NCT02437695

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

1 month

First QC Date

May 5, 2015

Last Update Submit

December 7, 2015

Conditions

Peripheral Nerve Injuries

Keywords

Robotic Surgical ProceduresTrendelenburg Position

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age45 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients with known peripheral neuropathy,
  • Lumbar-cervical discopathy,
  • History of orthopaedic surgery or
  • Trauma were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Umraniye Training Hospital

Istanbul, Turkey (Türkiye)

Location

Related 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.

    PMID: 23466240RESULT

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Nurten Bakan, MD

    Unraniye training and research hospital

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 5, 2015

First Posted

May 7, 2015

Study Start

May 1, 2015

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations

TU(1)