Ovarian Mesial Incision: a New Safe and Fertility-sparing Technique
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ClinicalTrials.gov Identifier: NCT01590030 |
Recruitment Status :
Completed
First Posted : May 2, 2012
Last Update Posted : May 3, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dermoid Ovarian Cysts | Procedure: Laparoscopic dermoid cystectomy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 67 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Mesial Incision for Laparoscopic Dermoid Cystectomy: a New Safe and Fertility-sparing Technique |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | January 2011 |
Arm | Intervention/treatment |
---|---|
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. |
- Spillage of intracystic content rate [ Time Frame: Intraoperative ]
- Operative times [ Time Frame: 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 [ Time Frame: 1 week after surgery ]
- Intraoperative blood loss [ Time Frame: 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.
- Ovarian reserve [ Time Frame: 3 months and 1 year after surgery ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590030
Italy | |
Chair of Obstetrics and Gynecology | |
Catanzaro, CZ, Italy, 88100 |
Principal Investigator: | Fulvio Zullo, MD, PhD | University Magna Graecia |
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 |
First Posted: | May 2, 2012 Key Record Dates |
Last Update Posted: | May 3, 2012 |
Last Verified: | May 2012 |
Ovarian Cysts Dermoid Cyst Cysts Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Teratoma Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |