A Retrospective Review Of Outcomes Following Laparoscopic Myomectomy (retromyo)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Charles E Miller MD, The Advanced Gynecologic Surgery Institute
ClinicalTrials.gov Identifier:
NCT00672750
First received: May 1, 2008
Last updated: September 3, 2013
Last verified: September 2013
  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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: February 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   16 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672750

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

No publications provided

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
Study First Received: May 1, 2008
Last Updated: September 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Advanced Gynecologic Surgery Institute:
laparoscopic
myomectomy
menorrhagia
pelvic pain

ClinicalTrials.gov processed this record on October 21, 2014