A randomised controlled trial of outpatient polyp treatment for abnormal uterine bleeding
| ISRCTN | ISRCTN65868569 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65868569 |
| Protocol serial number | HTA 06/404/84 |
| Sponsor | University of Birmingham and Birmingham Women's NHS Foundation Trust (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 11/10/2007
- Registration date
- 15/11/2007
- Last edited
- 21/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
justin.clark@bwhct.nhs.uk
Contact information
Scientific
Birmingham Women's Hospital
Metchley Park Road
Edgbaston
Birmingham
B15 2TG
United Kingdom
| Phone | +44 (0)121 6074712 |
|---|---|
| justin.clark@bwhct.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled multi-centre equivalence trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled trial of Outpatient Polyp Treatment for abnormal uterine bleeding |
| Study acronym | OPT |
| Study objectives | 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. Added 01/09/2011: To test the hypothesis that in women with abnormal uterine bleeding associated with benign uterine polyp(s), outpatient polyp treatment (OPT) achieves as good, or no more than 25% worse (i.e. 90% successful v 67% successful), alleviation of bleeding symptoms compared to standard inpatient treatment at six months (principal objective). (Previous hypothesis at time of registration: 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?) More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/0640484 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0014/51413/PRO-06-404-84.pdf |
| Ethics approval(s) | South West Research Ethics Committee, 15/02/2008, ref: 08/H0206/6 |
| Health condition(s) or problem(s) studied | Abnormal uterine bleeding associated with a benign polyp |
| Intervention | Current interventions as of 01/09/2011: Outpatient polypectomy will be performed immediately following diagnosis at outpatient hysteroscopy in most instances, although some participants may have their outpatient treatment scheduled to a later date, depending upon local circumstances, within the following 8 weeks, as not all clinics are able to offer immediate 'see & treat' outpatient treatment. Polyp removal will be carried out under direct hysteroscopic vision using miniature mechanical or electrosurgical instruments, with or without the need for minor degrees of cervical dilatation and local anaesthesia (direct cervical infiltration or paracervical injection). Occasionally blind avulsion with small polypectomy forceps after hysteroscopic localisation may be required. Inpatient polypectomy will be performed within 8 weeks of the initial diagnosis at outpatient hysteroscopy. Inpatient 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 or spinal anaesthesia facilitates major degrees of cervical dilatation and manipulation of these larger diameter instruments within the uterine cavity. Previous 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. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Current primary outcome measure as of 01/09/2011: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 01/09/2011: |
| Completion date | 30/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 480 |
| Key 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 |
| Key exclusion criteria | 1. Hysteroscopic features suggesting malignant lesion 2. Additional pathology necessitating hysterectomy |
| Date of first enrolment | 01/04/2008 |
| Date of final enrolment | 30/09/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
B15 2TG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/04/2016: Plain English summary added.
25/10/2012: As of 27/07/2012 the overall trial end date has been extended from 31/03/2013 to 30/09/2013.
On 01/09/2011 the overall trial end date was extended from 31/03/2012 to 31/03/2013.
