Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes

Uterine Myoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086435
• Other study ID #: SafeMorcellation
• Status: Completed
• Phase: N/A
• First received: March 9, 2014
• Last updated: April 19, 2015
• Start date: March 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Myoma

Intervention

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

Locations

Country	Name	City	State
Italy	Chair of Obstetrics and Gynecology - University division - UMG	Catanzaro	CZ

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Total operative time	from skin incision to skin closure	The day of surgery	Yes
Secondary	Handling of morcellation	expressed on the VAS scale where 1 means very bad handling and 10 excellent handling	The day of surgery	No
Secondary	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	Yes
Secondary	Postoperative hospital stay		The day of patient discharge, average 4 day after surgery	Yes
Secondary	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	Yes
Secondary	Rate of complications	need of transfusion or laparotomic conversion	The day of patient discharge, average 4 day after surgery	Yes