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

NCT06284135 | Completed

• 2 other identifiers: 2017-PS-03PV6099
• Study Type: interventional
• Target: 1,080
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphocele After Surgical Procedure

Keywords

prostate cancer; radical prostatectomy; pelvic lymph node dissection; lymphocele; complication

Outcome Measures

Primary Outcomes (1)

• rate of lymphoceles requiring intervention after RARP

  Clavien-Dindo \>2°

  one year follow-up

Secondary Outcomes (3)

• total lymphocele rate after RARP

  one year follow-up

• other complications ≥ grade IIIa according to Clavien-Dindo after RARP

  one year follow-up

• continence rates after RARP

  one year folow-up

Study Arms (2)

Michl-stitch

EXPERIMENTAL

Other: Michl-stitch

control

NO INTERVENTION

Interventions

Michl-stitch OTHER

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).

Michl-stitch

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Martini-Klinik am UKE GmbH: lead

Study Sites (1)

Martini-Klinik am UKE GmbH

Hamburg, 20246, Germany

Location

Related Publications (6)

• 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.

  PMID: 23582879 BACKGROUND

• 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.

  PMID: 26800257 BACKGROUND

• 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.

  PMID: 21542773 BACKGROUND

• 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.

  PMID: 23030822 BACKGROUND

• 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.

  PMID: 27544575 BACKGROUND

• 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.

  PMID: 26099895 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Lymphocele

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Cysts; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Uwe Michl

  Martini-Klinik am UKE GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 28, 2024
• Study Start: June 19, 2017
• Primary Completion: October 16, 2019
• Study Completion: May 31, 2021
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after final analysis
• Access Criteria: peer-reviewed journal

Locations

DE (1)