A Retrospective Review Of Outcomes Following Laparoscopic Myomectomy (retromyo)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by The Advanced Gynecologic Surgery Institute.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
The Advanced Gynecologic Surgery Institute
Collaborator:
Ethicon Endo-Surgery
Information provided by:
The Advanced Gynecologic Surgery Institute
ClinicalTrials.gov Identifier:
NCT00672750
First received: May 1, 2008
Last updated: May 5, 2008
Last verified: May 2008
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 1, 2008 | ||||
| Last Updated Date | May 5, 2008 | ||||
| Start Date ICMJE | February 2008 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00672750 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Retrospective Review Of Outcomes Following Laparoscopic Myomectomy | ||||
| Official Title ICMJE | A Retrospective Review Of Outcomes Following Laparoscopic Myomectomy | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Crossover Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Private patients of Dr Charles Miller who have undergone laparoscopic myomectomy since 1999 |
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| Condition ICMJE | Laparoscopic Myomectomy | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | I
Patients of Dr C Miller who have undergone laparoscopic myomectomy from 1999- to present |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 900 | ||||
| Estimated Completion Date | December 2010 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 16 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00672750 | ||||
| Other Study ID Numbers ICMJE | 23597 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Charles E Miller. MD, Advanced Gynecologic Surgery Institute | ||||
| Study Sponsor ICMJE | The Advanced Gynecologic Surgery Institute | ||||
| Collaborators ICMJE | Ethicon Endo-Surgery | ||||
| Investigators ICMJE |
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| Information Provided By | The Advanced Gynecologic Surgery Institute | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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