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OpenTrials
Completed

NCT Number: NCT01590030

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

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.

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Key information

Conditions

Dermoid Ovarian Cysts

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chair of Obstetrics and Gynecology

Catanzaro, CZ, 88100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic dermoid cystectomy

Procedure

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 outcomes

  1. Spillage of intracystic content rate

    Time frame: Intraoperative

  2. 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.

  3. Chemical peritonitis rate

    Time frame: 1 week after surgery

  4. 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.

Secondary outcomes

  1. Ovarian reserve

    Time frame: 3 months and 1 year after surgery

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2011
First posted
May 2, 2012
Registry last updated
May 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.