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

Cooper, Natalie A.M. and Clark, T. Justin and Middleton, Lee and Diwakar, Lavanya and Smith, Paul and Denny, Elaine and Roberts, Tracy and Stobert, Lynda and Jowett, Susan and Daniels, Jane and Thornton, Jim (2015) Outpatient versus inpatient uterine polyp treatment for abnormal uterine bleeding: randomised controlled non-inferiority study. BMJ: British Medical Journal, 350 . h1398/1-h1398/9. ISSN 0959-8138

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Abstract

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.

Item Type: Article
Additional Information: Jim Thornton is a part of Outpatient Polyp Treatment trial collaborative group.
Schools/Departments: University of Nottingham UK Campus > Faculty of Medicine and Health Sciences
University of Nottingham UK Campus > Faculty of Medicine and Health Sciences > School of Medicine > Division of Child Health, Obstetrics and Gynaecology
University of Nottingham UK Campus > Faculty of Medicine and Health Sciences > School of Medicine
Depositing User: Thornton, Jim
Date Deposited: 19 Feb 2016 15:03
Last Modified: 13 Sep 2016 15:01
URI: http://eprints.nottingham.ac.uk/id/eprint/31864

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