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

Abstract

ObjeCtive To compare the effectiveness and acceptability of outpatient polypectomy with inpatient polypectomy. DesignPragmatic multicentre randomised controlled noninferiority 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 MeasuresThe 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. COnClusiOnsOutpatient 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 registratiOnInternational Clinical Trials Registry 65868569.

A patient-preference cohort study of office versus inpatient uterine polyp treatment for abnormal uterine bleeding

“…There was no increased risk of partial or failed polypectomy in the office group in the preference study which is contradictory to the results of the randomised OPT study [14] which found that office treatment was more likely to fail. This is likely to be due to unknown confounders and the small sample size in the inpatient group.…”

“…Women in equipoise were recruited to the randomised study [14] and those with a preference for treatment were asked to participate in the preference study as we describe here. Abnormal uterine bleeding included heavy menstrual bleeding, intermenstrual bleeding and postmenopausal bleeding.…”

The role of hysteroscopy in diagnosis of menstrual disorders

“…Increasingly, polypectomy is now performed under direct vision in the outpatient setting without general anaesthesia [8]. A recently completed large randomized controlled trial (RCT) comparing inpatient with outpatient polypectomy for AUB showed that there was no difference in efficacy, but a significant reduction in cost [32]. Further improvements in speed, acceptability, pain scores and failure rates have been made by using the new morcellator technologies [33].…”

Outpatient treatment for uterine polyps

“…6 Cooper and colleagues' trial (Outpatient Polyp Treatment, OPT) is the first large multicentre prospective randomised controlled trial evaluating the clinical effectiveness of outpatient versus inpatient polyp removal by hysteroscopy. 2 Previous studies reported an improvement in patients' symptoms after removal of polyps by hysteroscopy in the outpatient versus inpatient setting 7 along with good patient tolerability, low pain scores, and faster recovery after outpatient treatment. 8 In the OPT trial women were recruited from 31 outpatient hysteroscopy clinics in UK National Health Service hospitals: 72% of women allocated to outpatient polypectomy were treated in "see and treat" clinics.…”

“…The dominance of traditional inpatient dilatation and curettage is currently being challenged most recently by Cooper and colleagues in the linked study (doi:10.1136/bmj.h1398) evaluating outpatient diagnosis and treatment for women with uterine polyps, a common cause of intrauterine bleeding. 2 During dilatation and curettage the operator is unable to see inside the uterine cavity, and tissue is therefore removed in a blind manner. The procedure is usually done to rule out endometrial cancer, and although the diagnostic accuracy for detecting endometrial cancer is high it is moderate for other endometrial disease, such as uterine polyps.…”