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OpenTrials
Completed

NCT Number: NCT06284135

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

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.

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Key information

Conditions

Lymphocele After Surgical Procedure Cysts Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hemic and Lymphatic Diseases Lymphatic Diseases Lymphocele Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Martini-Klinik am UKE GmbH

Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. rate of lymphoceles requiring intervention after RARP

    Time frame: one year follow-up

    Clavien-Dindo >2°

Secondary outcomes

  1. total lymphocele rate after RARP

    Time frame: one year follow-up

    Clavien-Dindo

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

    Time frame: one year follow-up

    Clavien-Dindo

  3. continence rates after RARP

    Time frame: one year folow-up

    EPIC

Sponsors and collaborators

Lead sponsor

Martini-Klinik am UKE GmbH

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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