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

NCT06284135 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1080

Last updated 2024-02-28

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Martini-Klinik am UKE GmbH

    lead OTHER

Principal Investigators

  • Uwe Michl · Martini-Klinik am UKE GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-19
Primary Completion
2019-10-16
Completion
2021-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06284135 on ClinicalTrials.gov