Robot-Assisted Laparoscopic Myomectomy Is an Improvement... | NCT00910468

Studies
Robot-Assisted Laparoscopic Myomectomy Is an Improvement Over Laparotomy in Patients With a Limited Number of Fibroids

NCT00910468

Sponsor

Ascher-Walsh, Charles, M.D.

Status

Completed

Last Update Posted

May 29, 2009Estimated

Enrollment

150Actual

Phase

Not provided

Conditions

Fibroid Uterus

Interventions

Robot-assisted Laparoscopic myomectomy

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

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

May 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

May 28, 2009

First Submission Date that Met QC Criteria

May 28, 2009

First Posted Date

May 29, 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

May 28, 2009

Last Update Posted Date

May 29, 2009Estimated

Description Module

Brief Summary

This is a retrospective, case-control study of 75 patients having undergone a robotic-assisted laparoscopic myomectomy were compared to patients having undergone myomectomy via laparotomy. Both groups had 3 or fewer fibroids confirmed by pre-operative MRI or on final pathology report. Charts were reviewed for surgical and post-operative variables

Detailed Description

Not provided

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

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Robot Assisted Laparoscopic Myomectomy			Procedure: Robot-assisted Laparoscopic myomectomy
Myomectomy via Laparotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Robot-assisted Laparoscopic myomectomy	Procedure	Robot-assisted Laparoscopic myomectomy	Robot Assisted Laparoscopic Myomectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-operative variables, including estimated blood loss, length of stay, days to a regular diet and febrile morbidity		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

uterus less than or equal to 20 weeks in size by office exam and no greater than three intramural fibroids on pre-operative MRI.

Exclusion Criteria:

significant medical problems limiting their ability to undergo a prolonged laparoscopic procedure and could not have had previous uterine surgery.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Women with fibroid uterus desiring surgical management

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles Ascher-Walsh, MD, MPH	Mt Sinai School of Medicine, Dept Obstetrics and Gynecology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mount SInai School of Medicine		New York	New York	10029	United States

Condition Browse Module

MeSH Terms

ID	Term
D007889	Leiomyoma

Ancestor Terms

ID	Term
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided