Lymphocele After Surgical Procedure
Conditions
Keywords
prostate cancer, radical prostatectomy, pelvic lymph node dissection, lymphocele, complication
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.
Interventions
OTHERMichl-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
Martini-Klinik am UKE GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of lymphoceles requiring intervention after RARP | one year follow-up | Clavien-Dindo \>2° |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total lymphocele rate after RARP | one year follow-up | Clavien-Dindo |
| other complications ≥ grade IIIa according to Clavien-Dindo after RARP | one year follow-up | Clavien-Dindo |
| continence rates after RARP | one year folow-up | EPIC |
Countries
Germany
Outcome results
None listed