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

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ClinicalTrials.gov Identifier: NCT00852774
Recruitment Status : Withdrawn (terminated due to low staffing)
First Posted : February 27, 2009
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):
David Cohn, Ohio State University

Brief Summary:
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.

Condition or disease
Intraocular Pressure

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Steep Trendelenburg Positioning on Intra-Ocular Pressure During Surgery For Endometrial Cancer: Robotics Versus Laparotomy
Study Start Date : May 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
1
Endometrial Cancer Patients Hysterectomy Robotic Surgery
2
Endometrial Cancer Patient Hysterectomy Laparotomy Surgery



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Endometrial Cancer Surgical Candidates
Criteria

Inclusion Criteria:

  • Endometrial Cancer Surgery

Exclusion Criteria:

  • Not a surgical candidate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852774


Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: David Cohn, MD Ohio State University

Responsible Party: David Cohn, Principal Investigator, Ohio State University
ClinicalTrials.gov Identifier: NCT00852774     History of Changes
Obsolete Identifiers: NCT01375192
Other Study ID Numbers: OSU-08159
First Posted: February 27, 2009    Key Record Dates
Last Update Posted: July 28, 2014
Last Verified: July 2014