Steep Trendelenburg Positioning on Intra-Ocular Pressure... | NCT00852774

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

NCT00852774

Sponsor

Ohio State University Comprehensive Cancer Center

Status

Withdrawn

Last Update Posted

Jul 28, 2014Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Intraocular Pressure

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

terminated due to low staffing

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Feb 25, 2009

First Submission Date that Met QC Criteria

Feb 26, 2009

First Posted Date

Feb 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2014

Last Update Posted Date

Jul 28, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Cohn, Principal Investigator, Ohio State UniversityPrincipal Investigator

Lead Sponsor

Ohio State University Comprehensive Cancer CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Endometrial Cancer Patients Hysterectomy Robotic Surgery
2		Endometrial Cancer Patient Hysterectomy Laparotomy Surgery

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Endometrial Cancer Surgery

Exclusion Criteria:

Not a surgical candidate

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Endometrial Cancer Surgical Candidates

Sampling Method

Probability Sample