Lymphocele After Surgical ProcedureNCT06284135
MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles
A study testing Michl-stitch in people with Lymphocele After Surgical Procedure, run by Martini-Klinik am UKE GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Lymphocele After Surgical Procedure
- What is being tested?
- Michl-stitch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 1 siteGermany
- Study dates
- 19 Jun 2017to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Declaration of consent signed
- Minimum age 18 years
- localised prostate carcinoma
- planned DVRP with bilateral lymphadenectomy
Who cannot join
- patient's lack of capacity to consent
- ORP
- no planned PLND
- metastatic prostate cancer
- ASA status >3
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Michl-stitch
- Keywords
- prostate cancer, radical prostatectomy, pelvic lymph node dissection, lymphocele, complication
- Medical subject headings
- Prostatic Neoplasms, Lymphocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Michl-stitchOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Michl-stitch | Experimental | Not described Receives: Other: Michl-stitch |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of lymphoceles requiring intervention after RARP
Clavien-Dindo >2°
Measured: one year follow-up
Secondary outcomes (3)
total lymphocele rate after RARP
Clavien-Dindo
Measured: one year follow-up
other complications ≥ grade IIIa according to Clavien-Dindo after RARP
Clavien-Dindo
Measured: one year follow-up
continence rates after RARP
EPIC
Measured: one year folow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start19 Jun 2017
- Primary completion16 Oct 2019
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lymphocele After Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martini-Klinik am UKE GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uwe Michl, Principal investigator, Martini-Klinik am UKE GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284135
- Sponsor's protocol ID
- 2017-PS-03
- Other IDs
- PV6099
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A publication in a peer-reviewed journal is planned
Publications
Ploussard 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.
PubMed 23582879Keskin 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.
PubMed 26800257Waldert 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.
PubMed 21542773Yasumizu 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.
PubMed 23030822Grande 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.
PubMed 27544575Lebeis 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.
PubMed 26099895
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06284135
- Acronym / sponsor ID
- 2017-PS-03
- Conditions
- Lymphocele After Surgical Procedure
- Keywords
- prostate cancer, radical prostatectomy, pelvic lymph node dissection, lymphocele, complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- Martini-Klinik am UKE GmbHUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Michl-stitch | Experimental | Other: Michl-stitch |
| control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Declaration of consent signed
- Minimum age 18 years
- localised prostate carcinoma
- planned DVRP with bilateral lymphadenectomy
Key exclusion criteria (5 listed)
- patient's lack of capacity to consent
- ORP
- no planned PLND
- metastatic prostate cancer
- ASA status >3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Michl-stitchIn 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). | Other | Michl-stitch |
Primary outcome
rate of lymphoceles requiring intervention after RARP
Time frame: one year follow-up
Clavien-Dindo >2°
3 secondary outcomes
total lymphocele rate after RARP
Time frame: one year follow-up
other complications ≥ grade IIIa according to Clavien-Dindo after RARP
Time frame: one year follow-up
continence rates after RARP
Time frame: one year folow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 23582879Ploussard 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.
- Background: PubMed 26800257Keskin 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.
- Background: PubMed 21542773Waldert 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.
- Background: PubMed 23030822Yasumizu 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.
- Background: PubMed 27544575Grande 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.
- Background: PubMed 26099895Lebeis 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.
- Individual participant dataSharing planned: Yes. A publication in a peer-reviewed journal is planned
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwe Michl principal investigator
Martini-Klinik am UKE GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Michl-stitch in people with Lymphocele After Surgical Procedure, run by Martini-Klinik am UKE GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of lymphoceles requiring intervention after RARP (time frame: one year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06284135, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.