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Objective:
The investigators seek to compare the efficiency of the cystoscopy with two interventions:
This is a randomized controlled trial assessing time to completion of cystoscopy in seconds after minimally invasive gynecologic surgery.
The investigators seek to compare the efficiency of the cystoscopy with two interventions:
Both interventions are used as usual care and depend on surgeon preference without evidence why one would be faster at completing the cystoscopy. Also note that these two interventions are performed multiple times during the surgery itself and outside the cystoscopy procedure routinely. The investigator's main objective is to assess which intervention or combination of interventions is more efficient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flat position with no Insufflation | Experimental |
| |
| Trendelenburg position and Insufflation | Experimental | insufflation to 15 mm Hg |
|
| Flat position and Insufflation | Experimental |
| |
| Trendelenburg position with no Insufflation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flat position | Other | Flat patient position during the cystoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time in Seconds to Complete the Cystourethroscopy | Time in seconds to satisfactorily complete the cystourethroscopy (including visualization of the dome, the ureteral jets, the bladder mucosa, and the urethra). | From the start of the cystoscopy to the completion of the cystoscopy (about 4 minutes) |
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Inclusion Criteria:
- Patient undergoing Planned cystoscopy in the benign gynecology service, (specifically undergoing a laparoscopic or robotic procedure requiring insufflation).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randa Jalloul, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Flat Position With no Insufflation | Flat position: Flat patient position during the cystoscopy |
| FG001 | Trendelenburg Position and Insufflation | insufflation to 15 mm Hg Trendelenburg position: Trendelenburg position (head down) during the cystoscopy Insufflation: Insufflation to 15 mm Hg |
| FG002 | Flat Position and Insufflation | Flat position: Flat patient position during the cystoscopy Insufflation: Insufflation to 15 mm Hg |
| FG003 | Trendelenburg Position With no Insufflation | Trendelenburg position: Trendelenburg position (head down) during the cystoscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Flat Position With no Insufflation | Flat position: Flat patient position during the cystoscopy |
| BG001 | Trendelenburg Position and Insufflation | insufflation to 15 mm Hg Trendelenburg position: Trendelenburg position (head down) during the cystoscopy Insufflation: Insufflation to 15 mm Hg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 in Seconds to Complete the Cystourethroscopy | Time in seconds to satisfactorily complete the cystourethroscopy (including visualization of the dome, the ureteral jets, the bladder mucosa, and the urethra). | Posted | Median | Inter-Quartile Range | seconds | From the start of the cystoscopy to the completion of the cystoscopy (about 4 minutes) |
|
6 weeks
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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 | Flat Position With no Insufflation | Flat position: Flat patient position during the cystoscopy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Systematic Assessment | Adverse event is not related to intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randa J Jalloul, MD | The University of Texas Health Science Center at Houston | 713-566-5749 | Randa.J.Jalloul@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2023 | Jan 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018475 | Head-Down Tilt |
| D007327 | Insufflation |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D019937 | Diagnostic Techniques and Procedures |
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| Trendelenburg position | Other | Trendelenburg position (head down) during the cystoscopy |
|
| Insufflation | Device | Insufflation to 15 mm Hg |
|
| BG002 | Flat Position and Insufflation | Flat position: Flat patient position during the cystoscopy Insufflation: Insufflation to 15 mm Hg |
| BG003 | Trendelenburg Position With no Insufflation | Trendelenburg position: Trendelenburg position (head down) during the cystoscopy |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of participants with Diabetes | Count of Participants | Participants |
|
| Number of participants with hypertension | Count of Participants | Participants |
|
| Number of participants who smoke | Count of Participants | Participants |
|
| Number of participants with hyperlipidemia | Count of Participants | Participants |
|
| Number of participants with heart disease | Count of Participants | Participants |
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| Number of participants with lung disease | Count of Participants | Participants |
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| Number of Participants with history of previous abdominal surgery | Count of Participants | Participants |
|
| Parity | number of completed pregnancies beyond 20 weeks gestation (whether viable or nonviable) | Count of Participants | Participants |
|
| Level of Creatinine | Data were not collected for 1 participant in the Trendelenburg position and Insufflation arm. | Median | Inter-Quartile Range | milligrams per deciliter |
|
| Hemoglobin level at admission | Median | Inter-Quartile Range | grams per deciliter |
|
| Hemoglobin A1c (HbA1c) at Pre-operation | Data were not collected for 25 participants in the Flat position with no Insufflation arm. Data were not collected for 25 participants in the Trendelenburg position and Insufflation arm. Data were not collected for 25 participants in the Flat position and Insufflation arm. Data were not collected for 23 participants in the Trendelenburg position with no Insufflation arm. | Median | Inter-Quartile Range | percentage of HbA1c |
|
| Glomerular Filtration Rate (GFR) at admission | Data were not collected for 1 participant in the Trendelenburg position and Insufflation arm. | Median | Inter-Quartile Range | milliliters per minutes |
|
| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
| OG002 | Flat Position and Insufflation | Flat position: Flat patient position during the cystoscopy Insufflation: Insufflation to 15 mm Hg |
| OG003 | Trendelenburg Position With no Insufflation | Trendelenburg position: Trendelenburg position (head down) during the cystoscopy |
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 1 |
| 31 |
| EG001 | Trendelenburg Position and Insufflation | insufflation to 15 mm Hg Trendelenburg position: Trendelenburg position (head down) during the cystoscopy Insufflation: Insufflation to 15 mm Hg | 0 | 30 | 0 | 30 | 2 | 30 |
| EG002 | Flat Position and Insufflation | Flat position: Flat patient position during the cystoscopy Insufflation: Insufflation to 15 mm Hg | 0 | 30 | 0 | 30 | 1 | 30 |
| EG003 | Trendelenburg Position With no Insufflation | Trendelenburg position: Trendelenburg position (head down) during the cystoscopy | 0 | 31 | 0 | 31 | 0 | 31 |
|
| Fall | General disorders | Systematic Assessment | Adverse event is not related to intervention. |
|
| Post-Operation abdominal pain | General disorders | Systematic Assessment | Adverse event is not related to intervention. |
|
| Vaginal Bleeding | General disorders | Systematic Assessment | Adverse event is not related to intervention. |
|
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| D003933 | Diagnosis |
| D013812 | Therapeutics |
| Male |
|
| Other (non-Caucasian) |
|
| 1 or more |
|