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| Name | Class |
|---|---|
| The Rotunda Hospital | OTHER |
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Postmenopausal bleeding (PMB) is the occurrence of vaginal bleeding 12 months following a woman's last menstrual cycle. PMB represents one of the most common reasons for referral to gynaecology services. Approximately 10% of women with PMB will be found to have endometrial cancer. The gold standard of investigation of PMB is ambulatory gynaecology through the outpatient hysteroscopy clinic, which is often combined with Pipelle biopsy for endometrial sampling.
Up to 60% of women that present with PMB will have an atrophic-appearing cavity at hysteroscopy. This provides a challenge in obtaining a histological sample through both dilatation & curretage (D&C) and Pipelle biopsy. Often, scant tissue that is insufficient for clinical diagnosis is obtained.
Pipelle biopsy is associated with patient discomfort. It is also associated with costs related to the purchasing of equipment and the processing of samples in the laboratory to the sum of approximately 30 euro per sample. It is rare that a sample taken from an atrophic cavity will return any clinically meaningful result. A negative hysteroscopy reduces the probability of endometrial cancer to 0.6%.
This study aims to compare patients with PMB and atrophic-appearing cavity that undergo pipelle biopsy to those that do not. Differences in pain scores, cost saving and differences in clinical follow up will be assessed to evaluate the benefit of Pipelle biopsy in patients with PMB and atrophic-appearing cavity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pipelle biopsy | Active Comparator | This group will undergo an endometrial biopsy performed using a Pipelle catheter in the usual manner performed according to the physician either with or without a speculum and with or without a tenaculum. Local anaesthetic block may or may not be used as per clinical judgement. |
|
| No Pipelle biopsy | Sham Comparator | This group will undergo a sham procedure where a speculum is inserted into the vagina and then removed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pipelle biopsy catheter | Device | A speculum will be inserted into the vagina. A Pipelle biopsy catheter will be inserted through the cervix up to the fundus of the uterus. The internal piston will be withdrawn to create negative pressure. The catheter will be moved back and forth and rotated to collect the biopsy. The catheter will then be removed, followed by the speculum. The sample will be sent to the laboratory for assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores | Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain | Immediately before procedure, less than 5 minutes prior to starting hysteroscopy |
| Pain scores | Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain | Immediately after procedure, within 1 minute of finishing hysteroscopy |
| Pain scores | Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain | Immediately after intervention, within 1 minute of carrying out intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Cost saving | Cost saving between the two groups | 3 months |
| Changes in follow up | Changes in follow up between groups including the number of repeat OPH assessments, follow up visits, repeat ultrasound scans and other related hospital attendances., |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rotunda hospital | Dublin | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40669559 | Derived | Tunney DE, Yambasu DS, Gyawali DI, Gaughan DE, O'Dwyer DV, Harrity DC, Reidy DF, Ahmed DR, Molphy DZ, Asandei D, Salameh DF, Burke DN. Endometrial Biopsy Versus No Endometrial Biopsy with a Normal-Appearing Cavity During In-office Hysteroscopy for Postmenopausal Bleeding: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2025 Oct;32(10):914-920. doi: 10.1016/j.jmig.2025.07.007. Epub 2025 Jul 14. |
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|
| Sham procedure | Device | A speculum is inserted into the vagina and then removed |
|
| 3 months |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D004714 | Endometrial Hyperplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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