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The study aimed to compare the use of a transurethral laparoscope to the use of a traditional cystoscope for evaluation of the bladder and ureters at the time of laparoscopic hysterectomy. The hypothesis was that visual inspection of the bladder and ureters can be done safely using a transurethral laparoscope, takes less time than traditional cystoscopy, and is more cost effective than traditional cystoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transurethral laparoscope | Experimental | These patients had cystoscopy performed with the transurethral laparoscope. |
|
| Traditional cystoscopy | Active Comparator | These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard." |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cystoscopy | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time Required to Perform Procedure (in Seconds) | Time required to perform cystoscopy with a laparoscope or a cystoscope after laparoscopic hysterectomy. | During Procedure (Up to 15 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Kratz, M.D. | AdventHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital | Winter Park and Celebration | Florida | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22818539 | Derived | Kratz KG, Spytek SH, Caceres A, Lukman R, McCarus SD. A randomized, single-blinded pilot study evaluating use of a laparoscope or a cystoscope for cystoscopy during gynecologic surgery. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):606-14. doi: 10.1016/j.jmig.2012.06.002. Epub 2012 Jul 17. |
| Label | URL |
|---|---|
| Publication of study | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transurethral Laparoscope | These patients had cystoscopy performed with the transurethral laparoscope. |
| FG001 | Traditional Cystoscopy | These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard." |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transurethral Laparoscope | These patients had cystoscopy performed with the transurethral laparoscope. cystoscopy |
| BG001 | Traditional Cystoscopy | These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard." cystoscopy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time Required to Perform Procedure (in Seconds) | Time required to perform cystoscopy with a laparoscope or a cystoscope after laparoscopic hysterectomy. | Posted | Mean | 95% Confidence Interval | seconds | During Procedure (Up to 15 minutes) |
|
Adverse event data was collected for the duration of the study January-July 2009, and up to 6 weeks after the surgical intervention for each subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transurethral Laparoscope | These patients had cystoscopy performed with the transurethral laparoscope. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bladder discomfort/pain | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Kratz, M.D. | Florida Hospital | katiegoodrich@gmail.com |
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| ID | Term |
|---|---|
| D003558 | Cystoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Smoker (%) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 1 |
| 33 |
| EG001 | Traditional Cystoscopy | These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard." | 0 | 33 | 0 | 33 | 6 | 33 |
| hematoma | Renal and urinary disorders | Systematic Assessment |
|
| Postoperative Urinary Tract Infection (UTI) | Renal and urinary disorders | Systematic Assessment |
|
| Vaginal bleed | Reproductive system and breast disorders | Systematic Assessment |
|
| Trocar-site bleed | Surgical and medical procedures | Systematic Assessment |
|
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| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |