Outpatient versus inpatient uterine polyp treatment for abnormal uterine bleeding: randomised controlled non-inferiority studyBMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h1398 (Published 23 March 2015) Cite this as: BMJ 2015;350:h1398
- Natalie A M Cooper, academic clinical lecturer12,
- T Justin Clark, consultant and honorary professor of obstetrics and gynaecology3,
- Lee Middleton, senior medical statistician2,
- Lavanya Diwakar, research fellow4,
- Paul Smith, research fellow35,
- Elaine Denny, emeritus professor of health sociology6,
- Tracy Roberts, professor of health economics4,
- Lynda Stobert, senior lecturer7,
- Susan Jowett, senior lecturer4,
- Jane Daniels, senior research fellow2
- on behalf of the OPT trial collaborative group
- 1Women’s Health Research Unit, Queen Mary University of London, UK
- 2OPT 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
- 3Birmingham Women’s NHS Foundation Trust, Birmingham, UK
- 4Health Economics Unit, School of Health and Population Science, University of Birmingham, UK
- 5School of Clinical and Experimental Medicine, University of Birmingham, UK
- 6Centre for Health and Social Care Research, Birmingham City University, UK
- 7School of Allied and Public Health Professions, Birmingham City University, UK
- Correspondence to: T Justin Clark
- Accepted 5 February 2015
Objective To compare the effectiveness and acceptability of outpatient polypectomy with inpatient polypectomy.
Design Pragmatic multicentre randomised controlled non-inferiority study.
Setting Outpatient hysteroscopy clinics in 31 UK National Health Service hospitals.
Participants 507 women who attended as outpatients for diagnostic hysteroscopy because of abnormal uterine bleeding and were found to have uterine polyps.
Interventions Participants were randomly assigned to either outpatient uterine polypectomy under local anaesthetic or inpatient uterine polypectomy under general anaesthesia. Data were collected on women’s self reported bleeding symptoms at baseline and at 6, 12, and 24 months. Data were also collected on pain and acceptability of the procedure at the time of polypectomy.
Main outcome measures The primary outcome was successful treatment, determined by the women’s assessment of bleeding at six months, with a prespecified non-inferiority margin of 25%. Secondary outcomes included generic (EQ-5D) and disease specific (menorrhagia multi-attribute scale) quality of life, and feasibility and acceptability of the procedure.
Results 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). 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 Quality of life did not differ significantly between the groups. Four uterine perforations, one of which necessitated bowel resection, all occurred in the inpatient group.
Conclusions Outpatient polypectomy was non-inferior to inpatient polypectomy. Failure to remove a uterine polyp was, however, more likely with outpatient polypectomy and acceptability of the procedure was slightly lower.
Trial registration International Clinical Trials Registry 65868569.
We thank the women who participated in the Outpatient Polyp Treatment trial; the trial steering committee: Jim Thornton (chair), Jon Deeks (independent statistician), Peter O’Donovan (independent gynaecologist), Stavros Petrou (independent health economist), and Elaine Nicholls (patient representative); the independent data monitoring and ethics committee: Mary-Ann Lumsden (chair), Siladitya Bhattacharya (independent gynaecologist), and Carol Cummins (independent statisticians); Richard Gray for initial statistical advice; and past and present members of the Outpatient Polyp Treatment trial project management team: Laura Gennard, Liz Brettell, Lisa Leighton, and Enid Darby (trial management); Tracy Bingham and Susan Sargent (research nurses); Mary Connor and Sian Jones (surgical advisors); Versha Cheed (statistics); and Nicholas Hilken (database programmers).
