Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes

Not Applicable

Completed

• Conditions: Uterine Myoma

• Registration Number: NCT02086435
• Lead Sponsor: University Magna Graecia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-09
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-13
• Primary Completion: 2014-12
• Status Verified: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-19
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 93

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Handling of morcellation	The day of surgery	expressed on the VAS scale where 1 means very bad handling and 10 excellent handling
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
Postoperative hospital stay	The day of patient discharge, average 4 day after surgery
Rate of complications	The day of patient discharge, average 4 day after surgery	need of transfusion or laparotomic conversion
Total operative time	The day of surgery	from skin incision to skin closure

Trial Locations

Locations (1)

Chair of Obstetrics and Gynecology - University division - UMG; 🇮🇹 Catanzaro, CZ, Italy