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A Retrospective Review Of Outcomes Following Laparoscopic Myomectomy (retromyo)

This study has been terminated.
(did not have resources to continue this study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00672750
First Posted: May 6, 2008
Last Update Posted: January 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Charles E Miller MD, The Advanced Gynecologic Surgery Institute
  Purpose
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.

Condition
Laparoscopic Myomectomy

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: A Retrospective Review Of Outcomes Following Laparoscopic Myomectomy

Resource links provided by NLM:


Further study details as provided by Charles E Miller MD, The Advanced Gynecologic Surgery Institute:

Primary Outcome Measures:
  • That patients who had pain prior to laparoscopic myomectomy will have less pain in 75% of the cases [ Time Frame: since 1999 ]

Secondary Outcome Measures:
  • That patients who had menorrhagia prior to laparoscopic myomectomy would see a reduction after surgery 75% of the time [ Time Frame: since 1999 ]

Enrollment: 70
Study Start Date: February 2008
Study Completion Date: September 16, 2016
Primary Completion Date: September 16, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
I
Patients of Dr C Miller who have undergone laparoscopic myomectomy from 1999- to present

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Private patients of Dr Charles Miller who have undergone laparoscopic myomectomy since 1999
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672750


Locations
United States, Illinois
Advanced Gynecologic Surgery Institute
Naperville, Illinois, United States, 60540
Sponsors and Collaborators
The Advanced Gynecologic Surgery Institute
Investigators
Principal Investigator: Charles E Miller, MD Advanced gynecologic surgery institute
  More Information

Responsible Party: Charles E Miller MD, Principal Investigator, The Advanced Gynecologic Surgery Institute
ClinicalTrials.gov Identifier: NCT00672750     History of Changes
Other Study ID Numbers: 23597
First Submitted: May 1, 2008
First Posted: May 6, 2008
Last Update Posted: January 26, 2017
Last Verified: January 2017

Keywords provided by Charles E Miller MD, The Advanced Gynecologic Surgery Institute:
laparoscopic
myomectomy
menorrhagia
pelvic pain