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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Magna Graecia
Sponsor:
Information provided by (Responsible Party):
Fulvio Zullo, University Magna Graecia
ClinicalTrials.gov Identifier:
NCT02086435
First received: March 9, 2014
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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 Intervention
Uterine Myoma
Procedure: Extracorporeal morcellation
Procedure: Intracorporeal morcellation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Operative time [ Time Frame: The day of surgery ] [ Designated as safety issue: Yes ]
    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:
  • Total operative time [ Time Frame: The day of surgery ] [ Designated as safety issue: Yes ]
    from skin incision to skin closure

  • Handling of morcellation [ Time Frame: The day of surgery ] [ Designated as safety issue: No ]
    expressed on the VAS scale where 1 means very bad handling and 10 excellent handling

  • Blood loss [ Time Frame: 2 hours after the end of surgery ] [ Designated as safety issue: Yes ]
    Blood loss will be calculated by the difference of Hb level 2 hours after surgery and the morning of the surgery

  • Postoperative hospital stay [ Time Frame: The day of patient discharge, average 4 day after surgery ] [ Designated as safety issue: Yes ]
  • Postoperative pain [ Time Frame: The day of patient discharge, average 4 day after surgery ] [ Designated as safety issue: Yes ]
    measured on the VAS scale where 1 stands for a little pain and 10 for intense pain

  • Rate of complications [ Time Frame: The day of patient discharge, average 4 day after surgery ] [ Designated as safety issue: Yes ]
    need of transfusion or laparotomic conversion


Estimated Enrollment: 92
Study Start Date: October 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02086435

Contacts
Contact: Fulvio Zullo, MD, PHD 39337947003 zullo@unicz.it

Locations
Italy
Chair of Obstetrics and Gynecology - University division - UMG Recruiting
Catanzaro, CZ, Italy, 88100
Contact: Fulvio Zullo    39337947003    zullo@unicz.it   
Sub-Investigator: Roberta Venturella, MD         
Sponsors and Collaborators
University Magna Graecia
Investigators
Principal Investigator: Fulvio Zullo Magna Graecia University of Catanzaro
  More Information

No publications provided

Responsible Party: Fulvio Zullo, Full Professor Obstetric Gynecology, University Magna Graecia
ClinicalTrials.gov Identifier: NCT02086435     History of Changes
Other Study ID Numbers: SafeMorcellation
Study First Received: March 9, 2014
Last Updated: March 12, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by University Magna Graecia:
Myomectomy
Laparoscopic myomectomy
Morcellation
Risk of dissemination
Uterine Sarcoma
Parasitic myoma

Additional relevant MeSH terms:
Myoma
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 22, 2014