RESEARCH

Outpatient versus inpatient uterine polyp treatment for abnormal uterine bleeding: randomised controlled non-inferiority study Natalie A M Cooper,1 2 T Justin Clark,3 Lee Middleton,2 Lavanya Diwakar,4 Paul Smith,3 5 Elaine Denny,6 Tracy Roberts,4 Lynda Stobert,7 Susan Jowett,4 Jane Daniels,2 on behalf of the OPT trial collaborative group ЖЖEDITORIAL by Bosteels and Weyvers 1

Women’s Health Research Unit, Queen Mary University of London, UK 2 OPT Trial Office, Birmingham Clinical Trials Unit, College of Medical and Dental Sciences, Robert Aitken Institute for Clinical Research, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK 3 Birmingham Women’s NHS Foundation Trust, Birmingham, UK 4 Health Economics Unit, School of Health and Population Science, University of Birmingham, UK 5 School of Clinical and Experimental Medicine, University of Birmingham, UK 6 Centre for Health and Social Care Research, Birmingham City University, UK 7 School of Allied and Public Health Professions, Birmingham City University, UK Correspondence to: T Justin Clark [email protected] Cite this as: BMJ 2015;350:h1398 doi: 10.1136/bmj.h1398

This is a summary of a paper that was published on thebmj.com as BMJ 2015;350:h1398

STUDY QUESTION How effective is outpatient polypectomy compared with inpatient polypectomy under anaesthesia for women with abnormal uterine bleeding? SUMMARY ANSWER Outpatient polypectomy was noninferior to inpatient polypectomy for effectively treating bleeding symptoms but failure rates were higher and the acceptability of the procedure was slightly lower. WHAT IS KNOWN AND WHAT THIS PAPER ADDS Published small observational studies failed to provide reliable estimates of relative effectiveness. This study identified no difference in improvement of symptoms between treatment settings and highlights the overall safety, feasibility, and acceptability of outpatient polypectomy.

Design This was a pragmatic, multicentre, randomised controlled non-inferiority study. We randomised eligible women using a minimisation algorithm to outpatient or inpatient poly­ pectomy in a 1:1 ratio through a centralised randomisation service. Outpatient polypectomies were performed in outpatient hysteroscopy clinics, and inpatient procedures were undertaken in operating theatres, under general or regional anaesthesia. Outpatient polyp removal was carried out under direct hysteroscopic vision using miniature instruments, with or without the need for cervical dilatation and local anaesthesia. Blind avulsion with small poly­pectomy forceps was also allowed. In addition, women allocated inpatient polypectomy could have traditional dilatation and curettage or removal using a resectoscope. Participants and setting Women who attended with abnormal uterine bleeding and were found to have uterine polyps at diagnostic hysteroscopy were eligible for the study. 507 participants were recruited from outpatient hysteroscopy clinics in 31 UK National Health Service hospitals. Successful treatment, determined by the women’s self reported assessment of bleeding at six months, compared with margin of non-inferiority Margin of non-inferiority (0.75) Intention to treat Six months One year Two years Per protocol Six months One year Two years 0.5

0.7

Favours inpatient polypectomy

1 Relative risk (95% CI)

Primary outcome The primary outcome was successful treatment of bleeding symptoms at six months, with a prespecified non-inferiority margin of 25%. Main results and the role of chance 73% (166/228) of women in the outpatient group and 80% (168/211) in the inpatient group reported successful treatment at six months (intention to treat relative risk 0.91, 95% confidence interval 0.82 to 1.02; per protocol relative risk 0.92, 0.82 to 1.02). The lower ends of the confidence intervals showed that outpatient polypectomy was at most 18% worse than inpatient treatment; within the 25% margin of non-inferiority. This translates to a numberneeded-to-treat-for-a-harm of 15 with outpatient treatment (95% confidence interval number needed to treat to harm 6 to number needed to benefit 39). Failure to remove polyps was higher (19% v 7%; relative risk 2.5, 1.5 to 4.1) and acceptability of the procedure was lower (83% v 92%; 0.90, 0.84 to 0.97) in the outpatient group. Harms Four uterine perforations (4/233, 2%) occurred in the inpatient group. One woman required an indwelling catheter after inpatient polypectomy. No serious adverse events occurred in the outpatient group. Bias, confounding, and other reasons for caution Limitations of the study include the variation in the practice of polypectomy with several techniques being utilised. This flexibility was allowed for pragmatic reasons; however, there was greater variation in the outpatient group. The non-inferiority level of 25% might be considered large, but this was selected based on the perceived advantages of outpatient treatment—namely, immediacy, convenience, and avoidance of general anaesthesia. Generalisability to other populations The multicentre design of the study makes the results applicable across the United Kingdom. Study funding/potential competing interests This study was funded by the National Institute of Health Research Health Technology Assessment Programme (06/404/84). TJC receives personal fees from Johnson & Johnson, Smith & Nephew, and Hologic (courses), outside the submitted work, and TJC and PS received a grant from Smith & Nephew during the conduct of the study, for a trial comparing techniques for outpatient polypectomy. Trial registration number International Clinical Trial Registry 65868569.

the bmj | 11 April 2015

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Outpatient versus inpatient uterine polyp treatment for abnormal uterine bleeding: randomised controlled non-inferiority study.

To compare the effectiveness and acceptability of outpatient polypectomy with inpatient polypectomy...
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