BACKGROUND: Fibroids are the most common benign tumours of the female genital tract and are associated with numerous clinical problems including a possible negative impact on fertility. In women requesting preservation of fertility, fibroids can be surgically removed (myomectomy) by laparotomy, laparoscopically or hysteroscopically depending on the size, site and type of fibroid. Myomectomy is however a procedure that is not without risk and can result in serious complications. It is therefore essential to determine whether such a procedure can result in an improvement in fertility and, if so, to then determine the ideal surgical approach.
OBJECTIVES: To examine the effect of myomectomy on fertility outcomes and to compare different surgical approaches.
SEARCH METHODS: We searched the Cochrane Gynaecology and Fertility Group (CGFG) Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, Epistemonikos database, World Health Organization (WHO) International Clinical Trials Registry Platform search portal, Database of Abstracts of Reviews of Effects (DARE), LILACS, conference abstracts on the ISI Web of Knowledge, OpenSigle for grey literature from Europe, and reference list of relevant papers. The final search was in February 2019.
SELECTION CRITERIA: Randomised controlled trials (RCTs) examining the effect of myomectomy compared to no intervention or where different surgical approaches are compared regarding the effect on fertility outcomes in a group of infertile women suffering from uterine fibroids.
DATA COLLECTION AND ANALYSIS: Data collection and analysis were conducted in accordance with the procedure suggested in the Cochrane Handbook for Systematic Reviews of Interventions.
MAIN RESULTS: This review included four RCTs with 442 participants. The evidence was very low-quality with the main limitations being due to serious imprecision, inconsistency and indirectness. Myomectomy versus no intervention One study examined the effect of myomectomy compared to no intervention on reproductive outcomes. We are uncertain whether myomectomy improves clinical pregnancy rate for intramural (odds ratio (OR) 1.88, 95% confidence interval (CI) 0.57 to 6.14; 45 participants; one study; very low-quality evidence), submucous (OR 2.04, 95% CI 0.62 to 6.66; 52 participants; one study; very low-quality evidence), intramural/subserous (OR 2.00, 95% CI 0.40 to 10.09; 31 participants; one study; very low-quality evidence) or intramural/submucous fibroids (OR 3.24, 95% CI 0.72 to 14.57; 42 participants; one study; very low-quality evidence). Similarly, we are uncertain whether myomectomy reduces miscarriage rate for intramural fibroids (OR 1.33, 95% CI 0.26 to 6.78; 45 participants; one study; very low-quality evidence), submucous fibroids (OR 1.27, 95% CI 0.27 to 5.97; 52 participants; one study; very low-quality evidence), intramural/subserous fibroids (OR 0.80, 95% CI 0.10 to 6.54; 31 participants; one study; very low-quality evidence) or intramural/submucous fibroids (OR 2.00, 95% CI 0.32 to 12.33; 42 participants; one study; very low-quality evidence). This study did not report on live birth, preterm delivery, ongoing pregnancy or caesarean section rate. Laparoscopic myomectomy versus myomectomy by laparotomy or mini-laparotomy Two studies compared laparoscopic myomectomy to myomectomy at laparotomy or mini-laparotomy. We are uncertain whether laparoscopic myomectomy compared to laparotomy or mini-laparotomy improves live birth rate (OR 0.80, 95% CI 0.42 to 1.50; 177 participants; two studies; I2 = 0%; very low-quality evidence), preterm delivery rate (OR 0.70, 95% CI 0.11 to 4.29; participants = 177; two studies; I2 = 0%, very low-quality evidence), clinical pregnancy rate (OR 0.96, 95% CI 0.52 to 1.78; 177 participants; two studies; I2 = 0%, very low-quality evidence), ongoing pregnancy rate (OR 1.61, 95% CI 0.26 to 10.04; 115 participants; one study; very low-quality evidence), miscarriage rate (OR 1.25, 95% CI 0.40 to 3.89; participants = 177; two studies; I2 = 0%, very low-quality evidence), or caesarean section rate (OR 0.69, 95% CI 0.34 to 1.39; participants = 177; two studies; I2 = 21%, very low-quality evidence). Monopolar resectoscope versus bipolar resectoscope One study evaluated the use of two electrosurgical systems during hysteroscopic myomectomy. We are uncertain whether bipolar resectoscope use compared to monopolar resectoscope use improves live birth/ongoing pregnancy rate (OR 0.86, 95% CI 0.30 to 2.50; 68 participants; one study, very low-quality evidence), clinical pregnancy rate (OR 0.88, 95% CI 0.33 to 2.36; 68 participants; one study; very low-quality evidence), or miscarriage rate (OR 1.00, 95% CI 0.19 to 5.34; participants = 68; one study; very low-quality evidence). This study did not report on preterm delivery or caesarean section rate.
