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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dermoid Ovarian Cysts

Intervention / Treatment
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* Procedure: Laparoscopic dermoid cystectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic mesial incision<br> | Procedure: Laparoscopic dermoid cystectomy<br>* 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.<br>|
| Active Comparator: Laparoscopic antimesial incision<br> | Procedure: Laparoscopic dermoid cystectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spillage of intracystic content rate |  | Intraoperative | 
| 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 | 
| Chemical peritonitis rate |  | 1 week after surgery | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian reserve |  | 3 months and 1 year after surgery |