Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes

Study Overview
=================
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.

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

Conditions
-----------------
Uterine Myoma

Intervention / Treatment
-----------------
* Procedure: Extracorporeal morcellation
* Procedure: Intracorporeal morcellation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extracorporeal morcellation<br>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<br>* 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<br>* Other names: morcellation in endobag;|
| Active Comparator: Intracorporeal morcellation<br>Intracorporeal morcellation patients treated with standard intracorporeal morcellation, using reusable electronic device | Procedure: Intracorporeal morcellation<br>* patients treated with standard intracorporeal morcellation, using reusable electronic device<br>* Other names: 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic myomectomy, Myomectomy, Morcellation, Risk of dissemination, Uterine Sarcoma, Parasitic myoma