NCT00852774

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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2009

Typical duration for all trials

Status
withdrawn

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

First Submitted

Initial submission to the registry

February 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

July 28, 2014

Status Verified

July 1, 2014

Enrollment Period

2.3 years

First QC Date

February 25, 2009

Last Update Submit

July 25, 2014

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (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

    5years for enrollment completion

Study Arms (2)

1

Endometrial Cancer Patients Hysterectomy Robotic Surgery

2

Endometrial Cancer Patient Hysterectomy Laparotomy Surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Endometrial Cancer Surgical Candidates

You may qualify if:

  • Endometrial Cancer Surgery

You may not qualify if:

  • Not a surgical candidate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • David Cohn, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 27, 2009

Study Start

May 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

July 28, 2014

Record last verified: 2014-07