A Retrospective Review Of Outcomes Following Laparoscopic... | NCT00672750

Studies
A Retrospective Review Of Outcomes Following Laparoscopic Myomectomy

NCT00672750

Sponsor

The Advanced Gynecologic Surgery Institute

Status

Terminated

Last Update Posted

Jan 26, 2017Estimated

Enrollment

70Actual

Phase

Not provided

Conditions

Laparoscopic Myomectomy

Interventions

Not provided

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

Jan 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

did not have resources to continue this study

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Sep 16, 2016Actual

Completion Date

Sep 16, 2016Actual

First Submitted Date

May 1, 2008

First Submission Date that Met QC Criteria

May 5, 2008

First Posted Date

May 6, 2008Estimated

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

Jan 24, 2017

Last Update Posted Date

Jan 26, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Charles E Miller MD, Principal Investigator, The Advanced Gynecologic Surgery InstitutePrincipal Investigator

Lead Sponsor

The Advanced Gynecologic Surgery InstituteOTHER

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

This will be a retrospective review of approximately 900 patients who have undergone laparoscopic myomectomy since 1999. patients will be contacted by phone and surveyed. All patients who have had laparoscopic myomectomy will be included. Only those not wishing to take part in the survey will be excluded. The data will then be compiled for statistical analysis , looking at pain, bleeding and subsequent fertility.

Detailed Description

Patients will be called and surveyed using a survey tool. They will be asked about what factors lead them to have surgery and then was their issue resolved after surgery.

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

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I		Patients of Dr C Miller who have undergone laparoscopic myomectomy from 1999- to present

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
That patients who had pain prior to laparoscopic myomectomy will have less pain in 75% of the cases		since 1999

Secondary Outcomes

Measure	Description	Time Frame
That patients who had menorrhagia prior to laparoscopic myomectomy would see a reduction after surgery 75% of the time		since 1999

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients who are willing to be surveyed

Exclusion Criteria:

Those patients who are not willing to answer the survey will be excluded
- Those patients who are unable to be contacted( ie; moved) will be excluded

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Private patients of Dr Charles Miller who have undergone laparoscopic myomectomy since 1999

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles E Miller, MD	Advanced gynecologic surgery institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Advanced Gynecologic Surgery Institute		Naperville	Illinois	60540	United States

Condition Browse Module

MeSH Terms

ID	Term
D008595	Menorrhagia
D017699	Pelvic Pain

Ancestor Terms

ID	Term
D014592	Uterine Hemorrhage
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided