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

A Randomized Controlled Trial on Intracorporeal Versus Extracorporeal Morcellation With Endobag Extraction in Patients Undergoing Laparoscopic Myomectomy: Clinical Efficacy and Safety Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Uterine Myoma
• Intervention / Treatment: Procedure: Extracorporeal morcellation; Procedure: Intracorporeal morcellation

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • CZ
    • Catanzaro, CZ, Italy, 88100
      • Chair of Obstetrics and Gynecology - University division - UMG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total operative time	from skin incision to skin closure	The day of surgery
Handling of morcellation	expressed on the VAS scale where 1 means very bad handling and 10 excellent handling	The day of surgery
Blood loss	Blood loss will be calculated by the difference of Hb level 2 hours after surgery and the morning of the surgery	2 hours after the end of surgery
Postoperative hospital stay		The day of patient discharge, average 4 day after surgery
Postoperative pain	measured on the VAS scale where 1 stands for a little pain and 10 for intense pain	The day of patient discharge, average 4 day after surgery
Rate of complications	need of transfusion or laparotomic conversion	The day of patient discharge, average 4 day after surgery

Collaborators and Investigators

• Sponsor: University Magna Graecia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: March 9, 2014
• First Submitted That Met QC Criteria: March 12, 2014
• First Posted (ESTIMATE): March 13, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): April 21, 2015
• Last Update Submitted That Met QC Criteria: April 19, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Myomectomy; Morcellation; Laparoscopic myomectomy; Risk of dissemination; Uterine Sarcoma; Parasitic myoma
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: SafeMorcellation