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

NCT04537247 | Completed

• 1 other identifier: open versus robotic PN
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Tumor

Outcome Measures

Primary Outcomes (1)

• 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.

  two years

Secondary Outcomes (1)

• Status of recurrence free.

  two years follow up.

Study Arms (2)

Open partial nephrectomy (Group A)

EXPERIMENTAL

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

Procedure: partial nephrectomy for complex renal tumor

Robotic partial nephrectomy (group B)

EXPERIMENTAL

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

Procedure: partial nephrectomy for complex renal tumor

Interventions

partial nephrectomy for complex renal tumor PROCEDURE

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).

Open partial nephrectomy (Group A); Robotic partial nephrectomy (group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Renal tumors with R.E.N.A.L score less than 7, based on radio-logical findings.
• Renal tumors in congenitally anomalous kidney (horseshoe kidney, ectopic or malformed) or metastatic kidney disease.
• 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).
• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Urology Hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (7)

• Pavan N, Derweesh IH, Mir CM, Novara G, Hampton LJ, Ferro M, Perdona S, Parekh DJ, Porpiglia F, Autorino R. Outcomes of Laparoscopic and Robotic Partial Nephrectomy for Large (>4 Cm) Kidney Tumors: Systematic Review and Meta-Analysis. Ann Surg Oncol. 2017 Aug;24(8):2420-2428. doi: 10.1245/s10434-017-5831-5. Epub 2017 Mar 16.

  PMID: 28303428 BACKGROUND

• 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.

  PMID: 23130756 BACKGROUND

• 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.

  PMID: 25598603 BACKGROUND

• 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.

  PMID: 24710511 BACKGROUND

• 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.

  PMID: 23913095 BACKGROUND

• 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.

  PMID: 27194142 BACKGROUND

• 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.

  PMID: 30629644 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Ahmed Kamel, M.A urology

  Faculty of Medicine, Assiut University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Urology surgery.

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 3, 2020
• Study Start: April 1, 2021
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)