NCT00672750

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2008

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2016

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

8.6 years

First QC Date

May 1, 2008

Last Update Submit

January 24, 2017

Conditions

Keywords

laparoscopicmyomectomymenorrhagiapelvic pain

Outcome Measures

Primary Outcomes (1)

  • That patients who had pain prior to laparoscopic myomectomy will have less pain in 75% of the cases

    since 1999

Secondary Outcomes (1)

  • That patients who had menorrhagia prior to laparoscopic myomectomy would see a reduction after surgery 75% of the time

    since 1999

Study Arms (1)

I

Patients of Dr C Miller who have undergone laparoscopic myomectomy from 1999- to present

Eligibility Criteria

Age16 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • All patients who are willing to be surveyed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Gynecologic Surgery Institute

Naperville, Illinois, 60540, United States

Location

MeSH Terms

Conditions

MenorrhagiaPelvic Pain

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation DisturbancesPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Charles E Miller, MD

    Advanced gynecologic surgery institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 1, 2008

First Posted

May 6, 2008

Study Start

February 1, 2008

Primary Completion

September 16, 2016

Study Completion

September 16, 2016

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations