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Prospective Randomised Study (prospective + randomised_study)
Selected AbstractsRandomised comparison of Burch colposuspension versus anterior colporrhaphy in women with stress urinary incontinence and anterior vaginal wall prolapseBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 4 2000Mario Colombo Senior Registrar Objective To compare the Burch colposuspension and the anterior colporrhaphy in women with both stress urinary incontinence and advanced anterior vaginal wall prolapse (cystocele). Design Prospective randomised study. Setting Secondary referral centre, Urogynaecology Unit, San Gerardo Hospital, Monza, Italy. Sample Seventy-one women undergoing surgery for primary genuine stress incontinence and concurrent grade 2 or 3 cystocele (descending at or outside the vaginal introitus). Methods Full urodynamic investigation performed pre-operatively and repeated six months after surgery. Clinical follow up continued for 8 to 17 years. Main outcome measures Subjective (patient history) and objective (negative stress test result) cure of stress incontinence. Assessment of cystocele recurrence. Results Thirty (86%) of the 35 evaluable women who had the Burch colposuspension and 17 (52%) of the 33 evaluable women who had the anterior colporrhaphy were subjectively cured (OR 5.6, 95% CI 1.6 to 21.6; P= 0.005). Objective cure rates were 74% (26 of 35) and 42% (14 of 33), respectively (OR 3.9, 95% CI 1.3 to 12.5; P= 0.02). A recurrent cystocele of grade 2 or 3 with or without prolapse at other vaginal sites was recorded in 34% (12 of 35) and 3% (1 of 33) of women, respectively (OR 16.7, 95% CI 2.0 to 368.1; P= 0.003). Conclusions The Burch colposuspension was better in controlling stress incontinence but it lead to an unacceptable high rate of prolapse recurrence. The anterior colporrhaphy was more effective in restoring vaginal anatomy but it was accompanied by an unacceptable low cure rate of stress incontinence. Neither of the two operations is recommended for women who are suffering from a combination of stress incontinence and advanced cystocele. [source] Labour characteristics and uterine activity: misoprostol compared with oxytocin in women at term with prelabour rupture of the membranesBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 2 2000Suk Wai Ngai Assistant Professor Objective To compare the labour pattern and uterine activity of oral misoprostol with oxytocin for labour induction in women presenting with prelabour rupture of membranes at term. Design Prospective randomised study. Setting Department of Obstetrics and Gynaecology, Queen Mary Hospital, Hong Kong. Participants Eighty women presenting with prelabour rupture of membranes at term. Methods The women were randomised to receive either 100 ,g misoprostol orally every 4 hours to a maximum of three doses, or intravenous oxytocin infusion according to the hospital protocol. Intrauterine pressure transducers were inserted one hour before induction of labour in both groups of women. We compared the pattern of uterine activity, the induction-to-delivery interval, duration of labour, mode of delivery and neonatal outcome between the two groups. Results Both oxytocin and oral misoprostol caused an increase in uterine activity within one hour of labour induction. Peak uterine activity was reached 6,8 h after oral misoprostol, with persistent effects, and 8,10 h after oxytocin, requiring continuous titration of medication. The duration of labour was significantly reduced in nulliparous women, but not in those who were multiparous in the misoprostol group. The induction-to-delivery interval, the mode of delivery and the perinatal outcome were similar for the two groups. Conclusion Oral misoprostol caused earlier peak uterine activity, compared with oxytocin (6,8 h vs 8,10 h). Oral misoprostol was not only as effective as oxytocin in inducing labour in women at term with prelabour rupture of the membranes, but it reduced significantly the duration of labour in nulliparous women. [source] Is routine cervical dilatation necessary during elective caesarean section?AUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 3 2009A randomised controlled trial Objective: The purpose of this prospective randomised study was to determine the effect of routine cervical dilatation during elective caesarean section on maternal morbidity. Methods: Participants with indication for elective caesarean section were randomly allocated to two groups. Group A (n = 200) women with intraoperative cervical dilatation; group B (n = 200) women with no intraoperative cervical dilatation. Results: No demographic differences were observed between groups. There was no significant difference between groups in infectious morbidity (P = 0.87) (relative risk (RR) 1.11, 95% confidence interval (CI) 0.58,2.11), endometritis (P = 0.72) (RR 1.68, 95% CI 0.39,7.14), febrile morbidity (P = 0.66) (RR 1.21, 95% CI 0.51,2.87), wound infection (P = 0.82) (RR 1.11, 95% CI 0.44,2.81), endometritis (P = 0.72) (RR 1.68, 95% CI 0.39,7.14) or urinary tract infection (P = 1.00) (RR 1.00, 95% CI 0.28,3.50), and estimated blood loss (P = 0.2). However, group A had longer operative times compared with the group B (P = 0.01). Conclusion: Intraoperative digital cervical dilatation during elective