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Clinical Trials/NCT02437695
NCT02437695
Completed
Not Applicable

Robot Assisted Radical Prostatecomy and Positional Injury; 8 Years Survey

Umraniye Education and Research Hospital1 site in 1 country450 target enrollmentMay 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Nerve Injuries
Sponsor
Umraniye Education and Research Hospital
Enrollment
450
Locations
1
Primary Endpoint
retrospective examination of postoperative positional injury (PPI) in patients undergoing robot-assisted radical prostatectomy (RARP) for prostate diagnosis
Status
Completed
Last Updated
10 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
July 2015
Last Updated
10 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Umraniye Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Gulsah Karaoren

MD

Umraniye Education and Research Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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