Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2024-11-01
2025-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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Improving technique
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
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
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
FEMALE
No
Sponsors
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Al Adan Hospital Kuwait
INDUSTRY
Cairo University
OTHER
Responsible Party
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Islam Tarek Elkhateb
Dr
Locations
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Adan hospital
Kuwait, Al Ahmadi, Kuwait
Countries
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Blumenthal PD, Berek JS. A Practical Guide to Office Gynecologic Procedures. Lippincott Williams & Wilkins; 2013 Apr 8. Chapter 8
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.
Williams PM, Gaddey HL. Endometrial Biopsy: Tips and Pitfalls. Am Fam Physician. 2020 May 1;101(9):551-556.
Del Priore G. Office-based endometrial sampling procedures. In: UpToDate, Connor RF (Ed), Wolters Kluwer. (Accessed on November 28, 2024.)
Provided Documents
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Document Type: Study Protocol
Study Documents
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Document Type: Study Protocol
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View DocumentOther Identifiers
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QIP2
Identifier Type: -
Identifier Source: org_study_id