Peripheral Nerve InjuriesNCT02437695
Robot Assisted Radical Prostatecomy and Positional Injury
An observational study of Peripheral Nerve Injuries, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Although a condition for surgery, robotic interventions applied with steep Trendelenburg-lithotomy (ST-L) position may cause positional injury and peripheral neuropathy if good position is not achieved on the operating table. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Peripheral Nerve Injuries
- How many people
- 450 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2015to Jul 2015
- Phase
- Observational
- 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 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing robot-assisted radical prostatectomy (RARP) for prostate diagnosis.
Who may be able to join
- Patients undergoing robot-assisted radical prostatectomy (RARP) for prostate diagnosis.
Who cannot join
- Patients with known peripheral neuropathy,
- Lumbar-cervical discopathy,
- History of orthopaedic surgery or
- Trauma were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robot Assisted Radical Prostatecomy and Positional Injury; 8 Years Survey
Although a condition for surgery, robotic interventions applied with steep Trendelenburg-lithotomy (ST-L) position may cause positional injury and peripheral neuropathy if good position is not achieved on the operating table. This study will be a 7-year retrospective examination of postoperative positional injury (PPI) in patients undergoing robot-assisted radical prostatectomy (RARP) for prostate diagnosis.
Read the detailed description
Patients who underwent RARP between 2008-2014 will be evaluate. Patients with known peripheral neuropathy, lumbar-cervical discopathy, or history of orthopaedic surgery or trauma will exclude. The demographic data of patients, ASA, Charlson Comorbidity Index (CMI), Body Mass Index (BMI), operating time (OT) and Trendelenburg time (TT) will obtain from patient records. Patients will be questioned as to whether or not PPI had developed, if so, in which extremity, in what form (sensory-motor), duration, whether or not a doctor had been consulted, if so, what treatment had been given and whether or not the PPI had continued.
- Conditions
- Peripheral Nerve Injuries
- Keywords
- Robotic Surgical Procedures, Trendelenburg Position
- Medical subject headings
- Peripheral Nerve Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
retrospective examination of postoperative positional injury (PPI) in patients undergoing robot-assisted radical prostatectomy (RARP) for prostate diagnosis
The ST-L position carries high risk in terms of PPI, especially when lengthy surgery is planned and the risk could be increased in patients with high BMI.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Nerve InjuriesStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gulsah Karaoren, Umraniye Education and Research Hospital
- Investigators
- Nurten Bakan, MD, Study chair, Unraniye training and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437695
- Sponsor's protocol ID
- GK3
- Status last verified
- Dec 2015
- First submitted
- 5 May 2015
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mills JT, Burris MB, Warburton DJ, Conaway MR, Schenkman NS, Krupski TL. Positioning injuries associated with robotic assisted urological surgery. J Urol. 2013 Aug;190(2):580-4. doi: 10.1016/j.juro.2013.02.3185. Epub 2013 Mar 1.
PubMed 23466240
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot Assisted Radical Prostatecomy and Positional Injury; 8 Years Survey
- ClinicalTrials.gov ID
- NCT02437695
- Acronym / sponsor ID
- GK3
- Conditions
- Peripheral Nerve Injuries
- Keywords
- Robotic Surgical Procedures, Trendelenburg Position
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- May 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 7 May 2015 (estimated)
- 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.
Although a condition for surgery, robotic interventions applied with steep Trendelenburg-lithotomy (ST-L) position may cause positional injury and peripheral neuropathy if good position is not achieved on the operating table. This study will be a 7-year retrospective examination of postoperative positional injury (PPI) in patients undergoing robot-assisted radical prostatectomy (RARP) for prostate diagnosis.
Detailed description
Patients who underwent RARP between 2008-2014 will be evaluate. Patients with known peripheral neuropathy, lumbar-cervical discopathy, or history of orthopaedic surgery or trauma will exclude. The demographic data of patients, ASA, Charlson Comorbidity Index (CMI), Body Mass Index (BMI), operating time (OT) and Trendelenburg time (TT) will obtain from patient records. Patients will be questioned as to whether or not PPI had developed, if so, in which extremity, in what form (sensory-motor), duration, whether or not a doctor had been consulted, if so, what treatment had been given and whether or not the PPI had continued.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing robot-assisted radical prostatectomy (RARP) for prostate diagnosis.
Key inclusion criteria (1 listed)
- Patients undergoing robot-assisted radical prostatectomy (RARP) for prostate diagnosis.
Key exclusion criteria (4 listed)
- Patients with known peripheral neuropathy,
- Lumbar-cervical discopathy,
- History of orthopaedic surgery or
- Trauma were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
retrospective examination of postoperative positional injury (PPI) in patients undergoing robot-assisted radical prostatectomy (RARP) for prostate diagnosis
Time frame: 7 years
The ST-L position carries high risk in terms of PPI, especially when lengthy surgery is planned and the risk could be increased in patients with high BMI.
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 8 Dec 2015.
- Results publication: PubMed 23466240Mills JT, Burris MB, Warburton DJ, Conaway MR, Schenkman NS, Krupski TL. Positioning injuries associated with robotic assisted urological surgery. J Urol. 2013 Aug;190(2):580-4. doi: 10.1016/j.juro.2013.02.3185. Epub 2013 Mar 1.
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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.
Nurten Bakan, MD study chair
Unraniye training and research hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Nerve Injuries, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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 8 Dec 2015. 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 Turkey (Türkiye). 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?
retrospective examination of postoperative positional injury (PPI) in patients undergoing robot-assisted radical prostatectomy (RARP) for prostate diagnosis (time frame: 7 years). 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 NCT02437695, which also lists 1 linked publication.
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 8 Dec 2015.