Effect of a full bladder in ensuring easier entry of a sampling device into the womb
| ISRCTN | ISRCTN33938192 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33938192 |
| Secondary identifying numbers | MREC ID NO: 2021326-9984 |
- Submission date
- 10/06/2021
- Registration date
- 17/06/2021
- Last edited
- 07/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Pipelle sampling is a procedure where a small amount of tissue is taken from the lining of the womb using a small straw-like device. The aim of this study is to show that a full bladder improves the failure rate of pipelle sampling at the first attempt.
Who can participate?
Women aged over 18 years with abnormal uterine bleeding undergoing pipelle sampling
What does the study involve?
Patients are allocated at random (by chance alone) to either perform the procedure directly with the doctor in charge, or be asked to drink a bottle of water and hold on to their urine until they have the urge to pass urine. Subsequently, an ultrasound will be performed over the abdomen. Next, the doctor will insert a device into the patient's vagina to see the cervix. A pipelle (a small straw-like device) will be passed through the cervix to get the tissue of the patient's womb’s lining. After the sample is collected, all the instruments will be removed, and the procedure is considered done. Questionnaires are used to assess pain and satisfaction score after the procedure. Once the procedure is done, the patient will no longer be involved in this study.
What are the possible benefits and risks of participating?
If performing pipelle sampling with a full bladder is shown to reduce the failure rate, it may help to reduce the number of attempts and reduce the discomfort during the procedure.
Where is the study run from?
Pusat Perubatan Universiti Malaya (Malaysia)
When is the study starting and how long is it expected to run for?
March 2021 to June 2022
Who is funding the study?
Pusat Perubatan Universiti Malaya (Malaysia)
Who is the main contact?
Dr Erwina Hashim
erwinahashim@gmail.com
Contact information
Scientific
Department of Obstetrics & Gynaecology
University Malaya Medical Centre
Jalan Universiti
Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60 (0)192010405 |
|---|---|
| grow@ummc.edu.my |
Study information
| Study design | Single-blind single-centre prospective randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | ISRCTN33938192_PIS_17Mar2021.docx |
| Scientific title | Pipelle sampling with full bladder versus no intervention: a randomised clinical trial |
| Study acronym | PipFuB |
| Study objectives | Full bladder before pipelle sampling will reduce the failure rate during the first attempt of pipelle without cervical manipulation. |
| Ethics approval(s) | Approved 10/06/2021, Medical Research Ethics Committee, University of Malaya Medical Centre (Jln Profesor Diraja Ungku Aziz, 59100 Kuala Lumpur, Malaysia; +60 (0)3 7949 3209/2251; iresearch@ummc.edu.my), ref: 2021326-9984 |
| Health condition(s) or problem(s) studied | Endometrial sampling technique using pipelle sampler |
| Intervention | Patients who are indicated for pipelle sampling will be randomised to performing pipelle without intervention or pipelle with a full bladder. Patients randomised to full bladder group will be given 1 l of water to drink and are asked to hold their bladder for 1 hour before proceeding to pipelle sampling. Patient in the no intervention group may proceed to pipelle sampling directly. Both groups will have an ultrasound performed to look at bladder volume and endometrial cavity length. During this assessment, they will be asked if they have the sensation to urinate. The doctor then will proceed with pipelle sampling using Pipelle® CCD manufactured by Laboratoire CCD – CE0459. Randomisation to no intervention or full bladder was by opening a sealed opaque envelope. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Failure rate of performing pipelle sampling at first attempt without cervical manipulation (failure to perform a pipelle sampling is defined when the depth of the pipelle inserted is less than 4 cm) measured using patient records at the time of procedure |
| Secondary outcome measures | 1. Pain assessed using an 11-point visual numerical rating scale score from 0-10 (high score, greater pain) during the procedure 2. Patient satisfaction assessed by asking 'Please rate the satisfaction with regards to the procedure you had' using an 11-point visual numerical rating scale score from 0-10 (high score, greater satisfaction) immediately after the procedure is completed 3. Analgesia use post-procedure measured by reviewing patient notes immediately after the procedure 4. Duration to complete procedure, defined as the time from speculum inserted into the vagina to speculum removed during the procedure 5. The bladder's volume measured using ultrasound performed 1 hour after drinking 1 litre of fluid or when the patient has the sensation to urinate 6. Sensation to urinate assessed by asking, 'Do you have the sensation to urinate now?' to bladder volume calculated by ultrasound during ultrasound assessment 7. The need for additional manoeuvres during the procedure (cervical manipulation) measured using patient notes 8. Failure rate after the manoeuvre, defined as when the depth of pipelle inserted is less than 4 cm, or when the patient requested for the procedure to be stopped measured using patient notes 9. Complications developed during the procedure, mainly cervical trauma or syncopal attack following a vaso-vagal attack measured using patient notes if analgesia use immediately after the procedure |
| Overall study start date | 26/03/2021 |
| Completion date | 30/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 214 |
| Total final enrolment | 214 |
| Key inclusion criteria | 1. All women with abnormal uterine bleeding indicated for pipelle sampling 2. Age ≥18 years old |
| Key exclusion criteria | 1. A known stenotic cervical os 2. Having acute cervicitis 3. Intense anxiety 4. Had been diagnosed with bladder dysfunction 5. Needed general anaesthesia or local anaesthetics 6. Used analgesic drugs before the pre-procedure 7. Known history of malignancy, uterine anomalies, or leiomyoma distorts the cervical canal or uterine cavity 8. Had a history of failed office endometrial sampling procedure 9. Currently with a positive b-HCG test |
| Date of first enrolment | 01/07/2021 |
| Date of final enrolment | 31/05/2022 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kuala Lumpur
59100
Malaysia
Sponsor information
Hospital/treatment centre
Department of Obstetrics & Gynaecology
Jalan Universiti
Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60 (0)3 79494422 |
|---|---|
| ummc@ummc.edu.my | |
| Website | http://www.ummc.edu.my/ |
"ROR" |
https://ror.org/00vkrxq08 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 17/03/2021 | 08/07/2021 | No | Yes | |
| Protocol file | 17/03/2021 | 08/07/2021 | No | No | |
| Results article | 06/05/2024 | 07/05/2024 | Yes | No |
Additional files
- ISRCTN33938192_PIS_17Mar2021.docx
- Uploaded 08/07/2021
- ISRCTN33938192_PROTOCOL_17Mar2021.docx
- Uploaded 08/07/2021
Editorial Notes
07/05/2024: Publication reference and total final enrolment added.
08/07/2021: The participant information sheet has been uploaded. Uploaded protocol (not peer reviewed).
14/06/2021: Trial's existence confirmed by the Medical Research Ethics Committee, University of Malaya Medical Centre.
