An interventional study of Docusate and Bowel medications in Functional Disorder of Intestine, sponsored by University of Rochester. Completed at 1 site in United States. Open to female participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-21.
Sponsored by University of Rochester · Not applicable, Interventional, and Prevention
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.
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963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's enrollment of 72 is close to the median of 70 across 552 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
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Procedures may include:
Additional procedures may include:
Exclusion Criteria:
Docusate is the standard of care regimen
Drug: Docusate
Docusate, Miralax, Metamucil wafers, Bisacodyl suppository
Drug: Bowel medications
Docusate 100mg BID
Also known as: Colace
Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID
Also known as: Colace, Psyllium, Polyethylene glycol, Dulcolax
Time to First Post-op Bowel Movement
The time to first post-operative bowel movement was measured in hours after surgery.
Time frame: Within 1 week of surgery
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.
Time frame: Within 1 week of surgery
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
Time frame: Within 1 week of surgery
Candidates meeting criteria were offered participation at their preoperative visit.
| Milestone | Bowel Medications | Docusate Controls |
|---|---|---|
| Started | 35 | 37 |
| Completed | 30 | 30 |
| Not completed | 5 | 7 |
The time to first post-operative bowel movement was measured in hours after surgery.
| hours | Bowel Medications | Docusate Controls |
|---|---|---|
| Time to First Post-op Bowel Movement | 64 ± 21 | 77 ± 24 |
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.
| VAS pain score | Bowel Medications | Docusate Controls |
|---|---|---|
| Pain Level Associated With First Postoperative Bowel Movement | 3.6 ± 3.2 | 3.7 ± 2.8 |
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
| Bristol Stool Scale | Bowel Medications | Docusate Controls |
|---|---|---|
| Consistency of First Postoperative Bowel Movement | 3.13 ± 1.22 | 3.40 ± 1.07 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bowel Medications | — | 0/35 (0%) | 0/35 (0%) |
| Docusate Controls | — | 0/37 (0%) | 0/37 (0%) |
| Age, Categorical(Participants) | Bowel Medications | Docusate Controls | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 19 | 29 | 48 |
| >=65 years | 16 | 8 | 24 |
| Age, Continuous(years) | Bowel Medications | Docusate Controls | Total |
|---|---|---|---|
| Mean | 58 ± 10 | 63 ± 9 | 61 ± 9.5 |
| Sex: Female, Male(Participants) | Bowel Medications | Docusate Controls | Total |
|---|---|---|---|
| Female | 35 | 37 | 72 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Bowel Medications | Docusate Controls | Total |
|---|---|---|---|
| United States | 35 | 37 | 72 |
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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