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

U

University Magna Graecia

Status

Completed

Conditions

Dermoid Ovarian Cysts

Treatments

Procedure: Laparoscopic dermoid cystectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01590030
Mesial Dermoid Incision

Details and patient eligibility

About

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.

Enrollment

67 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

67 participants in 2 patient groups

Laparoscopic mesial incision
Experimental group
Treatment:
Procedure: Laparoscopic dermoid cystectomy
Laparoscopic antimesial incision
Active Comparator group
Treatment:
Procedure: Laparoscopic dermoid cystectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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