Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes

Last updated: April 19, 2015
Sponsor: University Magna Graecia
Overall Status: Completed

Phase

N/A

Condition

Sarcoma (Pediatric)

Uterina Myoma

Uterine Fibroids

Treatment

N/A

Clinical Study ID

NCT02086435
SafeMorcellation
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study Summary

The aim of this study protocol will be to compare the technique of intracorporeal morcellation using reusable electronic device (standard technique) with a technique of removal "protected" by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients undergoing laparoscopy for uterine myomas with international guidelinessurgical indications

  • Presence of at least one uterine myoma larger than 4 cm

  • Aged between 18 and 40 years

Exclusion

Exclusion Criteria:

  • Presence of uterine neoformations suspicious for malignancy

  • Medical major disorders associated

  • Acute or chronic psychiatric disorders

  • Ascertained Premenstrual syndrome

  • Use of drugs that can affect cognitive ability or state of consciousness and alertnessduring the last six months prior to enrollment

  • Presence of calcified fibroids ultrasound examination

  • Presence of adnexal lesions

  • Detection of a pattern of endometrial hyperplasia with atypia determined in the courseendometrial biopsy performed for abnormal uterine bleeding

  • Abnormal PAP test

  • Positive Pregnancy Test

  • Previous use of laparoscopic surgery increased

Study Design

Total Participants: 93
Study Start date:
March 01, 2014
Estimated Completion Date:
April 30, 2015

Connect with a study center

  • Chair of Obstetrics and Gynecology - University division - UMG

    Catanzaro, CZ 88100
    Italy

    Site Not Available

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