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Completed

NCT Number: NCT02437695

Robot Assisted Radical Prostatecomy and Positional Injury

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.

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Key information

Age range

45 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

Istanbul Umraniye Training Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Umraniye Education and Research Hospital

Other Gov

Registry information

Official study title

Robot Assisted Radical Prostatecomy and Positional Injury; 8 Years Survey

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 7, 2015
Registry last updated
Dec 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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