BACKGROUND: ginecologica esiti di chirurgia laparoscopica può essere compromessa dalla formazione di aderenze de novo. Questo studio randomizzato in doppio cieco è stato progettato per valutare l'efficacia e la sicurezza della soluzione di icodestrina 4% (Adept (®)) nella riduzione del de novo incidenza adesione rispetto alla soluzione di Ringer lattato (LRS).
METODI: I pazienti sottoposti a chirurgia laparoscopica per la rimozione dei miomi o cisti endometriosiche sono stati trattati con una soluzione randomizzato come irrigante intra-operatoria e 1l instillate post-operatorio. Incidenza adesione De novo (numero di siti con aderenze), la gravità e la portata sono stati segnati in maniera indipendente a una procedura secondo-look e l'efficacia delle due soluzioni a confronto. È stato anche studiato l'effetto di covariate chirurgiche su formazione di aderenze. Analisi esplorativa iniziale dei singoli siti anatomici di importanza clinica è progredito. RISULTATI Dei 498 pazienti randomizzati, 330 sono stati valutati (160 LRS - 75% miomectomia / 25% cisti endometriosiche, 170 Adept - 79% miomectomia / 21% cisti endometriosiche). Al completamento dello studio, il 76,2% e il 77,6% LRS Adept aveva ≥ 1 de novo adesione. La media (SD) numero di de novo aderenze was 2.58 (2.11) per Adept e 2,58 (2,38) per LRS. La differenza di effetto del trattamento non è stata significativa (P = 0,909). Valutazione della covariate chirurgici identificati influenze significative sul numero medio di de novo adesioni indipendentemente dal trattamento, compresa la durata dell'intervento (P = 0,048), la perdita di sangue nei pazienti miomectomia (P = 0,019), la lunghezza di incisione uterina in pazienti miomectomia (P <0,001 ) e il numero di nodi di sutura (P <0.001). Ci sono stati 15 eventi avversi considerati correlati al trattamento nei pazienti LRS (7,2%) e 18 nel gruppo Adept (8,3%). Di 17 riportati eventi avversi gravi (9 LRS; 8 Adept) nessuno è stato considerato correlato al trattamento.
CONCLUSIONI: Lo studio ha confermato la sicurezza di Adept in chirurgia laparoscopica. La proporzione di pazienti con de novo formazione di aderenze era notevolmente superiore a quello della letteratura precedente suggerito. Nel complesso non vi era alcuna evidenza di un effetto clinico, ma varie covariate chirurgiche compresa la durata dell'intervento, la perdita di sangue, il numero e la dimensione delle incisioni, sutura e il numero di nodi sono stati trovati per influenzare de novo formazione di aderenze. Lo studio fornisce indicazioni per la futura ricerca nelle strategie di riduzione di adesione in chirurgia site specific.
OBJECTIVE: To assess the safety and efficacy of Sepraspray Adhesion Barrier (a modified hyaluronic acid and carboxymethylcellulose powder) after laparoscopic surgery, in view of both the high efficacy of Seprafilm Adhesion Barrier in reducing postoperative adhesions after open surgical procedures and the difficulty with laparoscopic delivery.
DESIGN: Multicenter, randomized, reviewer-blinded trial.
SETTING: Reproductive endocrinology and infertility clinics.
PATIENT(S): Women undergoing laparoscopic myomectomy for indications including infertility.
INTERVENTION(S): Randomization to treatment with (n = 21) or without (n = 20) Sepraspray Adhesion Barrier.
MAIN OUTCOME MEASURE(S): Postoperative adhesions development was assessed at early second-look laparoscopy. Adhesions were scored using the modified American Fertility Society scoring system.
RESULT(S): Surgical procedure duration length was 99 versus 102 minutes in the control versus Sepraspray Adhesion Barrier groups, respectively, with the median number of fibroids removed being two in each group and corresponding fibroid weights of 134 ± 103 versus 113 ± 161 g, respectively. Adhesions scores increased in both the control and Sepraspray Adhesion Barrier groups, with larger although nonstatistically significant increases noted in control subjects when evaluating for the anterior uterus, the posterior uterus, and the entire uterus.
