Dermoid Ovarian Cysts
Conditions
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.
Interventions
PROCEDURELaparoscopic 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.
Sponsors
University Magna Graecia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative times | 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 | 1 week after surgery | — |
| Spillage of intracystic content rate | Intraoperative | — |
| Intraoperative blood loss | 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
| Measure | Time frame |
|---|---|
| Ovarian reserve | 3 months and 1 year after surgery |
Countries
Italy
Outcome results
None listed