A randomised controlled trial of outpatient versus inpatient polyp treatment (OPT) for abnormal uterine bleeding

Clark, T.J. and Middleton, L.J. and Cooper, N.A. and Diwakar, L. and Denny, E. and Smith, P. and Gennard, L. and Stobert, L. and Roberts, T.E. and Cheed, V. and Bingham, T. and Jowett, S. and Brettell, E. and Connor, M. and Jones, S.E. and Daniels, J.P. (2015) A randomised controlled trial of outpatient versus inpatient polyp treatment (OPT) for abnormal uterine bleeding. Health Technology Assessment, 19 (61). pp. 1-194. ISSN 13665278

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Abstract

Background: Uterine polyps cause abnormal bleeding in women and conventional practice is to remove them in hospital under general anaesthetic. Advances in technology make it possible to perform polypectomy in an outpatient setting, yet evidence of effectiveness is limited. Objectives: To test the hypothesis that in women with abnormal uterine bleeding (AUB) associated with benign uterine polyp(s), outpatient polyp treatment achieved as good, or no more than 25% worse, alleviation of bleeding symptoms at 6 months compared with standard inpatient treatment. The hypothesis that response to uterine polyp treatment differed according to the pattern of AUB, menopausal status and longer-term follow-up was tested. The cost-effectiveness and acceptability of outpatient polypectomy was examined. Design: A multicentre, non-inferiority, randomised controlled trial, incorporating a cost-effectiveness analysis and supplemented by a parallel patient preference study. Patient acceptability was evaluated by interview in a qualitative study. Setting: Outpatient hysteroscopy clinics and inpatient gynaecology departments within UK NHS hospitals. Participants: Women with AUB-defined as heavy menstrual bleeding (formerly known as menorrhagia) (HMB), intermenstrual bleeding or postmenopausal bleeding-and hysteroscopically diagnosed uterine polyps.Interventions: We randomly assigned 507 women, using a minimisation algorithm, to outpatient polypectomy compared with conventional inpatient polypectomy as a day case in hospital under general anaesthesia. Main outcome measures: The primary outcome was successful treatment at 6 months, determined by the woman’s assessment of her bleeding. Secondary outcomes included quality of life, procedure feasibility, acceptability and cost per quality-adjusted life-year (QALY) gained. Results: At 6 months, 73% (166/228) of women who underwent outpatient polypectomy were successfully treated compared with 80% (168/211) following inpatient polypectomy [relative risk (RR) 0.91, 95% confidence interval (CI) 0.82 to 1.02]. The lower end of the CIs showed that outpatient polypectomy was at most 18% worse, in relative terms, than inpatient treatment, within the 25% margin of non-inferiority set at the outset of the study. By 1 and 2 years the corresponding proportions were similar producing RRs close to unity. There was no evidence that the treatment effect differed according to any of the predefined subgroups when treatments by variable interaction parameters were examined. Failure to completely remove polyps was higher (19% vs. 7%; RR 2.5, 95% CI 1.5 to 4.1) with outpatient polypectomy. Procedure acceptability was reduced with outpatient compared with inpatient polyp treatment (83% vs. 92%; RR 0.90, 95% CI 0.84 to 0.97). There were no significant differences in quality of life. The incremental cost-effectiveness ratios at 6 and 12 months for inpatient treatment were £1,099,167 and £668,800 per additional QALY, respectively. Conclusions: When treating women with AUB associated with uterine polyps, outpatient polypectomy was non-inferior to inpatient polypectomy at 6 and 12 months, and relatively cost-effective. However, patients need to be aware that failure to remove a polyp is more likely with outpatient polypectomy and procedure acceptability lower. © Queen’s Printer and Controller of HMSO 2015.

Item Type: Article
Uncontrolled Keywords: adult, ambulatory surgery, Article, clinical effectiveness, conscious sedation, controlled study, cost effectiveness analysis, cost utility analysis, endometrium polyp, European Quality of Life 5 Dimensions, female, follow up, general anesthesia, hospitalization cost, human, major clinical study, menorrhagia, Menorrhagia Multi Attribute Scale, metrorrhagia, multicenter study, patient preference, patient satisfaction, peroperative complication, polypectomy, postmenopausal bleeding, postmenopause, postoperative complication, postoperative pain, premenopause, qualitative research, quality adjusted life year, quality of life assessment, randomized controlled trial, semi structured interview, United Kingdom, uterus bleeding, uterus perforation, visual analog scale
Subjects: A300 Clinical Medicine
B700 Nursing
B900 Others in Subjects allied to Medicine
Divisions: UoA Collections > UoA 03: Allied Health Professions, Dentistry, Nursing & Pharmacy
Faculty of Health, Education and Life Sciences > Centre for Social Care, Health and Related Research (C-SHARR) > Quality of Care
Depositing User: Hussen Farooq
Date Deposited: 08 Nov 2016 15:40
Last Modified: 08 Nov 2016 15:40
URI: http://www.open-access.bcu.ac.uk/id/eprint/1619

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