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| Name | Class |
|---|---|
| Al Adan Hospital Kuwait | INDUSTRY |
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Pipelle is the most commonly used outpatient endometrial biopsy device. Pipelle endometrial biopsy can diagnose 90% of endometrial cancer cases. Pipelle endometrial biopsy is one of the first-line diagnostic procedures for women presenting with abnormal peri- and post-menopausal vaginal bleeding.
Insufficient samples are obtained in 5-23% of cases. In Adan Hospital, a retrospective analysis of all outpatient endometrial samples sent to the histopathology department from April- to October 2024 study showed an insufficient sample percentage of 32% This may be attributed to factors such as patients, equipment, and physicians.
This project aims to improve the endometrial biopsy results by Identifying these factors in the Adan hospital setting, Implementing measures to modify these factors, and finally re-auditing the endometrial biopsy results after six months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Improving technique | Other | A checklist was developed to ensure the important steps were followed, with tips for obtaining a more adequate sample. This checklist was put in the outpatient procedures room, and each physician performing a biopsy was asked to fill it out. Also, a diagram containing illustrative images with the basic steps was put in the procedures room. The topic was covered in the biweekly scientific meeting, and all factors attributed to the inadequate sample were discussed. The department lead mentioned the topic in the OBGYN department's private messaging group. It was finally mentioned in the morning meeting. | ||
| Using hysteroscopy in candidate patients | Other | Patients with focal lesions on ultrasound will undergo hysteroscopy and biopsy instead of blind endometrial sampling. Patient with stenosed cervix or failed previous sampling might also undergo hysteroscopic guided biopsy. | ||
| Analgesia | Other | Analgesia in the form of paracetamol or NSAIDs might be given to some patients 30- 60 minutes before the procedure to reduce the procedure-associated pain and the resultant failure to complete it and obtain an adequate sample. |
| Measure | Description | Time Frame |
|---|---|---|
| Adequacy of the sampled endometrial specimen for histopathology diagnosis | six months |
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Inclusion Criteria:
Exclusion Criteria:
Endometrial biopsy for females with abnormal uterine bleeding
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All patients undergoing outpatient endometrial sampling
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adan hospital | Recruiting | Kuwait | Al Ahmadi | 47000 | Kuwait |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36477274 | Background | Andrews B, Quick K, MacLeod E, Edwards K, Rone BK. Cervical bleeding with cervical stabilization during IUD placement: allis clamp versus single-tooth tenaculum, a randomized control trial. Arch Gynecol Obstet. 2023 Apr;307(4):1015-1019. doi: 10.1007/s00404-022-06784-x. Epub 2022 Dec 7. | |
| 19004401 | Background |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
Patient confidentiality. It may be shared with reasonable request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 4, 2024 | Dec 2, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000698 | Analgesia |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
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Endometrial biopsy samples
| Sierecki AR, Gudipudi DK, Montemarano N, Del Priore G. Comparison of endometrial aspiration biopsy techniques: specimen adequacy. J Reprod Med. 2008 Oct;53(10):760-4. |
| 29683909 | Background | ACOG Committee Opinion No. 734: The Role of Transvaginal Ultrasonography in Evaluating the Endometrium of Women With Postmenopausal Bleeding. Obstet Gynecol. 2018 May;131(5):e124-e129. doi: 10.1097/AOG.0000000000002631. |
| 23635706 | Background | ACOG committee opinion no. 557: Management of acute abnormal uterine bleeding in nonpregnant reproductive-aged women. Obstet Gynecol. 2013 Apr;121(4):891-896. doi: 10.1097/01.AOG.0000428646.67925.9a. |
| 35117374 | Background | Terzic MM, Aimagambetova G, Terzic S, Norton M, Bapayeva G, Garzon S. Current role of Pipelle endometrial sampling in early diagnosis of endometrial cancer. Transl Cancer Res. 2020 Dec;9(12):7716-7724. doi: 10.21037/tcr.2020.04.20. |
| Background | Blumenthal PD, Berek JS. A Practical Guide to Office Gynecologic Procedures. Lippincott Williams & Wilkins; 2013 Apr 8. Chapter 8 |
| Background | Gallos ID, Alazzam M, Clark TJ, Faraj R, Rosenthal AN, Smith PP, Gupta JK. Management of endometrial hyperplasia. Green-top guideline no. 67. RCOG/BSGE Joint Guideline. 2016. |
| 32352730 | Background | Williams PM, Gaddey HL. Endometrial Biopsy: Tips and Pitfalls. Am Fam Physician. 2020 May 1;101(9):551-556. |
| Background | Del Priore G. Office-based endometrial sampling procedures. In: UpToDate, Connor RF (Ed), Wolters Kluwer. (Accessed on November 28, 2024.) |
The above link for inspecting the study protocol and the evidence for a timely study progress. |