We thank our National Health Service colleagues who supported recruitment for the trial: Barnsley District General Hospital, South Yorkshire: K Cannon, KA Farag, K Raychaudhuri, M Reid, A Zahid; Birmingham Heartlands/Solihull Hospital, Birmingham: J Blunn, S Guruswami, S Irani, D Robinson; Birmingham Women’s Hospital, Birmingham: T Bingham, TJ Clark, NAM Cooper, J Gupta, S Madari, D Mellers, S O’Connor, C O’Hara, M Pathak, V Preece, E Sangha, M Shehmar, P Trinham, A Wilson; Bishop Aukland General Hospital, County Durham: J Dent, J Macdonald, P Sengupta; Blackpool Victoria Hospital, Blackpool: C Brookes, J Davies; Bradford Royal Infirmary, Bradford: M Jackson, S Jones, H Ludkin, S Riddiough; Castle Hill Hospital, East Yorkshire: J Allen, T Cathcart, D Cox, S Ford, L Kenny, K Phillips, N Rawal, A Rodgers, J Siddiqui; Chelsea and Westminster Hospital, London: A Dine-Atkinson, S Kalkur, G Merriner, J Ben-Nagi, A Raza, R Richardson; University Hospital of North Staffordshire, Stoke-on Trent: I Hassan; City Hospital, Sunderland: D Edmundson, J Chamberlain, A Barge, P Wake, D Milford, E Walton; Countess of Chester Hospital, Chester: S Arnold, M Blake, MJ McCormack, N Naddad, J Hane, S Wood; Kidderminster Hospital, Worcester: M Labib, T Martin, S Moss, M Pathak; Liverpool Women’s Hospital, Liverpool: N Aziz, L Harris, D Pattison; Manor Hospital, Walsall: J Pepper; Musgrove Park Hospital, Taunton: M Escott, G Fender; New Cross Hospital, Wolverhampton: M Saeed; Newham University Hospital, Plaistow: A Antoniou, R Chenoy; Norfolk and Norwich University Hospital, Norwich: E Morris, M Sule; Ormskirk and District General Hospital, Southport: A Cope, S Sharma, T Taylor; Queen Charlotte’s and Chelsea Hospital, London: N Panay, C Rothan; Queen’s Hospital, Romford: A Coker; Royal Blackburn Hospital, Blackburn: M Abdel-Aty, K Bhatia, S Gardiner, W Myint, M Willett; Royal Hallamshire Hospital, Sheffield: V Brown, C Bonner, M Connor, S Stillwell; Royal Infirmary of Edinburgh, Edinburgh: A Horne, S Milne, J Rowan; Sandwell General Hospital, West Midlands: A Ewies, J Kabukoba; Shotley Bridge Hospital, County Durham: J Dent, P Sengupta; St Mary’s Hospital, Manchester: R Biancardi, K Donnelly, L Dwyer, K Naidoo, I Pinton; Stafford Hospital, Stafford: K Chin, T Harrison, J Roger, D Sirdefield, J Stacey; Royal Oldham Hospital, Oldham: Z Anjum, N Aziz; The Royal Victoria Infirmary, Newcastle Upon Tyne: J Bainbridge, G Cosgrove, A Desai, J Gebbie, D Koleskas, P Ranka, M Roberts; Whiston Hospital, Merseyside: C Cunningham, C Nwosu, N Aziz.
Contributors: TJC, LM, ED, TR, SJ, and JD designed the study as co-applicants. TJC oversaw the running of the trial and all the authors contibuted to the ongoing management of the trial. NAMC, TJC, and the Outpatient Polyp Treatment trial collaborative group recruited patients to the trial. NAMC, TJC, LD, PS, ED, LS, and the Outpatient Polyp Treatment trial collaborative group collected data for the trial. LM performed the statistical analysis. TR, SJ, and LD performed the parallel cost efectiveness analysis. ED and LS evaluated the qualitative data. The mansucript was drafted by NAMC and TJC with contributions from LM (statistics) and ED (qualitative study). All the authors contributed to the interpretation of the results of the study and revised and reviewed the paper. They are the guarantors. The Birmingham Clinical Trials Unit did the randomisation and data management and monitoring. Neither the funder nor sponsor had any role in study design, data collection, interpretation or analysis, or in writing the report for publication. The authors had full access to all the data from the study. The authors vouch for the accuracy and completeness of the data and analyses.
Funding: The study sponsors were the University of Birmingham and Birmingham Women’s NHS Foundation Trust. The study was funded by the National Institute of Health Research (NIHR) Health Technology Assessment Programme (06/404/84). The views and opinions expressed in this article are those of the authors and do not necessarily reflect those of the NIHR Health Technology Assessment Programme, the NIHR, the National Health Service, or the English Department of Health.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: TJC receives personal fees (courses), outside the submitted work 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; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: This study was approved by the South West Research Ethics Committee (08/H0206/6).
Data sharing: The full dataset is available from the corresponding author ().
Transparency: The corresponding author (TJC) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
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