NCT06284135

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,080 (actual)
• Sponsor: Martini-Klinik am UKE GmbH · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2017-06-19
• Primary completion: 2019-10-16
• Completion: 2021-05-31
• First posted: 2024-02-28
• Last updated: 2024-02-28

Locations

1 site across 1 country: Germany