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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fulvio Zullo, University Magna Graecia
ClinicalTrials.gov Identifier:
NCT01590030
First received: April 30, 2012
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Dermoid Ovarian Cysts
 Procedure: Laparoscopic dermoid cystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mesial Incision for Laparoscopic Dermoid Cystectomy: a New Safe and Fertility-sparing Technique

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Spillage of intracystic content rate [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]
  • Operative times [ Time Frame: Immediately at the end of the laparoscopy ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Intraoperative blood loss [ Time Frame: The morning after laparoscopy ] [ Designated as safety issue: Yes ]
    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:
  • Ovarian reserve [ Time Frame: 3 months and 1 year after surgery ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: September 2004
Study Completion Date: January 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590030

Locations
Italy
Chair of Obstetrics and Gynecology
Catanzaro, CZ, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Investigators
Principal Investigator: Fulvio Zullo, MD, PhD University Magna Graecia
  More Information

No publications provided by University Magna Graecia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Fulvio Zullo, Full Professor, University Magna Graecia
ClinicalTrials.gov Identifier: NCT01590030     History of Changes
Other Study ID Numbers: Mesial Dermoid Incision
Study First Received: April 30, 2012
Last Updated: May 2, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Dermoid Cyst
Ovarian Cysts
Cysts
Neoplasms
Teratoma
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013