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| A randomised controlled trial of Outpatient Polyp Treatment for abnormal uterine bleeding |
| Source of record | UK Trials |
| ISRCTN | ISRCTN65868569 |
| Date ISRCTN assigned | 15/11/2007 |
| Local reference number(s) | HTA 06/404/84 |
| Public title | A randomised controlled trial of Outpatient Polyp Treatment for abnormal uterine bleeding |
| Scientific title | |
| Acronym | OPT |
| Disease/condition/study domain | Abnormal uterine bleeding associated with a benign polyp. |
| Study hypothesis | Abnormal uterine bleeding is one of the four most common reasons for consulting a general practitioner and accounts for 70% of all referrals to hospital gynaecology clinics, making this complaint one of the commonest problems in gynaecology. With the advent of high-resolution pelvic ultrasound and hysteroscopic diagnosis, it has become clear that abnormal bleeding is associated with uterine polyps in between 20-30% of cases. This pattern is found to affect both pre- and postmenopausal women across all age groups. The improved diagnostic accuracy has led to the increased use of surgical intervention for the removal of polyps (polypectomy), a procedure that is universally practised to resolve symptoms and to obtain tissue for histological examination. Hypothesis: In women with abnormal uterine bleeding associated with benign uterine polyp(s), does Outpatient Polyp Treatment (OPT) achieve as good, or no more than 15% worse, alleviation of bleeding symptoms compared to standard inpatient treatment at six months? |
| Design/methodology | A multi-centre, randomised controlled equivalence trial. |
| Research ethics review | To be submitted to the National Research Ethics Service (NRES) in November 2007. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Abnormal uterine bleeding requiring diagnostic microhysteroscopy 2. Finding of a benign polyp (glandulocystic or pedunculated / grade 0 fibroid) on diagnostic microhysteroscopy 3. No hysteroscopic features suspicious of malignancy 4. Need for polypectomy |
| Participants - exclusion criteria | 1. Hysteroscopic features suggesting malignant lesion 2. Additional pathology necessitating hysterectomy |
| Patient information material | |
| Anticipated start date | 01/03/2008 |
| Anticipated end date | 31/12/2011 |
| Status of trial | Ongoing |
| Target number of participants | 480 |
| Interventions | Outpatient uterine polypectomy will be performed under direct hysteroscopic vision using miniature mechanical or electrosurgical instruments with or without the need for minor degrees of cervical dilatation. Occasionally blind avulsion with small polypectomy forceps after hysteroscopic localisation may be required. Inpatient uterine polypectomy will be performed by traditional Dilatation and endometrial Curettage (D&C), blind avulsion with or without prior localising hysteroscopy or under direct vision using an operative hysteroscope. In most instances, wide dilation of the cervical canal will be required to accommodate the larger diameter inpatient instruments within the uterus. General anaesthesia facilitates major degrees of cervical dilatation and manipulation of these larger diameter instruments within the uterine cavity. |
| Primary outcome measure(s) | Abnormal uterine bleeding (post-menopausal, unscheduled bleeding on Hormone Replacement Therapy [HRT]/tamoxifen or intermenstrual bleeding) at 6 months measured by visual analogue scale (0 = no bleeding; 10 = continuous bleeding) |
| Secondary outcome measure(s) | The following secondary outcomes will be assessed by a booklet sent to the women at home containing questionnaires/questions at baseline, 3, 6, 12 and 24 months post-randomisation: 1. Abnormal uterine bleeding (as above) measured at 3, 12 and 24 months 2. Health related quality of life measured by the multi-attribute utility menorrhagia assessment scale (if type of abnormal uterine bleeding is menorrhagia) 3. Satisfaction with treatment outcome 4. Sexual function measured by Sexual Activity Questionnaire 5. Health related quality of life measured by EuroQol EQ-5D Instrument 6. Patient anxiety and preference at baseline 7. Patient acceptability of uterine polypectomy (OPT vs inpatient treatment) 8. Data on economic endpoints (i.e. health resource utilisation e.g. general practice and hospital visits, days off work etc.) at 3, 6 and 12 months 9. Other measures will include information on technical feasibility (baseline) and complications of surgery (baseline, 3, 6 and 12 months). In addition we will perform a follow-up diagnostic outpatient microhysteroscopy at six months to assess completeness of treatment. The uterine cavity will be examined for persistence or recurrence of uterine polyp(s) and the presence of iatrogenic uterine adhesions. |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | University of Birmingham and Birmingham Women's Healthcare NHS Trust (UK) |
| Sponsor details | c/o Dr Brendan Laverty University of Birmingham Edgbaston Birmingham United Kingdom B15 2TT |
| Sponsor telephone | +44 (0)121 414 7618 |
| Sponsor email | b.w.laverty@bham.ac.uk |
| Contact name | Dr Justin Clarke |
| Contact details | Birmingham Women's Hospital Metchley Park Road Edgbaston Birmingham United Kingdom B15 2TG |
| Contact telephone | 0121 6074712 |
| Contact email | JUSTIN.CLARK@bwhct.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN65868569 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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