AUTHORS' CONCLUSIONS: There is limited evidence to determine the role of myomectomy for infertility in women with fibroids as only one trial compared myomectomy with no myomectomy. If the decision is made to have a myomectomy, the current evidence does not indicate a superior method (laparoscopy, laparotomy or different electrosurgical systems) to improve rates of live birth, preterm delivery, clinical pregnancy, ongoing pregnancy, miscarriage, or caesarean section. Furthermore, the existing evidence needs to be viewed with caution due to the small number of events, minimal number of studies and very low-quality evidence.
BACKGROUND: Myomectomy has potential risks of complications. To reduce these risks, medical pre-treatment can be applied to reduce fibroid size and thereby potentially decrease intra-operative blood loss, the need for blood transfusion and emergency hysterectomy. The aim of this systematic review and meta-analysis is to study the effectiveness of medical pre-treatment with Gonadotropin-releasing hormone agonists (GnRHa) or ulipristal acetate prior to laparoscopic or laparotomic myomectomy on intra-operative and post-operative outcomes.
METHODS: We performed an extensive search in Embase.com, Wiley/Cochrane Library and PubMed in accordance with the Prisma guidelines. All studies published as full papers in peer reviewed journals using GnRHa or ulipristal acetate as medical pre-treatment independent of route of administration or dosage before laparotomic or laparoscopic myomectomy were included. The primary outcome was duration of surgery. Secondary outcomes were duration of enucleation, blood loss, degree of difficulty of surgery, identification of cleavage planes, proportion of vertical incisions, conversion rate, frequency of blood transfusions, post-operative complications, duration of hospital stay, frequency of recurrence of fibroids, frequency of uterine adhesions, recovery time and quality of life. No language restrictions were applied. Meta-analysis were performed where possible.
FINDINGS: Twenty-three studies were included. In laparotomic myomectomy, pre-treatment with GnRHa decreases intra-operative blood loss with 97.39ml (95% CI -111.80 to -82.97) compared to no pre-treatment or placebo. Pre-treatment with GnRHa before laparoscopic myomectomies also shows a reduction in intra-operative blood loss by 23.03ml (95% CI -40.79 to -5.27) and in the frequency of blood transfusions (OR 0.17, 95% CI 0.05 to 0.55) compared to no pre-treatment. Only two retrospective cohort studies reported on pre-treatment with ulipristal acetate compared to no pre-treatment before laparoscopic myomectomy showing a statistically significant reduction in intra-operative blood loss, duration of surgery and frequency of blood transfusions after pre-treatment with ulipristal acetate.
CONCLUSION: Administration of GnRHa prior to laparotomic myomectomy reduces blood loss and might decrease uterine adhesion formation. Pre-treatment with GnRHa before laparoscopic myomectomy reduces blood loss, the frequency of blood transfusions and might increase recurrence rate of fibroids, however it should be taken into account that some results are mainly based on cohort studies. Other pre-treatment agent ulipristal acetate has not been investigated sufficiently for relevant surgical outcomes.
BACKGROUND: I fibromi sono tumori benigni comuni derivanti in utero. Miomectomia è il trattamento chirurgico di scelta per le donne con fibromi sintomatici che preferiscono o vogliono la conservazione dell'utero. Miomectomia può essere eseguita da laparotomia convenzionale, in mini-laparotomia o mediante tecniche minime di accesso come isteroscopia e laparoscopia.
OBIETTIVI: Per determinare i benefici ei rischi di miomectomia laparoscopica o isteroscopica rispetto a miomectomia aperta.
METODI DI RICERCA: Abbiamo cercato il Cochrane Central Register of Controlled Trials (CENTRAL) (inizio a luglio 2014), i disturbi mestruali e Subfertility Group (MDSG) specialistica Registro di Controlled Trials (inizio a luglio 2014), MEDLINE (R) (inizio a luglio 2014), EMBASE (inizio a luglio 2014), PsycINFO (inizio a luglio 2014) e l'indice cumulativo di Infermieristica e Allied Health Letteratura (CINAHL) (inizio a luglio 2014) per identificare i trials randomizzati controllati (RCT). Abbiamo cercato anche i registri di prova e riferimenti da studi pertinenti selezionati e articoli di revisione. Abbiamo applicato nessuna restrizione lingua in queste ricerche.
CRITERI DI SELEZIONE: Tutti pubblicati e non pubblicati studi controllati randomizzati di confronto miomectomia via laparotomia, mini-laparotomia o laparoscopia assistita mini-laparotomia contro laparoscopia o isteroscopia in donne in premenopausa con fibromi uterini diagnosticati mediante esame clinico ed ecografia sono stati inclusi nella meta-analisi.
RACCOLTA DATI E ANALISI: Abbiamo condotto la selezione degli studi e dei dati estratti in duplicato. Outcome primari erano dolore postoperatorio, riportati in sei studi, e in ospedale eventi avversi, segnalati in otto studi. Gli esiti secondari includevano durata della degenza ospedaliera, riportati in quattro studi, tempo di funzionamento, riportati in otto studi e ricorrenza di fibromi, riportati in tre studi. Ogni altra secondaria risultati a miglioramento dei sintomi mestruali, cambiamento nella qualità della vita, ripetere miomectomia e l'isterectomia in una data-è stato segnalato in un singolo studio. Odds ratio (OR), le differenze medie (MDS) e il 95% intervallo di confidenza (IC) sono stati calcolati e dati combinati utilizzando il modello a effetti fissi. La qualità delle prove è stata valutata utilizzando i gradi di valutazione (grado) metodi di raccomandazione, Assessment, Development e.
PRINCIPALI RISULTATI: Abbiamo trovato 23 studi potenzialmente rilevanti, di cui nove sono ammissibili per l'inclusione in questa recensione. I nove studi inclusi nella nostra meta-analisi ha avuto un totale di 808 donne. Il rischio complessivo di parzialità degli studi inclusi è stata bassa, come la maggior parte studi hanno riportato correttamente i loro metodi.
Il dolore postoperatorio: dolore postoperatorio è stato misurato su una scala analogica visiva (VAS), zero significa 'nessun dolore a tutti' e 10 significante 'dolore così male come potrebbe essere.' Il dolore postoperatorio è stato significativamente inferiore, come determinato dal punteggio del dolore soggettivamente valutata in sei ore (MD -2,40, 95% CI -2,88 a -1,92, uno studio, 148 donne, prove di qualità moderata) e 48 ore dopo l'intervento (MD -1,90, 95% CI -2,80 a -1,00, due studi, 80 donne, I² = 0%, prove di qualità moderata) nel gruppo miomectomia laparoscopica rispetto al gruppo miomectomia aperto. Ciò significa che tra le donne sottoposte a miomectomia laparoscopica, media punteggio del dolore a sei ore e 48 ore sarebbero probabilmente variare da circa tre punti in meno di un punto più basso su una scala VAS da zero a 10. Nessuna differenza significativa nel punteggio del dolore postoperatorio è stata osservata tra i gruppi laparoscopiche e miomectomia aperto a 24 ore (MD -0.29, 95% CI -0.7 a 0,12, quattro studi, 232 donne, I² = 43%, la prova di qualità moderata). La qualità complessiva di questi risultati è moderato; quindi ulteriori ricerche potrebbe avere un impatto importante sulla nostra fiducia nella stima dell'effetto e può cambiare la stima.
