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Ovarian Mesial Incision: a New Safe and Fertility-sparing Technique

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.
 
ClinicalTrials.gov Identifier: NCT01590030
Recruitment Status : Completed
First Posted : May 2, 2012
Last Update Posted : May 3, 2012
Sponsor:
Information provided by (Responsible Party):
Fulvio Zullo, University Magna Graecia

Study Description
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Brief Summary:
The purpose of this study is to evaluate safety and efficacy in terms of spillage risk and fertility-sparing of mesial incision for laparoscopic dermoid cystectomy.

Condition or disease Intervention/treatment Phase
Dermoid Ovarian Cysts Procedure: Laparoscopic dermoid cystectomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mesial Incision for Laparoscopic Dermoid Cystectomy: a New Safe and Fertility-sparing Technique
Study Start Date : September 2004
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2011
Arms and Interventions
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Arm Intervention/treatment
Experimental: Laparoscopic mesial incision Procedure: Laparoscopic dermoid cystectomy
Laparoscopy will be performed by pneumoperitoneum with CO2. A complete pelvic examination will be performed to exclude malignant disease. Ovarian capsule will be incised by scissors on mesial side in study group and antimesial side in control group. After cleavage plane identification the cyst enucleation will be completed by atraumatic dissection.
Active Comparator: Laparoscopic antimesial incision Procedure: Laparoscopic dermoid cystectomy
Laparoscopy will be performed by pneumoperitoneum with CO2. A complete pelvic examination will be performed to exclude malignant disease. Ovarian capsule will be incised by scissors on mesial side in study group and antimesial side in control group. After cleavage plane identification the cyst enucleation will be completed by atraumatic dissection.


Outcome Measures
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Primary Outcome Measures :
  1. Spillage of intracystic content rate [ Time Frame: Intraoperative ]
  2. Operative times [ Time Frame: Immediately at the end of the laparoscopy ]
    Operative times will be assessed when surgeons will end the laparoscopy, specifically when he will end the suture of the last skin scar.

  3. Chemical peritonitis rate [ Time Frame: 1 week after surgery ]
  4. Intraoperative blood loss [ Time Frame: The morning after laparoscopy ]
    The first patient blood sample will be taken the morning of the surgery, at h 8 am. The day after, it will be taken the second blood sample. Intraoperative blood loss wil be calculated by deducting Hb values of the second hemocrome by the first one.


Secondary Outcome Measures :
  1. Ovarian reserve [ Time Frame: 3 months and 1 year after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • reproductive age
  • pre-operative findings suggestive for benign tumor
  • regular menstrual cycles at least six months before surgery

Exclusion Criteria:

  • previous pelvic surgery
  • known endocrine disease
  • estrogen-progestin use before surgery
Contacts and Locations
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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): NCT01590030


Locations
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Italy
Chair of Obstetrics and Gynecology
Catanzaro, CZ, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Investigators
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Principal Investigator: Fulvio Zullo, MD, PhD University Magna Graecia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fulvio Zullo, Full Professor, University Magna Graecia
ClinicalTrials.gov Identifier: NCT01590030    
Other Study ID Numbers: Mesial Dermoid Incision
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: May 3, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Ovarian Cysts
Dermoid Cyst
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Teratoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type