Ignite Creation Date:
2024-05-06 @ 12:55 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01691742
Status:
COMPLETED
Last Update Posted:
2017-02-15
First Post:
2012-09-18
Brief Title:
MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Double-Blind Randomized Controlled Trial of MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery in Women Receiving Routine Docusate Sodium
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MVP
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None