MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery
Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post Procedural Constipation
Intervention: MiraLax (Drug); Placebo (Drug); Rescue Laxative (Drug)
Phase: N/A
Status: Completed
Sponsored by: Duke University Official(s) and/or principal investigator(s): Anthony G Visco, MD, Principal Investigator, Affiliation: Duke University
Summary
A. Purpose To compare MiraLAX versus placebo for preventing constipation in the immediate
postoperative period following pelvic reconstructive surgery in women taking routine
docusate sodium.
B. Objectives
1. Specific Aims Specific Aim 1: To compare time to first bowel movement (BM) between
MiraLAX versus placebo in women receiving routine docusate sodium after pelvic
reconstructive surgery.
Specific Aim 2: To compare patient reported outcomes of BM quality and associated
gastrointestinal (GI) symptoms between MiraLAX versus placebo using the Bristol stool
scale and the validated Patient Assessment of Constipation Symptom Questionnaire
(PAC-SYM) in women receiving routine docusate sodium after pelvic reconstructive
surgery.
Specific Aim 3: To evaluate GI-related quality of life between MiraLAX versus placebo
utilizing the validated Patient Assessment of Constipation Quality-of-Life
Questionnaire (PAC-QOL) in women receiving routine docusate sodium after pelvic
reconstructive surgery.
2. Hypotheses The investigators hypothesize that MiraLAX will optimally prevent
constipation following pelvic reconstructive surgery by decreasing time to first BM,
decreasing GI symptoms associated with constipation, and increasing measures of
GI-related quality of life, while minimizing the bothersome side effects associated
with stimulant laxatives.
Clinical Details
Official title: Double-Blind Randomized Controlled Trial of MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery in Women Receiving Routine Docusate Sodium
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Time to first postoperative bowel movement
Secondary outcome: Other postoperative medication useEvaluation of symptoms and quality of life related to constipation Symptoms of Over-Effectiveness Evaluation of symptoms and quality of life related to constipation 6-weeks postoperatively
Detailed description:
This is a randomized double-blind placebo-controlled clinical trial of MiraLAX versus
placebo in women undergoing pelvic reconstructive surgery receiving routine docusate sodium.
Subjects will be screened for eligibility during their preoperative visits and once
enrolled, they will be randomized to receive MiraLAX or placebo starting on postoperative
day (POD) 1 and continuing through POD 5. Subjects will be instructed to stop taking this
medication if they experience any diarrhea. Subjects in both arms will be instructed to
take milk of magnesia as a rescue laxative if they do not experience a BM by the morning of
POD 6. All subjects will be provided a 30 day supply of docusate sodium and be instructed
to begin this medication on POD 1.
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- English-speaking female patients
- > 18 years of age
- Not pregnant (patients of childbearing potential will have a serum pregnancy test
done pre-operatively as part of their surgical planning)
- Undergoing surgery for pelvic organ prolapse or stress urinary incontinence
- Recruited from the Duke University Division of Urogynecology
Exclusion Criteria:
- Allergy/hypersensitivity to study medications
- Cardiac or renal disease
- Takes chronic daily laxatives
- Excluded if unable to complete at least 5 days of a 7 day baseline bowel diary
- Excluded if mesh resection or Interstim procedure
- Excluded if concurrent surgery includes anal sphincteroplasty or rectovaginal fistula
repair
Locations and Contacts
Duke University, Department of Urogynecology, Durham, North Carolina 27707, United States
Additional Information
Starting date: September 2012
Last updated: May 15, 2015
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