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

Dermoid Ovarian Cysts Clinical Trial

Official title:

Mesial Incision for Laparoscopic Dermoid Cystectomy: a New Safe and Fertility-sparing Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01590030
• Other study ID #: Mesial Dermoid Incision
• Status: Completed
• Phase: N/A
• First received: April 30, 2012
• Last updated: May 2, 2012
• Start date: September 2004
• Est. completion date: January 2011

Study information

• Verified date: May 2012
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermoid Ovarian Cysts
• Ovarian Cysts

Intervention

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.

Locations

Country	Name	City	State
Italy	Chair of Obstetrics and Gynecology	Catanzaro	CZ

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spillage of intracystic content rate		Intraoperative	Yes
Primary	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.	Immediately at the end of the laparoscopy	No
Primary	Chemical peritonitis rate		1 week after surgery	Yes
Primary	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.	The morning after laparoscopy	Yes
Secondary	Ovarian reserve		3 months and 1 year after surgery	No