Extract

Background and study aims Uterine polyps are small, soft, outgrowths from the lining of the womb (the uterus). In the majority of cases, the polyps are benign and are not cancerous. Symptoms include bleeding between periods, after sexual intercourse, or intermittent bleeding after the menopause. Polyps are usually diagnosed by ultrasound or by hysteroscopy (looking into the womb via the vagina with a long fine telescope). Polyps require investigation and can be treated in an outpatient clinic where they are removed with forceps under local anaesthetic. Alternatively, a general anaesthetic may be given to investigate the inside of the uterus and remove polyps. Currently, most doctors only offer the in-patient, general anaesthetic option but increasingly more will perform the outpatient polyp treatment (OPT). However, it is not known which method is better at removing polyps and improving the bleeding symptoms, or indeed which is preferred by women or is cheaper for the NHS. The aim of this study is to compare the effectiveness of OPT with the in-patient approach. Who can participate? Women who have irregular uterine bleeding caused by benign polyps that are suitable for removal by either approach What does the study involve? Participants are randomly allocated to either have the OPT straight away or to come back to the hospital as an in-patient. Before the hysteroscopy, women complete a questionnaire to rate the amount of bleeding they have, their sexual activity and their general quality of life, and again at 3, 6 and 12 months after treatment. Some of the participants are interviewed about how they feel about their treatment. The doctor records information about the completeness of polyp removal and any surgical complications or repeat procedures. Some of the participants are also asked to have a second hysteroscopy at 6 months to confirm whether the polyp has returned. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? Birmingham Women's Hospital (UK) When is the study starting and how long is it expected to run for? April 2008 to September 2013 Who is funding the study? NIHR Health Technology Assessment Programme - HTA (UK) Who is the main contact? Justin Clark [email protected]

Inclusion criteria

• Abnormal uterine bleeding associated with a benign polyp

Links

• isrctn
• ictrp