In ospedale gli eventi avversi: Nessuna prova suggerisce una differenza in programma il ritorno al teatro (OR 3.04, 95% CI 0,12-75,86, due studi, 188 donne, I² = 0%, prove di bassa qualità) e laparoconversion (OR 1.11, 95 % CI 0,44-2,83, otto studi, 756 donne, I² prove = 53%, moderata-qualità) quando miomectomia aperto è stato confrontato con miomectomia laparoscopica. Solo uno studio tra cui 148 donne ha riportato lesioni agli organi pelvici (non ci sono eventi descritti in altri studi), e nessuna differenza significativa è stata osservata tra miomectomia laparoscopica e laparoscopia assistita miomectomia mini-laparotomia (OR 3.04, 95% CI 0,12-75,86). Significativamente più basso rischio di febbre postoperatoria è stato osservato nel gruppo di miomectomia laparoscopica rispetto ai gruppi trattati con tutti i tipi di miomectomia aperta (OR 0,44, 95% CI 0,26-0,77, I² = 0%, sei studi, 635 donne). Ciò indica che tra le donne sottoposte a miomectomia laparoscopica, il rischio di febbre postoperatoria è inferiore del 50% rispetto a quelli trattati con chirurgia a cielo aperto. Nessuno studio riportato isterectomia immediato, rottura uterina, tromboembolia o mortalità. Sei studi, tra cui 549 donne hanno riferito di emoglobina goccia, ma questi studi non sono stati riuniti, data l'estrema eterogeneità (I² = 97%) e, pertanto, non possono essere inclusi nell'analisi.
Conclusioni degli autori: la miomectomia laparoscopica è una procedura associata con meno soggettivamente riferito dolore postoperatorio, la febbre postoperatoria inferiore e degenza ospedaliera più breve rispetto a tutti i tipi di miomectomia aperto. Nessuna prova suggerisce una differenza di rischio di ricorrenza tra laparoscopica e miomectomia aperto. Ulteriori studi sono necessari per valutare i tassi di rottura uterina, comparsa di tromboembolia, la necessità di ripetere miomectomia e l'isterectomia in una fase successiva.
Fibroids are the most common benign tumours of the female genital tract and are associated with numerous clinical problems including a possible negative impact on fertility. In women requesting preservation of fertility, fibroids can be surgically removed (myomectomy) by laparotomy, laparoscopically or hysteroscopically depending on the size, site and type of fibroid. Myomectomy is however a procedure that is not without risk and can result in serious complications. It is therefore essential to determine whether such a procedure can result in an improvement in fertility and, if so, to then determine the ideal surgical approach.
OBJECTIVES:
To examine the effect of myomectomy on fertility outcomes and to compare different surgical approaches.
SEARCH METHODS:
We searched the Cochrane Gynaecology and Fertility Group (CGFG) Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, Epistemonikos database, World Health Organization (WHO) International Clinical Trials Registry Platform search portal, Database of Abstracts of Reviews of Effects (DARE), LILACS, conference abstracts on the ISI Web of Knowledge, OpenSigle for grey literature from Europe, and reference list of relevant papers. The final search was in February 2019.
SELECTION CRITERIA:
Randomised controlled trials (RCTs) examining the effect of myomectomy compared to no intervention or where different surgical approaches are compared regarding the effect on fertility outcomes in a group of infertile women suffering from uterine fibroids.
DATA COLLECTION AND ANALYSIS:
Data collection and analysis were conducted in accordance with the procedure suggested in the Cochrane Handbook for Systematic Reviews of Interventions.