caesarean section did not reduce blood loss and postoperative infectious morbidity. The routine digital cervical dilatation during elective caesarean section is not recommended. [source] The effect of early removal of indwelling urinary catheter on postoperative urinary complications in anterior colporrhaphy surgeryAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 3 2008Leila SEKHAVAT Objective: To assess whether immediate removal of an indwelling catheter after anterior colporrhaphy influences the rate of re-catheterisation and symptomatic urinary tract infections. Methods: A prospective randomised study conducted on 90 women divided into two groups who underwent anterior repair. The indwelling catheter was removed immediately (early catheter removal), and at least 24 h after the operation in case and control groups, respectively. The association between clinical variables and the duration of catheterisation and continuous data were analysed by ,2 test and two-tailed t -test, respectively. Excel and SPSS 15.0 software were used, and a P -value of 0.05 or less was considered to indicate statistically significant differences. Result: Symptomatic urinary tract infection was significantly lower in early catheter-removal group; also patients in this group reported significantly less pain and voiding disturbances. Only a few of women required re-catheterisation after failing to void and all were able to resume normal voiding, also had shorter ambulation time and hospital stay. Conclusion: Early removal of an indwelling catheter immediately after anterior colporrhaphy was not associated with adverse events and increased rate of re-catheterisation. In this group, symptomatic urinary tract infection was significantly lower. Moreover, early removal of indwelling catheters immediately after operation seemed to decrease the ambulation time and hospital stay. [source] Bed rest versus free mobilisation following embryo transfer: a prospective randomised studyBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 11 2004Zouhair O. Amarin Objective To evaluate the efficacy of two clinical methods of post-embryo transfer protocols in patients undergoing in vitro fertilisation. Design Prospective, randomised clinical trial. Setting Hospital-based clinic for reproductive medicine. Sample Women under 40 years of age who were undergoing in vitro fertilisation with GnRH pituitary down-regulation and controlled ovarian hyperstimulation. Methods Patients were randomised to rest for either 1 or 24 hours after embryo transfer. Main outcome measure Clinical pregnancy per cycle rate (the percentage of cycles started that demonstrated a live fetus on ultrasound examination performed at six or seven weeks of gestation). Results The clinical pregnancy rates were 21.5% for the 1-hour and 18.2% for the 24-hour post-embryo transfer groups. The implantation rate per embryo was significantly higher in the 1-hour group (14.4%) than in the 24-hour group (9%). Conclusion One-hour and 24-hour rest post-embryo transfer result in comparable rates of clinical pregnancy. However, 24-hour rest results in reduced implantation rate per embryo. [source] A comparison of segmental vs subtotal/total colectomy for colonic Crohn's disease: a meta-analysisCOLORECTAL DISEASE, Issue 2 2006P. P. Tekkis Abstract Objective, Using meta-analytical techniques the present study evaluated differences in short-term and long-term outcomes of adult patients with colonic Crohn's disease who underwent either colectomy with ileorectal anastomosis (IRA) or segmental colectomy (SC). Methods, Comparative studies published between 1988 and 2002, of subtotal/total colectomy and ileorectal anastomosis vs segmental colectomy, were used. The study end points included were surgical and overall recurrence, time to recurrence, postoperative morbidity and incidence of permanent stoma. Random and fixed-effect meta-analytical models were used to evaluate the study outcomes. Sensitivity analysis, funnel plot and meta-regressive techniques were carried out to explain the heterogeneity and selection bias between the studies. Results, Six studies, consisting of a total of 488 patients (223 IRA and 265 SC) were included. Analysis of the data suggested that there was no significant difference between IRA and SC in recurrence of Crohn's disease. Time to recurrence was longer in the IRA group by 4.4 years (95% CI: 3.1,5.8), P < 0.001. There was no difference between the incidence of postoperative complications (OR = 1.4., 95% CI 0.16,12.74) or the need for a permanent stoma between the two groups (OR = 2.75, 95% CI 0.78,9.71). Patients with two or more colonic segments involved were associated with lower re-operation rate in the IRA group, a difference which did not reach statistical significance (P = 0.177). Conclusions, Both procedures were equally effective as treatment options for colonic Crohn's disease however, patients in the SC group exhibited recurrence earlier than those in the IRA group. The choice of operation is dependent on the extent of colonic disease, with a trend towards better outcomes with IRA for two or more colonic segments involved. Since no prospective randomised study has been undertaken, a clear view about which approach is more suitable for localised colonic Crohn's disease cannot be obtained. [source] | ||||||||||