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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

Tracking Information
First Submitted Date  ICMJE April 30, 2012
First Posted Date  ICMJE May 2, 2012
Last Update Posted Date May 3, 2012
Study Start Date  ICMJE September 2004
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
  • Spillage of intracystic content rate [ Time Frame: Intraoperative ]
  • 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.
  • Chemical peritonitis rate [ Time Frame: 1 week after surgery ]
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2012)
  • Spillage of intracystic content rate [ Time Frame: Intraoperative ]
  • Operative times [ Time Frame: At the end of surgery ]
  • Chemical peritonitis rate [ Time Frame: 1 week after surgery ]
  • Intraoperative blood loss [ Time Frame: At the end of surgery ]
Change History Complete list of historical versions of study NCT01590030 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2012)
Ovarian reserve [ Time Frame: 3 months and 1 year after surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ovarian Mesial Incision: a New Safe and Fertility-sparing Technique
Official Title  ICMJE Mesial Incision for Laparoscopic Dermoid Cystectomy: a New Safe and Fertility-sparing Technique
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dermoid Ovarian Cysts
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Laparoscopic mesial incision
    Intervention: Procedure: Laparoscopic dermoid cystectomy
  • Active Comparator: Laparoscopic antimesial incision
    Intervention: Procedure: Laparoscopic dermoid cystectomy
Publications * Morelli M, Mocciaro R, Venturella R, Imperatore A, Lico D, Zullo F. Mesial side ovarian incision for laparoscopic dermoid cystectomy: a safe and ovarian tissue-preserving technique. Fertil Steril. 2012 Nov;98(5):1336-40.e1. doi: 10.1016/j.fertnstert.2012.07.1112. Epub 2012 Aug 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2012)
67
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01590030
Other Study ID Numbers  ICMJE Mesial Dermoid Incision
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fulvio Zullo, University Magna Graecia
Study Sponsor  ICMJE University Magna Graecia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fulvio Zullo, MD, PhD University Magna Graecia
PRS Account University Magna Graecia
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP