10.1007/s00345-016-1849-8. Epub 2016 May 19.
Results Reference
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PubMed Identifier
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Citation
Kim JK, Lee H, Oh JJ, Lee S, Hong SK, Lee SE, Byun SS. Comparison of robotic and open partial nephrectomy for highly complex renal tumors (RENAL nephrometry score >/=10). PLoS One. 2019 Jan 10;14(1):e0210413. doi: 10.1371/journal.pone.0210413. eCollection 2019.
Results Reference
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A Comparative Study Between Open and Robotic Partial Nephrectomy in Treatment of High Complex Renal Tumors.

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