Uterine Myoma
Conditions
Keywords
Myomectomy, Laparoscopic myomectomy, Morcellation, Risk of dissemination, Uterine Sarcoma, Parasitic myoma
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.
Interventions
PROCEDUREExtracorporeal 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
PROCEDUREIntracorporeal morcellation
patients treated with standard intracorporeal morcellation, using reusable electronic device
Sponsors
University Magna Graecia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Total operative time | The day of surgery | from skin incision to skin closure |
| 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 |
| Rate of complications | The day of patient discharge, average 4 day after surgery | need of transfusion or laparotomic conversion |
| Postoperative hospital stay | The day of patient discharge, average 4 day after surgery | — |
Countries
Italy
Outcome results
None listed