Comparison of the Application of Robot-assisted Laparoscopic Pathways in Radical Cystectomy

NCT ID: NCT06253091

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-12-30

Brief Summary

Traditional radical cystectomy (RC) is performed transabdominal. However, it often has high postoperative complications. There have been studies on extraperitoneal approach to reduce postoperative complications. Investigators divided participants underwent robot-assisted radical cystectomy into two groups (1:1) . One group of participants transabdominal, the other group extraperitoneal. The incidence of complications and PFS/OS at 3, and 5 years were compared.

Detailed Description

Bladder cancer is highly prevalent worldwide and approximately 75% of these are non-muscle invasive bladder cancer (NMIBC). For high-risk NMIBC and MIBC, radical cystectomy (RC) is also the best treatment option.

The traditional transperitoneal laparoscopic radical cystectomy prolapse of abdominal organs into the pelvic cavity can lead to angulation of the intestinal tract, causing obstruction. Some studies have demonstrated that the extraperitoneal route can effectively reduce these complications Currently, robot-assisted surgery technology is widely utilized in urology. Studies have demonstrated that robot-assisted total extraperitoneal cystectomy and urinary diversion are less likely to disrupt abdominal organs, particularly the intestines. Identifying and locating membrane structures and layers with anatomical significance is crucial for navigating the correct anatomic space during the operation. The using of 3D laparoscopy or a robot-assisted extraperitoneal radical cystectomy aligns more closely with the 3D membrane anatomic concept. Furthermore, for younger patients,robot-assisted extraperitoneal radical cystectomy is more favorable for preserving reproductive function. For elderly patients, it is considered more safer.

Consequently, we aim to investigate whether robot-assisted extraperitoneal radical cystectomy is more advantageous for patients with MIBC or high-risk NMIBC.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

robit-assist transperitoneal laparoscopic radical cystectomy

robit-assist radical cystectomy was performed transperitoneal

Group Type: NO_INTERVENTION

No interventions assigned to this group

robit-assist extraperitoneal laparoscopic radical cystectomy

robit-assist radical cystectomy was performed extraperitoneal

Group Type: EXPERIMENTAL

robit-assist extraperitoneal laparoscopic radical cystectomy

Intervention Type: PROCEDURE

robit-assist laparoscopic radical cystectomy was performed extraperitoneal

Interventions

robit-assist extraperitoneal laparoscopic radical cystectomy

robit-assist laparoscopic radical cystectomy was performed extraperitoneal

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Researchers evaluated patients with muscle invasive bladder cancer or high-risk non-muscular invasive bladder cancer who needed radical cystectomy.

2. Willing to accept the operation and meet the surgical index: a) Absolute count of neutrophils≥1.5x109/L; b) Platelets≥100×109/L; c) Hemoglobin≥90g/L; d) International standardized ratio or activationPartial thrombin time≤1.5 Upper limit of normal value (ULN); e) calculated creatinine clearance rate≥1 ml/s; f) Total serum bilirubin≤1.5×ULN; g) AST, ALT and alkaline phosphatase≤2.5×ULN; h) Cardiopulmonary function indicates that it can tolerate major abdominal surgery;

3. None of the pastHistory of abdominal surgery;

4. 18 to 75 years old;

5. ECOG physical state 0 or 1;

6. voluntarily participate in this experiment, be able to provide a written version of the informed consent, and be able to understand and agree to comply with the requirements of this study and the evaluation schedule;

Exclusion Criteria

1. Patients who refuse to receive radical cystectomy

2. Researchers evaluate patients who are unable to tolerate radical cystectomy;

3. There is a abdominal history of surgery;

4. Have had a large-scale operation or major trauma within 28 days before joining the group;

5. Have been vaccinated with live vaccine within 28 days before joining the group;

6. Severe chronic or active infection that requires systemic anti-bacterial, antifungal or antiviral treatment within 14 days before joining the group;

7. Participating in the rest of the clinical research.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lv qiang, PhD

Role: STUDY_CHAIR

The First Affiliated Hospital with Nanjing Medical University

Locations

The first affiliated hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yang Xiao Yang, MD

Role: CONTACT

yangxiao2915@163.com

+86 13951813528

bai rongjie

Role: CONTACT

bai_rongjie@163.com

+86 15151211913

Facility Contacts

Qiang Lu, PhD

Role: primary

dxhlvqiang@163.com

13505196501

Pengchao Li, PhD

Role: backup

superkulian@aliyun.com

13584025756

References

Lobo N, Afferi L, Moschini M, Mostafid H, Porten S, Psutka SP, Gupta S, Smith AB, Williams SB, Lotan Y. Epidemiology, Screening, and Prevention of Bladder Cancer. Eur Urol Oncol. 2022 Dec;5(6):628-639. doi: 10.1016/j.euo.2022.10.003. Epub 2022 Nov 1.

