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IEME: Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes

Sponsor
University Magna Graecia (Other)
Overall Status
Completed
CT.gov ID
NCT02086435
Collaborator
(none)
93
Enrollment
1
Location
2
Arms
13
Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Extracorporeal morcellation
  • Procedure: Intracorporeal morcellation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
93 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Randomized Controlled Trial on Intracorporeal Versus Extracorporeal Morcellation With Endobag Extraction in Patients Undergoing Laparoscopic Myomectomy: Clinical Efficacy and Safety Outcomes
Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Extracorporeal morcellation

Extracorporeal morcellation in which patients are treated with "protected" removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself

Procedure: Extracorporeal morcellation
patients treated with "protected" removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself
Other Names:
  • protected morcellation
  • morcellation in endobag

    		•
    Active Comparator: Intracorporeal morcellation

    Intracorporeal morcellation patients treated with standard intracorporeal morcellation, using reusable electronic device

    Procedure: Intracorporeal morcellation
    patients treated with standard intracorporeal morcellation, using reusable electronic device
    Other Names:
  • Power morcellation
  • Standard intracorporeal morcellation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Operative time [The day of surgery]

      calculated from the time, after secured hemostasis of the uterine breach, in which the myoma is clamped and subjected to intracorporeal or added in endobag for extracorporeal morcellation to the moment when the 'last fragment of myoma will be considered removed from the surgical field

    Secondary Outcome Measures

    1. Total operative time [The day of surgery]

      from skin incision to skin closure

    2. Handling of morcellation [The day of surgery]

      expressed on the VAS scale where 1 means very bad handling and 10 excellent handling

    3. Blood loss [2 hours after the end of surgery]

      Blood loss will be calculated by the difference of Hb level 2 hours after surgery and the morning of the surgery

    4. Postoperative hospital stay [The day of patient discharge, average 4 day after surgery]

    5. Postoperative pain [The day of patient discharge, average 4 day after surgery]

      measured on the VAS scale where 1 stands for a little pain and 10 for intense pain

    6. Rate of complications [The day of patient discharge, average 4 day after surgery]

      need of transfusion or laparotomic conversion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patients undergoing laparoscopy for uterine myomas with international guidelines surgical indications

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

    • Aged between 18 and 40 years

    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 alertness during 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 course endometrial biopsy performed for abnormal uterine bleeding

    • Abnormal PAP test

    • Positive Pregnancy Test

    • Previous use of laparoscopic surgery increased

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chair of Obstetrics and Gynecology - University division - UMG Catanzaro CZ Italy 88100

    Sponsors and Collaborators

    • University Magna Graecia

    Investigators

    • Principal Investigator: Fulvio Zullo, Magna Graecia University of Catanzaro

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fulvio Zullo, Full Professor Obstetric Gynecology, University Magna Graecia
    ClinicalTrials.gov Identifier:
    NCT02086435
    Other Study ID Numbers:
    • SafeMorcellation
    First Posted:
    Mar 13, 2014
    Last Update Posted:
    Apr 21, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Fulvio Zullo, Full Professor Obstetric Gynecology, University Magna Graecia
    Myomectomy
    Laparoscopic myomectomy
    Morcellation
    Risk of dissemination
    Uterine Sarcoma
    Parasitic myoma
    Additional relevant MeSH terms:
    Leiomyoma
    Myofibroma

    Study Results

    No Results Posted as of Apr 21, 2015