CONCLUSION(S): Laparoscopic application of Sepraspray Adhesion Barrier after myomectomy in this pilot study was associated with a trend toward a reduction in postoperative adhesion development, as well as an encouraging safety profile. Further evaluation is warranted.
CLINICAL TRIAL NUMBER: Sepraspray Adhesion Barrier #NCT00624930.
BACKGROUND: This multicenter, randomized, single-blind study assessed the safety and efficacy of a resorbable hydrogel ('Hydrogel') for the reduction of post-operative adhesion formation following myomectomy.
METHODS: Women (n = 71) who were undergoing laparoscopic (67.6%) or laparotomic myomectomy were randomized (2:1) to Hydrogel (sprayed over surgically treated areas prior to wound closure, n = 48) or to control (standard care, n = 23). Patients (38 Hydrogel, 20 control) returned 8-10 weeks later for a second look. Adhesions were graded using a modified American Fertility Society (mAFS) scoring method. The primary efficacy measure was the posterior uterus mAFS score.
RESULTS: For Hydrogel and control patients, respectively, mean +/- SD mAFS scores were 0.5 +/- 1.4 and 0.0 +/- 0.0 at baseline, and 1.1 +/- 1.9 and 2.6 +/- 2.2 at the second look. Similarly, mean changes from baseline were 0.8 +/- 2.0 and 2.6 +/- 2.2 (P = 0.01); 95% confidence intervals for these mean changes were (0.16-1.44) and (1.64-3.56). Adverse events were reported by 9.6 and 17.4% of Hydrogel and control patients, respectively. No intra-abdominal infections or post-operative site infections were reported.
CONCLUSIONS: This 71-patient study provides the first clinical evidence of the safety and efficacy of Hydrogel for the reduction of adhesions following myomectomy. The ClinicalTrials.gov Identifier is NCT00562471.
OBJECTIVE: To correlate parameters of endometriosis obtained during routine clinical evaluation with the subsequent formation of adhesions following surgical treatment by laparoscopy.
DESIGN: Randomized, controlled, double-blind, clinical trial.
SETTING: Tertiary referral centers for the treatment of endometriosis.
PATIENT(S): Thirty-seven patients (65 with adnexa) with stage I-III endometriosis; endometrioma-only patients were excluded.
INTERVENTION: Laparoscopic surgical treatment of endometriosis, followed by randomization to Oxiplex/AP (FzioMed, Inc., San Luis Obispo, California) gel treatment (treated group) of adnexa, or surgery alone (control group); follow-up laparoscopy 6-10 weeks later.
MAIN OUTCOME MEASURE(S): Adnexal Americn Fertility Society score, correlated with color and location of endometriosis, as well as stage of disease determined by masked review of videotapes.
RESULT(S): Control patients with at least 50% red lesions had a greater increase in ipsilateral adnexal adhesion scores than patients with mostly black or white and/or clear lesions. Treated patients with red lesions had a greater decrease in adnexal adhesion scores than control patients. There was a correlation between baseline endometriosis stage and postoperative adhesion formation in control patients, but not treated patients.
CONCLUSION(S): Patients with red endometriotic lesions had greater increases in their adhesion scores than patients with only black, white, and/or clear lesions. Oxiplex/AP gel was effective in reducing adhesions, compared to surgery alone, in all groups.
OBIETTIVO: Per valutare l'efficacia e la sicurezza di Adept (soluzione icodestrina 4%) nel ridurre aderenze dopo chirurgia ginecologica laparoscopica coinvolgono adesiolisi.
DESIGN: Multicenter, prospettico, randomizzato, in doppio cieco confrontando Adept con la soluzione di Ringer lattato (LRS).
PAZIENTE (S): Quattrocento due pazienti randomizzati durante l'intervento di Adept (n = 203) o LRS (n = 199) è tornato per la seconda laparoscopia entro 4-8 settimane. Incidenza, la gravità, e l'estensione delle aderenze sono stati determinati in entrambe le occasioni.
OUTCOME MAIN MISURA (S): La misura di efficacia primaria definita dalla Food and Drug Administration è stato il numero di pazienti che hanno raggiunto il successo clinico con il trattamento adesione. Altre misure comprese incidenza e American Fertility Society (AFS) segna.
Risultato (i): significativamente i pazienti più abili raggiunto il successo clinico rispetto ai pazienti LRS (49% vs. 38%). Nei pazienti infertilità, Adept dimostrato particolare successo clinico rispetto a LRS (55% vs 33%). Questo si è riflesso nel numero di pazienti con un punteggio AFS ridotta (53% vs. 30%) e in minor numero di pazienti con grave categoria punteggio moderata / AFS (43% vs. 14%). Sicurezza era paragonabile in entrambi i gruppi. La maggior parte degli eventi sono stati legati alla chirurgia, con un aumento transitorio edema labiale nel gruppo Adept.
CONCLUSIONE (S): Questo è il primo studio randomizzato, in doppio cieco di un agente di riduzione di adesione. È dimostrato che Adept è un agente di riduzione adesione sicuro ed efficace in laparoscopia.
BACKGROUND: Following myomectomy, postoperative adhesions occur in many patients with adverse effects on fertility. This study investigated the applicability, safety and efficacy of an auto-crosslinked hyaluronan gel in preventing adhesion formation after laparoscopic myomectomy.
METHODS: Fifty-two patients aged 22-42 years, undergoing surgery at four centres, were randomly allocated to receive either the gel or no adhesion prevention. The incidence and severity of postoperative adhesions were assessed laparoscopically after 12-14 weeks in a blinded, scored fashion. The primary efficacy variable was the presence/absence of postoperative adhesions at second-look.
RESULTS: A nonsignificantly higher proportion of patients receiving the gel were free from adhesions (13 of 21; 62%) compared with control patients (9 of 22; 41%), with a statistically significant difference between the severity of uterine adhesions at baseline and at second-look (0.3 +/- 0.9 versus 0.8 +/- 1.0, P < 0.05). In subjects undergoing myomectomy without concomitant surgery, the proportion of adhesion-free patients was 8 of 12 (67%) and 4 of 11 (36%) (not significant) in the gel and control groups, respectively, with a significant difference in the mean severity scores (P < 0.05). In subjects without uterine adhesions before myomectomy, 12 of 18 (67%) and 8 of 20 (40%) patients in the gel and control groups, respectively were adhesion-free (not significant), with a significant difference in the severity of uterine adhesions (P = 0.05).
CONCLUSIONS: Our results suggest that the auto-crosslinked hyaluronan gel may have a favourable safety profile and efficacious antiadhesive action following laparoscopic myomectomy.
BACKGROUND: Commonly used adhesion prevention devices either cannot be applied or are difficult to use via laparoscopy. A viscoelastic gel was developed specifically for adhesion prophylaxis during minimally invasive surgery.
METHODS: Randomized, third party-blinded, parallel-group design conducted at four centres. Patients (18-46 years old) underwent laparoscopic surgery with second look 6-10 weeks later. Viscoelastic gel coated adnexa and adjacent tissues. Blinded reviews of videotapes were quantified by American Fertility Society (AFS) adhesion scores.
RESULTS: In 25 treatment patients, surgery was performed on 45 adnexa. Coverage of surgical sites at risk for adhesions was typically accomplished with approximately 15 ml of viscoelastic gel which was delivered in approximately 90 s. In 24 control patients, surgery alone was performed on 41 adnexa. Treated adnexa showed a decrease in AFS score (11.9-9.1). In contrast, control adnexa showed an increase in AFS score (8.8-15.8). This difference in second-look AFS scores (42% reduction) is significant (P<0.01). Ninety-three per cent of treated adnexa did not have a worse adhesion score in contrast to 56% of control adnexa. Combining scores into prognostic categories also show significant treatment effect of the viscoelastic gel (P<0.01).
CONCLUSION: Viscoelastic gel was easy to use via laparoscopy and produced significant reduction in adnexal adhesions. It provides benefits to patients undergoing gynaecological surgery.