Reference Type: BACKGROUND

PMID: 36333236 (View on PubMed)

Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

Reference Type: BACKGROUND

PMID: 33538338 (View on PubMed)

Knowles MA, Hurst CD. Molecular biology of bladder cancer: new insights into pathogenesis and clinical diversity. Nat Rev Cancer. 2015 Jan;15(1):25-41. doi: 10.1038/nrc3817.

Reference Type: BACKGROUND

PMID: 25533674 (View on PubMed)

Witjes JA, Bruins HM, Cathomas R, Comperat EM, Cowan NC, Gakis G, Hernandez V, Linares Espinos E, Lorch A, Neuzillet Y, Rouanne M, Thalmann GN, Veskimae E, Ribal MJ, van der Heijden AG. European Association of Urology Guidelines on Muscle-invasive and Metastatic Bladder Cancer: Summary of the 2020 Guidelines. Eur Urol. 2021 Jan;79(1):82-104. doi: 10.1016/j.eururo.2020.03.055. Epub 2020 Apr 29.

Reference Type: BACKGROUND

PMID: 32360052 (View on PubMed)

Haeuser L, Marchese M, Noldus J, Kibel AS, Carvalho F, Preston MA, Cooper Z, Trinh QD, Mossanen M. Association between Operative Time and Short-Term Radical Cystectomy Complications. Urol Int. 2023;107(3):273-279. doi: 10.1159/000522141. Epub 2022 Mar 18.

Reference Type: BACKGROUND

PMID: 35306500 (View on PubMed)

Parra RO, Andrus CH, Jones JP, Boullier JA. Laparoscopic cystectomy: initial report on a new treatment for the retained bladder. J Urol. 1992 Oct;148(4):1140-4. doi: 10.1016/s0022-5347(17)36843-x.

Reference Type: BACKGROUND

PMID: 1404624 (View on PubMed)

Cao Q, Li P, Yang X, Qian J, Wang Z, Lu Q, Gu M. Laparoscopic radical cystectomy with pelvic re-peritonealization: the technique and initial clinical outcomes. BMC Urol. 2018 Dec 12;18(1):113. doi: 10.1186/s12894-018-0424-6.

Reference Type: BACKGROUND

PMID: 30541538 (View on PubMed)

Kulkarni JN, Gulla RI, Tongaonkar HB, Kashyapi BD, Rajyaguru KB. Radical cystoprostatectomy: an extraperitoneal retrograde approach. J Urol. 1999 Feb;161(2):545-8. doi: 10.1016/s0022-5347(01)61946-3.

Reference Type: BACKGROUND

PMID: 9915445 (View on PubMed)

Zhu YP, Ye DW, Yao XD, Zhang SL, Dai B, Shen YJ, Wang CF. Defining good candidates for extraperitoneal cystectomy: results from random peritoneum biopsies of 136 cases. Urology. 2013 Apr;81(4):820-4. doi: 10.1016/j.urology.2012.11.057. Epub 2013 Feb 20.

Reference Type: BACKGROUND

PMID: 23434097 (View on PubMed)

Park DS, Gong IH, Choi DK, Hwang JH, Kang MH, Oh JJ. A feasibility study of peritoneum preservation in radical cystectomy with extraperitonealization of orthotopic neobladder for invasive high-grade bladder cancer: a preliminary analysis. Int Urol Nephrol. 2014 Jun;46(6):1107-13. doi: 10.1007/s11255-013-0632-7. Epub 2013 Dec 20.

Reference Type: BACKGROUND

PMID: 24356919 (View on PubMed)

De Nunzio C, Cicione A, Leonardo F, Rondoni M, Franco G, Cantiani A, Tubaro A, Leonardo C. Extraperitoneal radical cystectomy and ureterocutaneostomy in octogenarians. Int Urol Nephrol. 2011 Sep;43(3):663-7. doi: 10.1007/s11255-010-9876-7. Epub 2010 Nov 26.

Reference Type: BACKGROUND

PMID: 21110093 (View on PubMed)

Jentzmik F, Schostak M, Stephan C, Baumunk D, Lingnau A, Weikert S, Lein M, Miller K, Schrader M. Extraperitoneal radical cystectomy with extraperitonealization of the ileal neobladder: a comparison to the transperitoneal technique. World J Urol. 2010 Aug;28(4):457-63. doi: 10.1007/s00345-009-0476-z. Epub 2009 Sep 24.