MAIN RESULTS:
This review included four RCTs with 442 participants. The evidence was very low-quality with the main limitations being due to serious imprecision, inconsistency and indirectness. Myomectomy versus no intervention One study examined the effect of myomectomy compared to no intervention on reproductive outcomes. We are uncertain whether myomectomy improves clinical pregnancy rate for intramural (odds ratio (OR) 1.88, 95% confidence interval (CI) 0.57 to 6.14; 45 participants; one study; very low-quality evidence), submucous (OR 2.04, 95% CI 0.62 to 6.66; 52 participants; one study; very low-quality evidence), intramural/subserous (OR 2.00, 95% CI 0.40 to 10.09; 31 participants; one study; very low-quality evidence) or intramural/submucous fibroids (OR 3.24, 95% CI 0.72 to 14.57; 42 participants; one study; very low-quality evidence). Similarly, we are uncertain whether myomectomy reduces miscarriage rate for intramural fibroids (OR 1.33, 95% CI 0.26 to 6.78; 45 participants; one study; very low-quality evidence), submucous fibroids (OR 1.27, 95% CI 0.27 to 5.97; 52 participants; one study; very low-quality evidence), intramural/subserous fibroids (OR 0.80, 95% CI 0.10 to 6.54; 31 participants; one study; very low-quality evidence) or intramural/submucous fibroids (OR 2.00, 95% CI 0.32 to 12.33; 42 participants; one study; very low-quality evidence). This study did not report on live birth, preterm delivery, ongoing pregnancy or caesarean section rate. Laparoscopic myomectomy versus myomectomy by laparotomy or mini-laparotomy Two studies compared laparoscopic myomectomy to myomectomy at laparotomy or mini-laparotomy. We are uncertain whether laparoscopic myomectomy compared to laparotomy or mini-laparotomy improves live birth rate (OR 0.80, 95% CI 0.42 to 1.50; 177 participants; two studies; I2 = 0%; very low-quality evidence), preterm delivery rate (OR 0.70, 95% CI 0.11 to 4.29; participants = 177; two studies; I2 = 0%, very low-quality evidence), clinical pregnancy rate (OR 0.96, 95% CI 0.52 to 1.78; 177 participants; two studies; I2 = 0%, very low-quality evidence), ongoing pregnancy rate (OR 1.61, 95% CI 0.26 to 10.04; 115 participants; one study; very low-quality evidence), miscarriage rate (OR 1.25, 95% CI 0.40 to 3.89; participants = 177; two studies; I2 = 0%, very low-quality evidence), or caesarean section rate (OR 0.69, 95% CI 0.34 to 1.39; participants = 177; two studies; I2 = 21%, very low-quality evidence). Monopolar resectoscope versus bipolar resectoscope One study evaluated the use of two electrosurgical systems during hysteroscopic myomectomy. We are uncertain whether bipolar resectoscope use compared to monopolar resectoscope use improves live birth/ongoing pregnancy rate (OR 0.86, 95% CI 0.30 to 2.50; 68 participants; one study, very low-quality evidence), clinical pregnancy rate (OR 0.88, 95% CI 0.33 to 2.36; 68 participants; one study; very low-quality evidence), or miscarriage rate (OR 1.00, 95% CI 0.19 to 5.34; participants = 68; one study; very low-quality evidence). This study did not report on preterm delivery or caesarean section rate.
AUTHORS' CONCLUSIONS:
There is limited evidence to determine the role of myomectomy for infertility in women with fibroids as only one trial compared myomectomy with no myomectomy. If the decision is made to have a myomectomy, the current evidence does not indicate a superior method (laparoscopy, laparotomy or different electrosurgical systems) to improve rates of live birth, preterm delivery, clinical pregnancy, ongoing pregnancy, miscarriage, or caesarean section. Furthermore, the existing evidence needs to be viewed with caution due to the small number of events, minimal number of studies and very low-quality evidence.
