A randomised controlled trial of Outpatient Polyp Treatment for abnormal uterine bleeding | Not Recruiting
A randomised controlled trial of Outpatient Polyp Treatment for abnormal uterine bleeding
OPT
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Abnormal uterine bleeding associated with a benign polyp
Mr Justin Clark
+44 (0)121 6074712
See all trial contact details
Primary Contact Details
Not Recruiting
Recruitment Status
ISRCTN65868569
Primary Trial ID Number
Summary
Not provided at time of registration
Research Details
  • 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 On 01/09/2011 the overall trial end date was extended from 31/03/2012 to 31/03/2013. 25/10/2012: As of 27/07/2012 the overall trial end date has been extended from 31/03/2013 to 30/09/2013.
Phase
Sorry, this information is not available
Study Design
Randomised controlled multi-centre equivalence trial
Study Type
Interventional
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 Measures
  • Current primary outcome measure as of 01/09/2011:
  • The patient's own assessment of bleeding symptoms at 6 months, using a dichotomous outcome measure, will be used to establish if the treatment has been successful. The question used for this measure will be dependent on whether the patient is pre or post-menopausal, predominant complaint at randomisation and type of HRT they may be using. Further details can be seen in Figure 2 (protocol v2.2 page 9). In all cases a 'yes' response will be defined as a success.
  • Previous primary outcome measure:
  • 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 Measures
  • Current secondary outcome measures as of 01/09/2011:
  • The following secondary outcomes will be assessed by a booklet sent to the women at home containing questionnaires/questions at baseline, 6, 12 and 24 months post-randomisation:
  • 1. Shaw Menorrhagia assessment scale A multi-attribute utility, designed to measure the impact of heavy menstrual bleeding (menorrhagia) upon HRQL
  • 2. Likert scale. All patients will be asked how their bleeding has responded to treatment using a Likert scale with four response options
  • 3. Health related quality of life measured by EuroQol EQ-5D Instrument
  • 4. Visual analogue scale (VAS) It is now well established that objective measures of blood loss are not particularly relevant to women's subjective perception of bleeding symptoms
  • Previous secondary outcomes measures:
  • 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.
Publication(s)
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26240949
Result Reports
Sorry, this information is not available
Gender
Female
Age Range
Not Specified
Who Can Participate
Patient
Number of Participants
480
Participant 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
Participant Exclusion Criteria
  • 1. Hysteroscopic features suggesting malignant lesion
  • 2. Additional pathology necessitating hysterectomy
Trial Location(s)
Birmingham Womens Hospital
Birmingham
West Midlands
B15 2TG
Trial Contact(s)
Primary Trial Contact
Mr Justin Clark
JUSTIN.CLARK@bwhct.nhs.uk
+44 (0)121 6074712
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
A randomised controlled trial of Outpatient Polyp Treatment for abnormal uterine bleeding
EudraCT Number
Sorry, this information is not available
Funder(s)
  • NIHR Health Technology Assessment Programme - HTA (UK)
Other Study ID Numbers
HTA 06/404/84
Sponsor(s)
University of Birmingham and Birmingham Women's NHS Foundation Trust (UK)
Key Dates

Recruitment Start Date

01 Apr 2008

Recruitment End Date

30 Sep 2013

Trial Start Date

01 Apr 2008

Trial End Date

30 Sep 2013

Date Assigned

15 Nov 2007

Last Updated

05 Aug 2015