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临床试验/NCT05378152
NCT05378152已完成不适用

Is Pipelle Biopsy of Benefit in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity?

Royal College of Surgeons, Ireland1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2022年9月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
82
试验地点
1
主要终点
Pain scores

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Postmenopausal
  • Postmenopausal bleeding
  • Tolerates hysteroscopy

排除标准

  • Premenopausal
  • Any lesion requiring biopsy at time of hysteroscopy
  • Obvious cause of bleeding from the vagina or cervix at time of hysteroscopy
  • History of endometrial hyperplasia/cancer

结局指标

主要结局

Pain scores

时间窗: Immediately after intervention, within 1 minute of carrying out intervention

Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain

次要结局

  • Cost saving(3 months)
  • Changes in follow up(3 months)

研究者

发起方
Royal College of Surgeons, Ireland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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