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

Primary Purpose

Dermoid Ovarian Cysts

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Laparoscopic dermoid cystectomy
Sponsored by
University Magna Graecia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermoid Ovarian Cysts

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Chair of Obstetrics and Gynecology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic mesial incision

Laparoscopic antimesial incision

Arm Description

Outcomes

Primary Outcome Measures

Spillage of intracystic content rate
Operative times
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
Intraoperative blood loss
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

Full Information

First Posted
April 30, 2012
Last Updated
May 2, 2012
Sponsor
University Magna Graecia
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1. Study Identification

Unique Protocol Identification Number
NCT01590030
Brief Title
Ovarian Mesial Incision: a New Safe and Fertility-sparing Technique
Official Title
Mesial Incision for Laparoscopic Dermoid Cystectomy: a New Safe and Fertility-sparing Technique
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Magna Graecia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermoid Ovarian Cysts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic mesial incision
Arm Type
Experimental
Arm Title
Laparoscopic antimesial incision
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic dermoid cystectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spillage of intracystic content rate
Time Frame
Intraoperative
Title
Operative times
Description
Operative times will be assessed when surgeons will end the laparoscopy, specifically when he will end the suture of the last skin scar.
Time Frame
Immediately at the end of the laparoscopy
Title
Chemical peritonitis rate
Time Frame
1 week after surgery
Title
Intraoperative blood loss
Description
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.
Time Frame
The morning after laparoscopy
Secondary Outcome Measure Information:
Title
Ovarian reserve
Time Frame
3 months and 1 year after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fulvio Zullo, MD, PhD
Organizational Affiliation
University Magna Graecia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chair of Obstetrics and Gynecology
City
Catanzaro
State/Province
CZ
ZIP/Postal Code
88100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22884658
Citation
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.
Results Reference
derived

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

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