Robot Assisted Radical Prostatecomy and Positional Injury

Peripheral Nerve Injuries Clinical Trial

Official title:

Robot Assisted Radical Prostatecomy and Positional Injury; 8 Years Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02437695
• Other study ID #: GK3
• Status: Completed
• Phase: N/A
• First received: May 5, 2015
• Last updated: December 7, 2015
• Start date: May 2015
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Umraniye Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Peripheral Nerve Injuries

Locations

Country	Name	City	State
Turkey	Istanbul Umraniye Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 years	No