Steep Trendelenburg Positioning on Intra-Ocular Pressure During Surgery for Endometrial Robotics Versus Laparotomy

This study has been withdrawn prior to enrollment.
(terminated due to low staffing)
Sponsor:
Information provided by (Responsible Party):
David Cohn, Ohio State University
ClinicalTrials.gov Identifier:
NCT00852774
First received: February 25, 2009
Last updated: July 25, 2014
Last verified: July 2014

February 25, 2009
July 25, 2014
May 2009
August 2011   (final data collection date for primary outcome measure)
To assess the changes in intra-ocular pressure and examine perioperative factors affecting IOP in endometrial cancer patients undergoing robotic hysterectomy compared to a laparotomy [ Time Frame: 5years for enrollment completion ] [ Designated as safety issue: No ]
To assess the changes in intra-ocular pressure and examine perioperative factors affecting IOP in endometrial cancer patients undergoing robotic hysterectomy compared to a laparotomy [ Time Frame: 5years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00852774 on ClinicalTrials.gov Archive Site
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Steep Trendelenburg Positioning on Intra-Ocular Pressure During Surgery for Endometrial Robotics Versus Laparotomy
Effects of Steep Trendelenburg Positioning on Intra-Ocular Pressure During Surgery For Endometrial Cancer: Robotics Versus Laparotomy

The purpose of this study is to assess changes of intra-ocular pressure (IOP) and examine preoperative facts affecting IOP in endometrial cancer patients undergoing robotic hysterectomy compared to laparotomy.

All patients that are surgical candidates with endometrial cancer will be screened for this study. Two measurements from each eye will be taken in the following positions: awake at rest, supine before induction, after induction on anesthesia, after insufflation of abdomen with CO2 in supine position, in trendelenburg position, in deep trendelenburg position,at the end of procedure,prior to awakening in supine position and one last reading 45-60 min after awakening in supine position. The time, blood pressure, heart rate, peak airway pressure, plateau airway pressure, end tidal desflurane, end tidal CO2, total IV fluids administered, and blood loss.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Endometrial Cancer Surgical Candidates

Intraocular Pressure
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  • 1
    Endometrial Cancer Patients Hysterectomy Robotic Surgery
  • 2
    Endometrial Cancer Patient Hysterectomy Laparotomy Surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Endometrial Cancer Surgery

Exclusion Criteria:

  • Not a surgical candidate
Female
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00852774
OSU-08159
No
David Cohn, Ohio State University
Ohio State University Comprehensive Cancer Center
Not Provided
Principal Investigator: David Cohn, MD Ohio State University
Ohio State University Comprehensive Cancer Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP