Robot Assisted Radical Prostatecomy and Positional Injury

NCT ID: NCT02437695

Last Updated: 2015-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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

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Peripheral Nerve Injuries

Study Design

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Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing robot-assisted radical prostatectomy (RARP) for prostate diagnosis.

Exclusion Criteria

* Patients with known peripheral neuropathy,
* Lumbar-cervical discopathy,
* History of orthopaedic surgery or
* Trauma were excluded
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gulsah Karaoren

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nurten Bakan, MD

Role: STUDY_CHAIR

Unraniye training and research hospital

Locations

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Istanbul Umraniye Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 23466240 (View on PubMed)

Other Identifiers

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GK3

Identifier Type: -

Identifier Source: org_study_id