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The investigators conduct this prospective study to investigate the learning curve of digital rectal examination (DRE) for prostate cancer among internship. The investigators want to know how many DRE are usually needed for internship to be performed in urological practice to obtain a stable DRE accuracy.
Digital rectal examination (DRE) is a basic physical examination in routine practice in Urology. The DRE is a very important daily practice for screen prostate cancer, and each internship in Urology is required to perform this for patients suspected of prostate cancer or benign prostate hyperplasia. However, how many DRE are usually needed for a internship to perform so as to obtain a stable accuracy in daily practice is currently unknown. The investigators thus conduct this prospective trial to investigate the learning curve of DRE among internship.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | In this group, internship are given the pathology outcome of each prostate biopsy regularly twice a month. |
| |
| Group 2 | In this group, internship are not given the pathology outcome of each prostate biopsy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine review of DRE results by attending doctors | Behavioral | Let the internship regularly compare DRE result and the pathology outcome of prostate biopsy of each patient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of DRE performed by internship will be confirmed by prostate biopsy | To examine the sensitivity and specificity of the DRE performed by internship to reference standard of prostate biopsy in a prospective longitudinal cohort of around 700 participants who will undergo prostate biopsy due to suspect of prostate cancer. The investigators will investigate the sensitivity and specificity of DRE by different internship monthly. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of DRE performed by internship with different training plan will be confirmed by prostate biopsy | To examine the sensitivity and specificity of the DRE performed by internship (group 1 with routinely review of pathologic outcome of prostate biopsy twice a month, and group 2 internship who are not told the results of prostate biopsy) to standard reference of prostate biopsy. |
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Inclusion Criteria:
Exclusion Criteria:
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All included internship are graduated from the Second Military Medical University and have already get the M.D. degree
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuxiong Zeng, M.D., Ph.D | Contact | +86 18930568759 | zengshuxiong@126.com | |
| Xiong Qiao, M.D., Ph.D | Contact | +86 02131161725 | xiongqiao1990@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Chuanliang Xu, M.D., Ph.D | Second Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29061540 | Background | Halpern JA, Oromendia C, Shoag JE, Mittal S, Cosiano MF, Ballman KV, Vickers AJ, Hu JC. Use of Digital Rectal Examination as an Adjunct to Prostate Specific Antigen in the Detection of Clinically Significant Prostate Cancer. J Urol. 2018 Apr;199(4):947-953. doi: 10.1016/j.juro.2017.10.021. Epub 2017 Oct 20. | |
| 28923535 | Background |
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IPD will be shared after the results of the study has been published. Related information will be given if request by email is agreed by the principle investigator.
IPD will be shared after the results of the study has been published.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| One year |
| Sensitivity and specificity of DRE performed by internship will be compared to the results of fPSA/tPSA and MRI. | To compare the sensitivity and specificity of DRE to fPSA/tPSA and MRI (not any patients are required to have MRI examination of prostate, this will be determined at the discretion of attending doctor) to reference standard of prostate biopsy. | One year |
| Clements MB, Schmidt KM, Canfield SE, Gilbert SM, Khandelwal SR, Koontz BF, Lallas CD, Liauw S, Nguyen PL, Showalter TN, Trabulsi EJ, Cathro HP, Schenkman NS, Krupski TL. Creation of a Novel Digital Rectal Examination Evaluation Instrument to Teach and Assess Prostate Examination Proficiency. J Surg Educ. 2018 Mar-Apr;75(2):434-441. doi: 10.1016/j.jsurg.2017.08.012. Epub 2017 Oct 12. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |