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

Lymphocele After Surgical Procedure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06284135
• Other study ID #: 2017-PS-03
• Secondary ID: PV6099
• Status: Completed
• Phase: N/A
• Start date: June 19, 2017
• Est. completion date: May 31, 2021

Study information

• Verified date: February 2024
• Source: Martini-Klinik am UKE GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1080
• Est. completion date: May 31, 2021
• Est. primary completion date: October 16, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphocele
• Lymphocele After Surgical Procedure

Intervention

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).

Locations

Country	Name	City	State
Germany	Martini-Klinik am UKE GmbH	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Martini-Klinik am UKE GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of lymphoceles requiring intervention after RARP	Clavien-Dindo >2°	one year follow-up
Secondary	total lymphocele rate after RARP	Clavien-Dindo	one year follow-up
Secondary	other complications = grade IIIa according to Clavien-Dindo after RARP	Clavien-Dindo	one year follow-up
Secondary	continence rates after RARP	EPIC	one year folow-up