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This randomized controlled trial was conducted in the Department of Obstetrics and Gynecology, Sheikh Zayed Hospital, Rahim Yar Khan, to compare two commonly used methods for obtaining endometrial tissue in women aged 30 to 60 years presenting with abnormal uterine bleeding. Endometrial sampling is required to identify the underlying cause of abnormal bleeding, including precancerous changes and endometrial cancer. Participants who met eligibility criteria and provided informed consent were allocated to undergo either manual vacuum aspiration or dilatation and curettage. The primary purpose was to determine whether there was a significant difference between the two procedures in obtaining an adequate endometrial sample for histopathological reporting, where adequacy was defined as tissue containing both endometrial glands and stroma in sufficient quantity for interpretation. Pain severity was additionally assessed 24 hours after the procedure using a visual analog scale. The study hypothesis was that a significant difference existed in endometrial sampling adequacy between manual vacuum aspiration and dilatation and curettage among women with abnormal uterine bleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Manual Vacuum Aspiration | Experimental | Performed under paracervical block using 1% xylocaine with adrenaline in an outpatient setting. |
|
| Group Dilatation and Curettage | Active Comparator | Performed under paracervical block using 1% xylocaine with adrenaline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Vacuum Aspiration | Procedure | Endometrial tissue was obtained using a handheld manual vacuum aspirator with appropriately sized cannula (No. 3 to No. 12), generating negative pressure to aspirate tissue from the endometrial cavity for histopathological examination. |
| Measure | Description | Time Frame |
|---|---|---|
| Adequacy of endometrial tissue sample | Adequacy of the endometrial specimen was determined by a consultant histopathologist and defined as the presence of both endometrial glands and stroma in at least 50% of the specimen, with minimal contamination by blood, mucus, or necrotic tissue, and preservation of tissue integrity sufficient for accurate histopathological interpretation. | During the procedure and at the time of histopathological examination of the collected specimen |
| Measure | Description | Time Frame |
|---|---|---|
| Post-procedure pain score | Pain intensity was assessed using the Visual Analog Scale, a 10-centimeter scale ranging from 0 representing no pain to 10 representing the worst pain imaginable. Each participant marked the perceived pain level, and the recorded value was used for analysis. | 24 hours after the endometrial sampling procedure |
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Inclusion Criteria:
Exclusion Criteria:
Females
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| Name | Affiliation | Role |
|---|---|---|
| Afshan Jabeen | Sheikh Zayed Medical college/Hospital, Rahimyar Khan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheikh Zayed Medical college/hospital | Rahim Yar Khan | Punjab Province | 75000 | Pakistan |
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| Dilatation and Curettage | Procedure | The cervix was gradually dilated using cervical dilators, followed by curettage of the endometrial lining with a curette to obtain tissue for histopathological examination. |
|
| ID | Term |
|---|---|
| D008796 | Metrorrhagia |
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D004107 | Dilatation and Curettage |
| ID | Term |
|---|---|
| D003475 | Curettage |
| D013514 | Surgical Procedures, Operative |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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