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

NCT ID: NCT01590030

Last Updated: 2012-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2011-01-31

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.

Detailed Description

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Conditions

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Dermoid Ovarian Cysts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Laparoscopic mesial incision

Group Type EXPERIMENTAL

Laparoscopic dermoid cystectomy

Intervention Type 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.

Laparoscopic antimesial incision

Group Type ACTIVE_COMPARATOR

Laparoscopic dermoid cystectomy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Magna Graecia

OTHER

Sponsor Role lead

Responsible Party

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Fulvio Zullo

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fulvio Zullo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Magna Graecia

Locations

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Chair of Obstetrics and Gynecology

Catanzaro, CZ, Italy

Site Status

Countries

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Italy

References

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Morelli M, Mocciaro R, Venturella R, Imperatore A, Lico D, Zullo F. Mesial side ovarian incision for laparoscopic dermoid cystectomy: a safe and ovarian tissue-preserving technique. Fertil Steril. 2012 Nov;98(5):1336-40.e1. doi: 10.1016/j.fertnstert.2012.07.1112. Epub 2012 Aug 11.

Reference Type DERIVED
PMID: 22884658 (View on PubMed)

Other Identifiers

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Mesial Dermoid Incision

Identifier Type: -

Identifier Source: org_study_id

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