A Trial on Laparoscopic Hysterectomy Versus Robotic Hyste... | NCT00895284

Studies
A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy

NCT00895284

Sponsor

Mayo Clinic

Status

Terminated

Last Update Posted

Jun 28, 2013Estimated

Enrollment

3Actual

Phase

Phase 4

Conditions

Hysterectomy

Interventions

Robotic hysterectomy
Standard Hysterectomy

Countries

United States

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

Participant Flow Module

Pre-assignment Details

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

May 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of funding

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

May 6, 2009

First Submission Date that Met QC Criteria

May 7, 2009

First Posted Date

May 8, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

May 9, 2013

Results First Submitted that Met QC Criteria

May 9, 2013

Results First Posted Date

Jun 28, 2013Estimated

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

May 9, 2013

Last Update Posted Date

Jun 28, 2013Estimated

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

Robotic technology has been used for laparoscopic hysterectomies for over 10 years. Mayo Clinic Arizona has used robotics in Gynecology for the last 10 years with well over 500 procedures performed. Similar to the laparoscopic approach, small incisions are utilized with the robotic approach. Robotic instruments differ from laparoscopic instruments in that the tips of the instruments can rotate more like the human wrist. The instruments are attached to the robotic arms which are controlled by your surgeon. The surgeon is seated at the surgeon's console which is located 12 feet from the patient while the surgical assistant is at your bedside assisting in the procedure.

This study is being done to compare the procedure times and results after laparoscopic hysterectomies to laparoscopic hysterectomies performed with robotic assistance.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Robot	Experimental	Robotic hysterectomy	Procedure: Robotic hysterectomy
Standard	Active Comparator	Standard hysterectomy	Procedure: Standard Hysterectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Robotic hysterectomy	Procedure	Robotic hysterectomy.	Robot
Standard Hysterectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Procedure Time - Skin Incision to Skin Closure		At skin closure.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- All subjects eligible for a laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy, and with or without appendectomy will be recruited.

Exclusion Criteria:

- Patients with malignant disease, pregnancy, gynecologic infection, or requiring procedure on an emergent basis.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rosanne Kho, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Scottsdale	Arizona	85253	United States

ID	Title	Description
FG000	Robot	Robotic hysterectomy
FG001	Standard	Standard hysterectomy

Baseline Characteristics Module

Baseline Analysis Population Description

Not provided

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	Robot	Robotic hysterectomy
BG001	Standard	Standard hysterectomy
BG002

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Categorical			Number

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Total Procedure Time - Skin Incision to Skin Closure

The study was terminated due to lack of funding; due to the small sample size, no analysis was done.

Posted

At skin closure.

ID	Title	Description
OG000	Robot	Robotic hysterectomy
OG001	Standard	Standard hysterectomy

Units	Counts
Participants

Adverse Events Module

Frequency Threshold

Time Frame

Not provided

Description

Not provided

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Robot	Robotic hysterectomy

Serious Adverse Events

Not provided

Other Adverse Events

Not provided

More Info Module

Limitations and Caveats

The study was terminated due to lack of funding.

Certain Agreements

Are all PI(s) employees of the sponsor?

Yes

Point of Contact

Title	Organization	Phone	Extension	Email
Dr. Rosanne Kho	Mayo Clinic	408-301-5811		kho.rosanne@mayo.edu