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NCT01691742 · ClinicalTrials.gov registry record · NA
MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 131
- Enrollment target
NCT01691742: Completed NA study, sponsored by Duke University.
NCT01691742 is a NA study that has completed, run by Duke University. The registered enrollment target is 131 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01691742, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 131 participants
- Enrollment target
Study 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.
Primary Outcome
The primary outcome is time to first postoperative bowel movement (in hours, converted to days) based upon postoperative bowel diary. Time will be calculated based upon date and time of first postoperative bowel movement from start time of surgery.
Interventions
- DRUG Placebo
- DRUG MiraLax
- DRUG Rescue Laxative
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-04 |
| Phase | NA |
What the finished NCT01691742 record still lists
NCT01691742 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01691742 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01691742 about?
NCT01691742 is a clinical study titled "MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery". 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 MiraLA...
What is the current status of trial NCT01691742?
This trial is currently completed. It is a NA study. The enrollment target is 131 participants. The study started on 2012-09. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01691742?
The interventions under investigation include: Placebo (DRUG), MiraLax (DRUG), Rescue Laxative (DRUG).
Who is sponsoring clinical trial NCT01691742?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01691742's enrollment target sits among peer trials
131 732nd of 2000 higher than 1,268 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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