Zullo 2003.
Methods | Allocation concealment: unclear. Randomisation: computer‐generated randomisation in single blocks. Blinding: double; participant and investigator blinded throughout the study. Power Calculation: sample size based on assumption that dysmenorrhoea would resolve in 50% controls, 58 women were needed in each group to demonstrate a difference of 25% between control and experimental groups and to define statistical significance between the groups with an alpha of 0.05 and beta of 0.20. Duration of trial: Sept. 1998 to Oct 2001. Follow up: 6 and 12 post operative. | |
Participants | Number of women randomised: 141. Number of women analysed: 126. Drop‐outs/withdrawals: 7 due to the presence of other gynecological diseases, 5 because endometriosis was not confirmed, 3 failed to undergo postoperative subjective evaluation of dysmenorrhea. Inclusion criteria: sexually active women of fertile age with severe dysmenorrhea for more than six months who were unresponsive to medical treatment and had a clinical and/or ultrasonographic diagnosis of endometriosis. Exclusion criteria: pregnancy, women without midline dysmenorrhoea, breastfeeding, use of an intrauterine device, major medical diseases, psychiatric disorders, neurologic alterations of the lumbar‐sacral tract, previous pelvic surgery, history of severe abdominal or pelvic infection, presence of other gynaecologic diseases, body mass index of >30 kg/m2, history of alcohol or other drug abuse. Age: control group mean 31.8, SD 4.9; PSN surgery group mean 30.1, SD 3.7 Location: Catanzaro, Rome and Messina, Italy. | |
Interventions | Treatment: laparoscopic presacral neurectomy with conservative surgery for endometriosis. Control: conservative surgery for endometriosis. | |
Outcomes | Dysmenorrhoea, measured by a 100 mm visual analog scale that ranged from "least possible pain" to "worst possible pain". Frequency was expressed as the number of episodes per each cycle for dysmenorrhea and chronic pelvic pain. Adverse effects: Significant bleeding from middle sacral vein in 1 woman in treatment group, initial urinary retention in 2 women in treatment group; significant increase in operating time in treatment group (P value < 0.05). | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |
SD = standard deviation