MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles

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

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.

Study Overview

• Status: Completed
• Conditions: Lymphocele After Surgical Procedure
• Intervention / Treatment: Other: Michl-stitch

• Study Type: Interventional
• Enrollment (Actual): 1080
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Martini-Klinik am UKE GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Experimental: Michl-stitch	Other: Michl-stitch; In the intervention group, a ventral fixation was performed by suturing the ventral bladder peritoneum to the plexus Santorini and from there to the right and left lateral endopelvic fascia (MICHL-stitch).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of lymphoceles requiring intervention after RARP	Clavien-Dindo >2°	one year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total lymphocele rate after RARP	Clavien-Dindo	one year follow-up
other complications ≥ grade IIIa according to Clavien-Dindo after RARP	Clavien-Dindo	one year follow-up
continence rates after RARP	EPIC	one year folow-up

Collaborators and Investigators

• Sponsor: Martini-Klinik am UKE GmbH
• Investigators: Principal Investigator: Uwe Michl, Martini-Klinik am UKE GmbH

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Actual): October 16, 2019
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: prostate cancer; lymphocele; radical prostatectomy; complication; pelvic lymph node dissection
• Additional Relevant MeSH Terms: Neoplasms; Lymphatic Diseases; Cysts; Lymphocele
• Other Study ID Numbers: 2017-PS-03; PV6099 (Other Identifier: Martini-Klinik)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A publication in a peer-reviewed journal is planned
• IPD Sharing Time Frame: after final analysis
• IPD Sharing Access Criteria: peer-reviewed journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No