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Randomized Controlled Trial
. 2015 Mar 23:350:h1398.
doi: 10.1136/bmj.h1398.

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

Natalie A M Cooper  1 , T Justin Clark  2 , Lee Middleton  3 , Lavanya Diwakar  4 , Paul Smith  5 , Elaine Denny  6 , Tracy Roberts  4 , Lynda Stobert  7 , Susan Jowett  4 , Jane Daniels  3 ; OPT Trial Collaborative Group
Collaborators, Affiliations
Randomized Controlled Trial

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

Natalie A M Cooper et al. BMJ. .

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.

Trial registration: International Clinical Trials Registry 65868569.

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Conflict of interest statement

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.

Figures

None
Fig 1 Flow chart showing enrolment, randomisation, and follow-up of participants. A small number of women had more than one reoperation
None
Fig 2 Primary outcome (successful treatment, determined by the women’s assessment of their bleeding at six months) compared with margin of non-inferiority
See this image and copyright information in PMC

Comment in

References

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