Condition category
Urological and Genital Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
28/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.antonius.net/

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

Publication citations

Additional files

Editorial Notes