Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphocele After Surgical Procedure | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Michl-stitch | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Michl-stitch
- interventionNames
- Other: Michl-stitch
- type
- NO_INTERVENTION
- label
- control
Primary outcomes (1)
- measure
- rate of lymphoceles requiring intervention after RARP
- timeFrame
- one year follow-up
- description
- Clavien-Dindo \>2°
Secondary outcomes (3)
- measure
- total lymphocele rate after RARP
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDPloussard 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. PMID 23582879
- BACKGROUNDKeskin 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. PMID 26800257
- BACKGROUNDWaldert 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. PMID 21542773
- BACKGROUNDYasumizu 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. PMID 23030822
- BACKGROUNDGrande 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. PMID 27544575
- BACKGROUNDLebeis 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. PMID 26099895