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The purpose of this study is to assess the effect of a standardized postoperative bowel regimen of over-the-counter medications in subjects undergoing minimally invasive urogynecologic surgery.
See above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docusate | Active Comparator | Docusate is the standard of care regimen |
|
| Bowel medications | Experimental | Docusate, Miralax, Metamucil wafers, Bisacodyl suppository |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docusate | Drug | Docusate 100mg BID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Post-op Bowel Movement | The time to first post-operative bowel movement was measured in hours after surgery. | Within 1 week of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Level Associated With First Postoperative Bowel Movement | The pain level experienced with the first post-operative bowel movement was recorded and measured on visual analog score with range 0 to 10 in units on scale. 0 being no pain at all. 10 being worst pain. | Within 1 week of surgery |
| Consistency of First Postoperative Bowel Movement |
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Inclusion Criteria:
Procedures may include:
Additional procedures may include:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunhilde Buchsbaum, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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Candidates meeting criteria were offered participation at their preoperative visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bowel Medications | Docusate, Miralax, Metamucil wafers, Bisacodyl suppository Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID |
| FG001 | Docusate Controls | Docusate is the standard of care regimen Docusate sodium : Docusate 100mg BID |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bowel Medications | Docusate, Miralax, Metamucil wafers, Bisacodyl suppository Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID |
| BG001 | Docusate Controls |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 to First Post-op Bowel Movement | The time to first post-operative bowel movement was measured in hours after surgery. | Power analysis | Posted | Mean | Standard Deviation | hours | Within 1 week of surgery |
|
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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 | Bowel Medications | Docusate, Miralax, Metamucil wafers, Bisacodyl suppository Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gunhilde Buchsbaum, Division Director Urogynecology | University of Rochester | 585-273-3233 | gunhilde_buchsbaum@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D004143 | Dioctyl Sulfosuccinic Acid |
| D011620 | Psyllium |
| D011092 | Polyethylene Glycols |
| D001726 | Bisacodyl |
| ID | Term |
|---|---|
| D013386 | Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Bowel medications |
| Drug |
Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID |
|
|
The consistency of the first post-operative bowel movement was rated using the Bristol Stool Scale. This is a validated scale that is widely used. It is given to patients as a chart. The chart can be seen here: http://en.wikipedia.org/wiki/Bristol\_stool\_scale. The seven types of stool are: Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid |
| Within 1 week of surgery |
Docusate is the standard of care regimen Docusate sodium : Docusate 100mg BID |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Pain Level Associated With First Postoperative Bowel Movement | The pain level experienced with the first post-operative bowel movement was recorded and measured on visual analog score with range 0 to 10 in units on scale. 0 being no pain at all. 10 being worst pain. | Posted | Mean | Standard Deviation | VAS pain score | Within 1 week of surgery |
|
|
|
| Secondary | Consistency of First Postoperative Bowel Movement | The consistency of the first post-operative bowel movement was rated using the Bristol Stool Scale. This is a validated scale that is widely used. It is given to patients as a chart. The chart can be seen here: http://en.wikipedia.org/wiki/Bristol\_stool\_scale. The seven types of stool are: Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid | Posted | Mean | Standard Deviation | Bristol Stool Scale | Within 1 week of surgery |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Docusate Controls | Docusate is the standard of care regimen Docusate sodium : Docusate 100mg BID | 0 | 37 | 0 | 37 |
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| D009930 |
| Organic Chemicals |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D003408 | Cresols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |