To evaluate the efficacy of presacral neurectomy inaddition to conservative surgical treatment of endometriosis in womenwith severe dysmenorrhea.DESIGN Randomized, double-blind (subject and assessor), controlledtrial. Allocation was computer-generated and blocked.SETTING University hospital in Italy.UnRegisteredSUBJECTS A total of 126 sexually active women of reproductive age(mean 31, range 26–39 years), who had severe midline dysmenorrheaof >6 months duration due to endometriosis and were undergoingconservative laparoscopic surgical treatment. Excluded were womenwith body mass index >30 kg/m2 , a psychiatric disorder, or a historyof pelvic surgery or infection. An additional six randomized womenin each group were excluded after laparoscopy because of the presenceof another gynecological disease or the absence of endometriosis, andthree women were lost to follow-up.INTERVENTION All women underwent laparoscopic excision orelectrocautery of all visible endometriotic lesions. Randomizationallocated 71 women to have presacral neurectomy (treatment group) and70 women to have no further treatment (control group). Uterosacralligament resection was performed in three women in each group.MAIN OUTCOME MEASURES Cure of dysmenorrhea (complete relief or mildpain not requiring medication) at 6 months and 1 year after surgery,frequency and severity of dysmenorrhea, dyspareunia, and pelvic pain.MAIN RESULTS The stages of endometriosis were similarly distributedin the two groups (stage I 27%, stage II 34%, stage III 27%, stageIV 12%). The operation time was 13 minutes longer, on average, in thetreatment group, but there was no significant difference betweengroups in length of hospital stay or short-term complications. At 6months after surgery, constipation was reported by 33% and urinaryurgency by 5% of women in the treatment group, but no complicationwas reported in the control group. The cure rate of dysmenorrhea was87% in the treatment group compared to 60% in the control group at6 months (p<0.001, relative risk (RR) 1.4, 95% CI 1.2–1.8) * and 86and 57%, respectively, at 1 year (p< 0.001, RR 1.5, CI 1.2–1.9, numberneeded to treat to achieve cure in one additional woman is 4, CI 2–8)* . About 17% of women in each group experienced complete relief ofdysmenorrhea. The cure rates in both groups and the benefit ofpresacral neurectomy were similar, regardless of stage ofendometriosis. By intention-to-treat analysis, assuming all excludedwomen had failure of cure, presacral neurectomy was still found toprovide benefit (cure rates at 1 year 76 vs 51%, p=0.002) * . The mean(± SD) dysmenorrhea score (out of 100) was 83 (± 7) at baseline and46 (± 7) at 1 year in the treatment group (p<0.0001) and 83 (± 7)at baseline and 46 (± 7) at 1 year in the control group (p<0.0001)(p<0.0001 treatment vs control). Severity scores of dyspareunia andnonmenstrual pelvic pain were also significantly reduced frombaseline at 1 year in both groups, with significantly greaterreduction in the treatment group. The frequencies of all three typesUnRegisteredof pain were reduced after surgery, but there was no significantdifference between groups.CONCLUSION The addition of presacral neurectomy to conservativelaparoscopic surgery for endometriosis increased the cure rate ofdysmenorrhea at 1 year.

Presacral neurectomy in addition to surgery for endometriosis increased the cure of severe dysmenorrhea

Morelli M;
2004-01-01

Abstract

To evaluate the efficacy of presacral neurectomy inaddition to conservative surgical treatment of endometriosis in womenwith severe dysmenorrhea.DESIGN Randomized, double-blind (subject and assessor), controlledtrial. Allocation was computer-generated and blocked.SETTING University hospital in Italy.UnRegisteredSUBJECTS A total of 126 sexually active women of reproductive age(mean 31, range 26–39 years), who had severe midline dysmenorrheaof >6 months duration due to endometriosis and were undergoingconservative laparoscopic surgical treatment. Excluded were womenwith body mass index >30 kg/m2 , a psychiatric disorder, or a historyof pelvic surgery or infection. An additional six randomized womenin each group were excluded after laparoscopy because of the presenceof another gynecological disease or the absence of endometriosis, andthree women were lost to follow-up.INTERVENTION All women underwent laparoscopic excision orelectrocautery of all visible endometriotic lesions. Randomizationallocated 71 women to have presacral neurectomy (treatment group) and70 women to have no further treatment (control group). Uterosacralligament resection was performed in three women in each group.MAIN OUTCOME MEASURES Cure of dysmenorrhea (complete relief or mildpain not requiring medication) at 6 months and 1 year after surgery,frequency and severity of dysmenorrhea, dyspareunia, and pelvic pain.MAIN RESULTS The stages of endometriosis were similarly distributedin the two groups (stage I 27%, stage II 34%, stage III 27%, stageIV 12%). The operation time was 13 minutes longer, on average, in thetreatment group, but there was no significant difference betweengroups in length of hospital stay or short-term complications. At 6months after surgery, constipation was reported by 33% and urinaryurgency by 5% of women in the treatment group, but no complicationwas reported in the control group. The cure rate of dysmenorrhea was87% in the treatment group compared to 60% in the control group at6 months (p<0.001, relative risk (RR) 1.4, 95% CI 1.2–1.8) * and 86and 57%, respectively, at 1 year (p< 0.001, RR 1.5, CI 1.2–1.9, numberneeded to treat to achieve cure in one additional woman is 4, CI 2–8)* . About 17% of women in each group experienced complete relief ofdysmenorrhea. The cure rates in both groups and the benefit ofpresacral neurectomy were similar, regardless of stage ofendometriosis. By intention-to-treat analysis, assuming all excludedwomen had failure of cure, presacral neurectomy was still found toprovide benefit (cure rates at 1 year 76 vs 51%, p=0.002) * . The mean(± SD) dysmenorrhea score (out of 100) was 83 (± 7) at baseline and46 (± 7) at 1 year in the treatment group (p<0.0001) and 83 (± 7)at baseline and 46 (± 7) at 1 year in the control group (p<0.0001)(p<0.0001 treatment vs control). Severity scores of dyspareunia andnonmenstrual pelvic pain were also significantly reduced frombaseline at 1 year in both groups, with significantly greaterreduction in the treatment group. The frequencies of all three typesUnRegisteredof pain were reduced after surgery, but there was no significantdifference between groups.CONCLUSION The addition of presacral neurectomy to conservativelaparoscopic surgery for endometriosis increased the cure rate ofdysmenorrhea at 1 year.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/20.500.11770/382048
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