Clinical trial NCT06284135: MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles
Official title: Prospective Randomised Study to Examine the Influence of a Modification of the DaVinci Prostatectomy on the Frequency of Postoperative Lymphoceles Requiring Treatment and Postoperative Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphocele After Surgical Procedure
Keywords: prostate cancer
radical prostatectomy
pelvic lymph node dissection
lymphocele
complication
Lead sponsor: Martini-Klinik am UKE GmbH
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 1080
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A two-armed prospective randomised, controlled, single-centre trial on 1080 patients with prostate cancer who underwent robot-assisted radical prostatectomy with bilateral pelvic lymph node dissection was carried out. Patients in the intervention arm received fixation of the peritoneal flap of the bladder to the plexus Santorini at the end of surgery (Michl-technique, MT); in the control group, surgery was performed without this modification. The primary endpoint was the rate of lymphoceles requiring intervention.


Eligibility criteria: Inclusion Criteria:

* Declaration of consent signed
* Minimum age 18 years
* localised prostate carcinoma
* planned DVRP with bilateral lymphadenectomy

Exclusion Criteria:

* patient's lack of capacity to consent
* ORP
* no planned PLND
* metastatic prostate cancer
* ASA status \>3

Primary outcomes:
measure: rate of lymphoceles requiring intervention after RARP
timeFrame: one year follow-up
Secondary outcomes:
measure: total lymphocele rate after RARP
timeFrame: one year follow-up
measure: other complications ≥ grade IIIa according to Clavien-Dindo after RARP
timeFrame: one year follow-up
measure: continence rates after RARP
timeFrame: one year folow-up
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Martini-Klinik am UKE GmbH
Study officials:
affiliation: Martini-Klinik am UKE GmbH
name: Uwe Michl
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ploussard G, Briganti A, de la Taille A, Haese A, Heidenreich A, Menon M, Sulser T, Tewari AK, Eastham JA. Pelvic lymph node dissection during robot-assisted radical prostatectomy: efficacy, limitations, and complications-a systematic review of the literature. Eur Urol. 2014 Jan;65(1):7-16. doi: 10.1016/j.eururo.2013.03.057. Epub 2013 Apr 6.
citation: Keskin MS, Argun OB, Obek C, Tufek I, Tuna MB, Mourmouris P, Erdogan S, Kural AR. The incidence and sequela of lymphocele formation after robot-assisted extended pelvic lymph node dissection. BJU Int. 2016 Jul;118(1):127-31. doi: 10.1111/bju.13425. Epub 2016 Feb 17.
citation: Waldert M, Remzi M, Klatte T, Klingler HC. FloSeal reduces the incidence of lymphoceles after lymphadenectomies in laparoscopic and robot-assisted extraperitoneal radical prostatectomy. J Endourol. 2011 Jun;25(6):969-73. doi: 10.1089/end.2010.0635. Epub 2011 May 4.
citation: Yasumizu Y, Miyajima A, Maeda T, Takeda T, Hasegawa M, Kosaka T, Kikuchi E, Oya M. How can lymphocele development be prevented after laparoscopic radical prostatectomy? J Endourol. 2013 Apr;27(4):447-51. doi: 10.1089/end.2012.0356. Epub 2012 Dec 5.
citation: Grande P, Di Pierro GB, Mordasini L, Ferrari M, Wurnschimmel C, Danuser H, Mattei A. Prospective Randomized Trial Comparing Titanium Clips to Bipolar Coagulation in Sealing Lymphatic Vessels During Pelvic Lymph Node Dissection at the Time of Robot-assisted Radical Prostatectomy. Eur Urol. 2017 Feb;71(2):155-158. doi: 10.1016/j.eururo.2016.08.006. Epub 2016 Aug 17.
citation: Lebeis C, Canes D, Sorcini A, Moinzadeh A. Novel Technique Prevents Lymphoceles After Transperitoneal Robotic-assisted Pelvic Lymph Node Dissection: Peritoneal Flap Interposition. Urology. 2015 Jun;85(6):1505-9. doi: 10.1016/j.urology.2015.02.034.