Randomised controlled Trial of Treatment of endometrial Polyps in case of post-menopausal bleeding
| ISRCTN | ISRCTN73825127 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73825127 |
| Secondary identifying numbers | NTR302 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 23/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A Timmermans
Scientific
Scientific
Markstraat 42
Utrecht
3582 KM
Netherlands
| anne_timmermans@hotmail.com |
Study information
| Study design | Multicentre randomised single-blind placebo-controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | Randomised controlled Trial of Treatment of endometrial Polyps in case of post-menopausal bleeding |
| Study acronym | RaTTeP |
| Study objectives | Resection of endometrial polyp(s) in women with post-menopausal bleeding and endometrial thickness of more than 4 mm will lead to less recurrent bleeding than in women in whom no resection is performed. |
| Ethics approval(s) | Received from the local ethics committee |
| Health condition(s) or problem(s) studied | Endometrial polyps, post-menopausal bleeding |
| Intervention | Resection will take place in the same session in which the polyp is diagnosed. Resection is performed following standard procedures used in the residential hospital. Resection of endometrial polyp is performed by the hysteroscopist using the instruments of his/her choice. In general smaller polyps (less than 5 mm) will be resected using mechanical instruments. Larger polyps will be resected using electrosurgical material, i.e. the monopolar polypsnare in or the bipolar electrode. The polyp is resected completely at its stalk. Resections can occur in more than one piece if necessary. In patients that are randomised for expectant management a sham resection procedure will be performed during 5 minutes. |
| Intervention type | Other |
| Primary outcome measure | Recurrence of post-menopausal bleeding |
| Secondary outcome measures | 1. Quality of life will be assessed using several standard self-administered psychometric measures with established reliability and validity: 1.1. 36-item Short Form Health Survey (SF-36) 1.2. State Trait Anxiety Score (STAI) 2. Patient satisfaction will be assessed using a Visual Analogue Scale (VAS) score |
| Overall study start date | 01/09/2005 |
| Completion date | 01/09/2007 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 60 |
| Key inclusion criteria | Women with post-menopausal bleeding and endometrial thickness of more than 4 mm in whom an endometrial polyp is diagnosed during hysteroscopy. |
| Key exclusion criteria | 1. Women with post-menopausal bleeding on tamoxifen treatment 2. Women with post-menopausal bleeding with (suspicion of) malignancy during hysteroscopy |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Markstraat 42
Utrecht
3582 KM
Netherlands
3582 KM
Netherlands
Sponsor information
St. Antonius Hospital (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 2500
Nieuwegein
3430 EM
Netherlands
| Website | http://www.antonius.net/ |
|---|---|
"ROR" |
https://ror.org/01jvpb595 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | report | 01/09/2009 | 23/10/2020 | Yes | No |
Editorial Notes
23/10/2020: Publication reference added.
