Bowel Function After Minimally Invasive Urogynecologic Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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See above

Official Title
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Bowel Function After Minimally Invasive Urogynecologic Surgery: A Prospective Randomized Controlled Trial

Conditions
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Functional Disorder of Intestine

Intervention / Treatment
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* Drug: Docusate
* Drug: Bowel medications


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Docusate<br>Docusate is the standard of care regimen | Drug: Docusate<br>* Docusate 100mg BID<br>* Other names: Colace;|
| Experimental: Bowel medications<br>Docusate, Miralax, Metamucil wafers, Bisacodyl suppository | Drug: Bowel medications<br>* Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID<br>* Other names: Dulcolax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urogynecology