MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery
| Status: | Completed |
|---|---|
| Conditions: | Constipation |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 2/16/2017 |
| Start Date: | September 2012 |
| End Date: | April 2015 |
Double-Blind Randomized Controlled Trial of MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery in Women Receiving Routine Docusate Sodium
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.
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.
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.
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.
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
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