Contact information
Type
Scientific
Primary contact
Dr A Timmermans
ORCID ID
Contact details
Markstraat 42
Utrecht
3582 KM
Netherlands
anne_timmermans@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR302
Study information
Scientific title
Acronym
RaTTeP
Study hypothesis
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
Received from the local ethics committee
Study design
Multicentre randomised single-blind placebo-controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/09/2005
Overall trial end date
01/09/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Women with post-menopausal bleeding and endometrial thickness of more than 4 mm in whom an endometrial polyp is diagnosed during hysteroscopy.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
60
Participant exclusion criteria
1. Women with post-menopausal bleeding on tamoxifen treatment
2. Women with post-menopausal bleeding with (suspicion of) malignancy during hysteroscopy
Recruitment start date
01/09/2005
Recruitment end date
01/09/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Markstraat 42
Utrecht
3582 KM
Netherlands
Sponsor information
Organisation
St. Antonius Hospital (Netherlands)
Sponsor details
P.O. Box 2500
Nieuwegein
3430 EM
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary