Dipartimento Materno-Infantile

Direttore : Paolo Puggina

Miomectomia laparoscopica indicazioni e limiti

Giuseppe De Francesco

“The clinical dilemma is whether we treat all symptomatic uterine leiomyomas

as cancer until proved otherwise”.

� Abandonment of morcellation (zero reduction)

� Patient triage (probable risk reduction)

� In bag morcellation ( unproven safety)

2015

Suzanne George, MD, Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston

;

Cancer October 15, 2014

”… Whether electromechanical morcellation poses a unique danger to the patient with occult leiomyosarcoma is an unanswered question..”

Morcellation During Uterine Tissue

Extraction

Nezhat C. President of AAGL,2014

Morcellation During Uterine Tissue

Extraction

Nezhat C. President of AAGL,2014

Conclusion

It is the opinion of the AAGL that all existing methods of tissue extraction

have benefits and risks, which must be balanced. At this time, we do not

believe there is a single method that can protect all patients; therefore, all

current methods of tissue extraction should remain available. We believe

that an understanding of the issues reviewed in this document will allow

surgeons and hospitals to make the most appropriate, informed choices

regarding utilization of tissue extraction in individual patients undergoing

uterine surgery. C

MEMBER UPDATE #5:AAGL Response to FDA Guidance on Use of Power Morcellation during

Tissue Extraction for Uterine Fibroid

November 25, 2014

In summary, abandoning power morcellation technology for many patients undergoing minimally invasive myomectomy,

supracervical hysterectomy, or hysterectomy for a large uterus will be a setback in the care of patients with gynecologic

conditions.

With meticulous adherence to preoperative patient selection guidelines and informed consent, the AAGL believes appropriately performed power morcellation outweighs the risk of laparotomy in low-risk patients and is an option to be carefully considered by patients and their gynecologists."

CuldotomyVaginal outlet

CuldotomyVaginal outlet

2010

ObjectivesTo determine the efficacy and safety of the removal of uterine fibroids in subfertile women by laparotomy,laparoscopy or hysteroscopy when compared with expectant management or each other. The review will includealso new surgical approaches as and when they are trialed.

Authors’ conclusionsThere is limited evidence to suggest that there is no difference in fertility efficacy outcome if fibroids are removedvia laparotomy when compared to laparoscopy. There is no good randomised controlled evidence to supporthysteroscopic removal of fibroids compared to other surgical modalities for fertility efficacy.

Surgical treatment of fibroids for subfertility (Re view)Griffiths AN, D’Angelo A, Amso NN

2012

Surgical treatment of fibroids for subfertility (Review)

Metwally M, Cheong YC, Horne AW

ObjectivesTo examine the effect of myomectomy on fertility outcomes and to compare different surgical approaches

Authors’ conclusionsThere is currently insufficient evidence from randomised controlled trials to evaluate the role ofmyomectomy to improve fertility.Regarding the surgical approach to myomectomy…there is no significant difference between thelaparoscopic and open approach regarding fertility performance. .

2014

ObjectivesTo determine the benefits and harms of laparoscopic or hysteroscopic myomectomy compared with open myomectomy

Authors’ conclusionsLaparoscopic myomectomy is a procedure associated with less subjectively reported postoperative pain, lowerpostoperative fever and shorter hospital stay compared with all types of open myomectomy.No evidence suggested a difference in recurrence risk between laparoscopic and open myomectomy. More

studies are needed to assess rates of uterine rupture, occurrence of thromboembolism, need for repeatmyomectomy and hysterectomy at a later stage.

� “ The mechanisms by which myomas may adversely affect fertility are several:

• Displacement of the cervix that may reduce exposure to sperm

• Enlargement or deformity of the uterine cavity that may interfere with spermmigration and transport

• Obstruction of the proximal fallopian tubes

• Altered tubo-ovarian anatomy, interfering with ovum capture

• Increased or disordered uterine contractility that may hinder sperm or embryotransport or nidation

• Distortion or disruption of the endometrium and implantation due to atrophyor venous ectasia over or opposite a submucous myoma

• Impaired endometrial blood flow

• Endometrial inflammation or secretion of vasoactive substances

Fertil Steril, 2008 American Society for Reproductive Medicine

«….In relazione all’aumentato rischio assoluto di rottura d’utero, la possibilità di un parto vaginale dopo taglio cesareo è controindicata in caso di pregressa rottura d’utero, pregressa incisione uterina longitudinale e in caso di tre o più tagli cesarei precedenti……» (BPC)

“….There is insufficient and conflicting information on whether the risk of uterine rupture is increased in women with previous myomectomy…”

The log rank test was usedcomparing the pregnancyrate in two groups:no significantdifferences were found

2014

2010 AAGL

� “ Since nearly complete suturing is possible in LaparoscopicMyomectomy (LM) as in laparotomy, vaginal delivery can beaccomplished safely without uterine rupture even after LM(VBALM), provided that delivery is managed as in vaginalbirth after cesarean section (VBAC)”.

2005 AAGL

� Conclusion “ With the widespread adoption of LM as conservative surgery for uterine myoma, the number of patients desiring to become pregnant and deliver vaginally after LM is likely to increase. The results of the current study suggest that the risk of uterine rupture in pregnancy or delivery subsequent to LM is extremely low if the myomectomy wounds are sutured appropriately during the LM, and that a vaginal birth under strict delivery management can be safely chosen for selected patients after LM”.

2008 AAGL

Pregnancy and fertility rate after LM

To confirm the validity of the Laparoscopic

approach: quality of the uterine scar

Delivery outcome: vaginal delivery or cesarean

section?

Fertility, obstetric and delivery outcome after laparoscopic myomectomy in the patient

with“unexplained” infertility

� Setting: Evangelical Hospital of Naples - “Villa Betania”- Department of

Obstetrics and Gynaecology

� January 2002 - December 2014

� Patient(s): 168 women with diagnosis of unexplained infertility and presumed

uterine myoma

� Intervention(s): Laparoscopic Myomectomy. In our study, myomectomy was

performed exclusively by laparoscopy. LM, as well as other laparoscopic

procedures, has less morbidity, rapid recovery, and potentially less risk for

adhesion formation

Patients characteristics

LaparoscopicMyomectomy

N° of patients (%) 168Age (years) 30+/-6,2Parity 0Infertility period (months) 24+/-7

�Indication for myomectomy (n)

Unexplained infertility 168

�Uterine and leiomyoma characteristics

Leiomyoma diameter (cm) 6,5 (3,5-10)Number of leiomyomas 1,5 (1-3)

�Localization of leiomyomas (n)

Intramural 168

LaparoscopicMyomectomy

Waiting Period after LM (mounth) 8 (6-10)

Pregnancy rate (%) 82 (48,8%)

Abortion rate (%) 23 (28%)

Pregnancy in progress 4

Ectopic pregnancy 2

Deliveries 59 (71.9%)

Preterm deliveries (%) 2 (3,38%)

Vaginal birth (%) 41 (69,49%)

Caesarean section (%) 16 (27,1%)

Uterine rupture 0

Ulipristal Acetate for Fibroid Treatment before Surgery

UPA optimizes operative conditions and thus the postoperative outcome by:

� Control of uterine bleeding (reducing anemia )� Down-sizing of fibroids� Post-operative treatment of recurrent� In cases of large fibroids, UPA administration can probably

avoid hysterectomy and laparotomy in favour of laparoscopic or hysteroscopic enucleation of fibroids