Functional Disorder of Intestine
Conditions
Keywords
Urogynecology
Brief summary
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.
Detailed description
See above
Interventions
DRUGDocusate
Docusate 100mg BID
DRUGBowel medications
Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Planning to be admitted to the hospital to undergo minimally-invasive urogynecologic surgery at Strong Memorial Hospital. Procedures may include: * robot-assisted laparoscopic sacrocolpopexy * sacrospinous ligament suspension * uterosacral ligament suspension/paravaginal defect repair * colpocleisis * cystocele repair Additional procedures may include: * hysterectomy * adnexectomy * culdoplasty * minimally invasive sling procedure (TVT or TOT) * periurethral collagen injections * enterocele repair
Exclusion criteria
* Planning to undergo laparotomy. * Undergoing rectocele or perineocele repair as part of surgery. * Taking Miralax, laxatives, enemas, or suppositories daily, at the time of enrollment. * Presence of a colostomy. * Chronic kidney disease * Insulin-dependent diabetes mellitus * Known cardiac disease * Gastric ulcers * Difficulty swallowing or esophageal stricture * Persistent nausea and vomiting * Signs and symptoms consistent with bowel obstruction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Post-op Bowel Movement | Within 1 week of surgery | The time to first post-operative bowel movement was measured in hours after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level Associated With First Postoperative Bowel Movement | Within 1 week of surgery | 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. |
| Consistency of First Postoperative Bowel Movement | Within 1 week of surgery | 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 |
Countries
United States
Participant flow
Recruitment details
Candidates meeting criteria were offered participation at their preoperative visit.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 35 |
| Docusate Controls Docusate is the standard of care regimen
Docusate sodium : Docusate 100mg BID | 37 |
| Total | 72 |
Baseline characteristics
| Characteristic | Docusate Controls | Bowel Medications | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 16 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 19 Participants | 48 Participants |
| Age, Continuous | 63 years STANDARD_DEVIATION 9 | 58 years STANDARD_DEVIATION 10 | 61 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment United States | 37 participants | 35 participants | 72 participants |
| Sex: Female, Male Female | 37 Participants | 35 Participants | 72 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 37 |
| serious Total, serious adverse events | 0 / 35 | 0 / 37 |
Outcome results
Primary
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
Population: Power analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bowel Medications | Time to First Post-op Bowel Movement | 64 hours | Standard Deviation 21 |
| Docusate Controls | Time to First Post-op Bowel Movement | 77 hours | Standard Deviation 24 |
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
Time frame: Within 1 week of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bowel Medications | Consistency of First Postoperative Bowel Movement | 3.13 Bristol Stool Scale | Standard Deviation 1.22 |
| Docusate Controls | Consistency of First Postoperative Bowel Movement | 3.40 Bristol Stool Scale | Standard Deviation 1.07 |
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.
Time frame: Within 1 week of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bowel Medications | Pain Level Associated With First Postoperative Bowel Movement | 3.6 VAS pain score | Standard Deviation 3.2 |
| Docusate Controls | Pain Level Associated With First Postoperative Bowel Movement | 3.7 VAS pain score | Standard Deviation 2.8 |