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

This study has been terminated.
(terminated due to low staffing)
Sponsor:
Information provided by (Responsible Party):
David Cohn, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00852774
First received: February 25, 2009
Last updated: March 28, 2012
Last verified: March 2012
History of Changes
  Purpose

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
Intraocular Pressure

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 85
Study Start Date: February 2009
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Endometrial Cancer Patients Hysterectomy Robotic Surgery
2
Endometrial Cancer Patient Hysterectomy Laparotomy Surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852774

Locations
United States, Ohio
OSU Gyn Oncology at Mill Run
Hilliard, Ohio, United States, 43026
Sponsors and Collaborators
David Cohn
Investigators
Principal Investigator: David Cohn, MD Ohio State University
  More Information

No publications provided

Responsible Party: David Cohn, Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00852774     History of Changes
Obsolete Identifiers: NCT01375192
Other Study ID Numbers: 2009CO003
Study First Received: February 25, 2009
Last Updated: March 28, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013