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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 February 2016 |
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Main ID: |
NCT02308995 |
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Date of registration:
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03/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma
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Scientific title:
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Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma . A Randomized Controlled Study |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02308995 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Usama M. Fouda, M.D , PhD |
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Address:
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Telephone:
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01095401375 |
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Email:
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umfrfouda@yahoo.com |
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Affiliation:
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Name:
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Usama M Fouda, M.D,PhD |
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Address:
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Telephone:
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01095401375 |
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Email:
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umfrfouda@yahoo.com |
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Affiliation:
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Name:
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Usama M Fouda, M.D,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Aljazeera Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Unilateral endometrioma more than 3 cm in mean diameter
Exclusion Criteria:
- Bilateral endometriomata
- Conversion of laparoscopy to laparotomy
- Contraindications for general anesthesia
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Endometriosis
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Intervention(s)
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Device: polyglactin 910 suture(VICRYL™, Ethicon Inc, Sommerville, NJ)
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Procedure: Cystectomy using barbed sutures
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Procedure: Cystectomy using conventional sutures
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Device: V-Loc (Covidien, Mansfield, MA)
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Primary Outcome(s)
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Suturing time of endometrioma bed
[Time Frame: During cystectomy operation]
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Secondary Outcome(s)
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Operative time
[Time Frame: During cystectomy operation]
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Secondary ID(s)
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lap.cystectomy.barbed
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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