Clinical trial NCT02086435: Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes
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
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Myoma
Keywords: Myomectomy
Laparoscopic myomectomy
Morcellation
Risk of dissemination
Uterine Sarcoma
Parasitic myoma
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Operative time
timeFrame: The day of surgery
Secondary outcomes:
measure: Total operative time
timeFrame: The day of surgery
measure: Handling of morcellation
timeFrame: The day of surgery
measure: Blood loss
timeFrame: 2 hours after the end of surgery
measure: Postoperative hospital stay
timeFrame: The day of patient discharge, average 4 day after surgery
measure: Postoperative pain
timeFrame: The day of patient discharge, average 4 day after surgery
measure: Rate of complications
timeFrame: The day of patient discharge, average 4 day after surgery
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Chair of Obstetrics and Gynecology - University division - UMG
state: CZ
Study officials:
affiliation: Magna Graecia University of Catanzaro
name: Fulvio Zullo
role: PRINCIPAL_INVESTIGATOR
References:
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.