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

Primary Purpose

Uterine Myoma

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Extracorporeal morcellation
Intracorporeal morcellation
Sponsored by
University Magna Graecia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Uterine Myoma focused on measuring Myomectomy, Laparoscopic myomectomy, Morcellation, Risk of dissemination, Uterine Sarcoma, Parasitic myoma

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Chair of Obstetrics and Gynecology - University division - UMG

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Extracorporeal morcellation

Intracorporeal morcellation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Operative time
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
from skin incision to skin closure
Handling of morcellation
expressed on the VAS scale where 1 means very bad handling and 10 excellent handling
Blood loss
Blood loss will be calculated by the difference of Hb level 2 hours after surgery and the morning of the surgery
Postoperative hospital stay
Postoperative pain
measured on the VAS scale where 1 stands for a little pain and 10 for intense pain
Rate of complications
need of transfusion or laparotomic conversion

Full Information

First Posted
March 9, 2014
Last Updated
April 19, 2015
Sponsor
University Magna Graecia
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1. Study Identification

Unique Protocol Identification Number
NCT02086435
Brief Title
Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes
Acronym
IEME
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Magna Graecia

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Myoma
Keywords
Myomectomy, Laparoscopic myomectomy, Morcellation, Risk of dissemination, Uterine Sarcoma, Parasitic myoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extracorporeal morcellation
Arm Type
Experimental
Arm Description
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
Arm Title
Intracorporeal morcellation
Arm Type
Active Comparator
Arm Description
Intracorporeal morcellation patients treated with standard intracorporeal morcellation, using reusable electronic device
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal morcellation
Other Intervention Name(s)
protected morcellation, morcellation in endobag
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Intracorporeal morcellation
Other Intervention Name(s)
Power morcellation, Standard intracorporeal morcellation
Intervention Description
patients treated with standard intracorporeal morcellation, using reusable electronic device
Primary Outcome Measure Information:
Title
Operative time
Description
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
Time Frame
The day of surgery
Secondary Outcome Measure Information:
Title
Total operative time
Description
from skin incision to skin closure
Time Frame
The day of surgery
Title
Handling of morcellation
Description
expressed on the VAS scale where 1 means very bad handling and 10 excellent handling
Time Frame
The day of surgery
Title
Blood loss
Description
Blood loss will be calculated by the difference of Hb level 2 hours after surgery and the morning of the surgery
Time Frame
2 hours after the end of surgery
Title
Postoperative hospital stay
Time Frame
The day of patient discharge, average 4 day after surgery
Title
Postoperative pain
Description
measured on the VAS scale where 1 stands for a little pain and 10 for intense pain
Time Frame
The day of patient discharge, average 4 day after surgery
Title
Rate of complications
Description
need of transfusion or laparotomic conversion
Time Frame
The day of patient discharge, average 4 day after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fulvio Zullo
Organizational Affiliation
Magna Graecia University of Catanzaro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chair of Obstetrics and Gynecology - University division - UMG
City
Catanzaro
State/Province
CZ
ZIP/Postal Code
88100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
26801067
Citation
Venturella R, Rocca ML, Lico D, La Ferrera N, Cirillo R, Gizzo S, Morelli M, Zupi E, Zullo F. In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial. Fertil Steril. 2016 May;105(5):1369-1376. doi: 10.1016/j.fertnstert.2015.12.133. Epub 2016 Jan 19.
Results Reference
derived

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Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes

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