Post Procedural Constipation Clinical Trial
Official title:
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.
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. ;