Post Procedural Constipation Clinical Trial
— MVPOfficial title:
Double-Blind Randomized Controlled Trial of MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery in Women Receiving Routine Docusate Sodium
| Verified date | October 2014 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 131 |
| Est. completion date | April 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 19 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Duke University, Department of Urogynecology | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University | American Urogynecologic Society |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to first postoperative bowel movement | 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. | First postoperative week | |
| Secondary | Other postoperative medication use | Rescue laxative use, daily pain level and narcotic use will be obtained from postoperative bowel diaries. | First postoperative week | |
| Secondary | Evaluation of symptoms and quality of life related to constipation | The investigators will evaluate BM quality based upon Bristol stool scale. Straining, abdominal or rectal pain, incomplete evacuation and the impact of these symptoms on GI-related quality of life will be assessed by the PAC-SYM and PAC-QOL validated questionnaires. The PAC-SYM is a validated 12-item questionnaire based upon the Rome criteria for constipation and is tailored to assess a change in symptoms following an intervention.2 This questionnaire has been previously used with success in studies with urogynecologic patients. The PAC-QOL is a validated 28-item questionnaire assessing quality-of-life issues, including burden of constipation on daily functioning and well-being. The Bristol stool scale, which is a visual BM rating scale from 1 to 7, provides a validated measure of gut transit time based upon the shape, consistency and appearance of BM. | First postoperative week | |
| Secondary | Symptoms of Over-Effectiveness | Symptoms of over-effectiveness, including abdominal pain or cramping, bloating, loose stools, watery diarrhea and their impact on GI-related quality of life will be evaluated based upon bowel diaries, Bristol stool scales and the PAC-SYM and PAC-QOL questionnaires. | First Postoperative Week | |
| Secondary | Evaluation of symptoms and quality of life related to constipation 6-weeks postoperatively | The investigators will evaluate BM quality based upon Bristol stool scale. Straining, abdominal or rectal pain, incomplete evacuation and the impact of these symptoms on GI-related quality of life will be assessed by the PAC-SYM and PAC-QOL validated questionnaires. The PAC-SYM is a validated 12-item questionnaire based upon the Rome criteria for constipation and is tailored to assess a change in symptoms following an intervention.2 This questionnaire has been previously used with success in studies with urogynecologic patients. The PAC-QOL is a validated 28-item questionnaire assessing quality-of-life issues, including burden of constipation on daily functioning and well-being. The Bristol stool scale, which is a visual BM rating scale from 1 to 7, provides a validated measure of gut transit time based upon the shape, consistency and appearance of BM. | 5-7 weeks postoperatively |