Reference Type: BACKGROUND

PMID: 19777243 (View on PubMed)

Feng L, Song J, Wu M, Tian Y, Zhang D. Extraperitoneal versus transperitoneal laparoscopic radical cystectomy for selected elderly bladder cancer patients: a single center experience. Int Braz J Urol. 2016 Jul-Aug;42(4):655-62. doi: 10.1590/S1677-5538.IBJU.2015.0608.

Reference Type: BACKGROUND

PMID: 27564274 (View on PubMed)

Refaai K, Sharafeldin MA, Elabbady A, Sameh W, Thurairaja R, Nair R, Dasgupta P, Khan MS, Mohamed E. Perioperative Outcomes of Open Retrograde Extraperitoneal Versus Intracorporeal Robot-assisted Radical Cystoprostatectomy in Men: A Dual-center Comparative Study. Clin Genitourin Cancer. 2020 Jun;18(3):e315-e323. doi: 10.1016/j.clgc.2019.12.006. Epub 2019 Dec 14.

Reference Type: BACKGROUND

PMID: 31911120 (View on PubMed)

Kulkarni JN, Agarwal H. Transperitoneal vs. extraperitoneal radical cystectomy for bladder cancer: A retrospective study. Int Braz J Urol. 2018 Mar-Apr;44(2):296-303. doi: 10.1590/S1677-5538.IBJU.2017.0441.

Reference Type: BACKGROUND

PMID: 29219280 (View on PubMed)

Zhao J, Zeng S, Zhang Z, Zhou T, Yang B, Song R, Sun Y, Xu C. Laparoscopic Radical Cystectomy Versus Extraperitoneal Radical Cystectomy: Is the Extraperitoneal Technique Rewarding? Clin Genitourin Cancer. 2015 Aug;13(4):e271-e277. doi: 10.1016/j.clgc.2015.01.006. Epub 2015 Jan 21.

Reference Type: BACKGROUND

PMID: 25743207 (View on PubMed)

Zhu G, Zhang Z, Zhao K, Yin X, Zhang Y, Wang Z, Li C, Sui Y, Li X, Yang H, Xing N, Wang K. Laparoscopic radical cystectomy with pelvic lymph node dissection and ileal orthotopic neobladder by a total extraperitoneal approach: Our initial technique and short-term outcomes. Investig Clin Urol. 2022 Sep;63(5):523-530. doi: 10.4111/icu.20220156.

Reference Type: BACKGROUND

PMID: 36067997 (View on PubMed)

Soleimani M, Moradkhani E, Masoumi N, Gholivandan J. Extra-Peritoneal versus Trans-Peritoneal Open Radical Cystectomy - Comparison of Two Techniques in Early Post-Operative Complications. Urol J. 2021 Nov 7;18(5):519-524. doi: 10.22037/uj.v16i7.6147.

Reference Type: BACKGROUND

PMID: 32827149 (View on PubMed)

Yang H, Zhang Z, Zhao K, Zhang Y, Yin X, Zhu G, Lin C, Liu C, Wang Z, Sui Y, Li X, Li C, Wang K. Extraperitoneal Laparoscopic Radical Cystectomy With Preservation of Fertility for the Treatment of Ewing Sarcoma: The First Report of a Reliable Surgical Method. Urology. 2022 Jan;159:241-246. doi: 10.1016/j.urology.2021.09.024. Epub 2021 Oct 13.

Reference Type: BACKGROUND

PMID: 34653432 (View on PubMed)

Malinaric R, Mantica G, Balzarini F, Terrone C, Maffezzini M. Extraperitoneal cystectomy with ureterocutaneostomy derivation in fragile patients - should it be performed more often? Arch Ital Urol Androl. 2022 Jun 29;94(2):144-149. doi: 10.4081/aiua.2022.2.144.

Reference Type: BACKGROUND

PMID: 35775336 (View on PubMed)

Li Z, Zhang Z, Ma H, Yao K, Qin Z, Han H, Ye Y, Li Y, Dong P, Jiang L, Tian L, Liu Z, Zhou F. Extraperitonealization of ileal conduit reduces parastomal hernia after cystectomy and ileal conduit diversion. Urol Oncol. 2022 Apr;40(4):162.e17-162.e23. doi: 10.1016/j.urolonc.2021.11.022. Epub 2021 Dec 15.

Reference Type: BACKGROUND

PMID: 34920945 (View on PubMed)

Kulkarni JN, Rizvi SJ, Acharya UP, Kumar KS, Tiwari P. Gynecologic-tract sparing extra peritoneal retrograde radical cystectomy with neobladder. Int Braz J Urol. 2008 Mar-Apr;34(2):180-7; discussion 187-90. doi: 10.1590/s1677-55382008000200008.

Reference Type: BACKGROUND

PMID: 18462516 (View on PubMed)

Other Identifiers

2023-SR-017

Identifier Type: -

Identifier Source: org_study_id