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Senna vs Dulcolax for Post-Surgery Constipation
N/A
Recruiting
Led By Candace Parker-Autry, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post operative day (pod)1, pod2, pod3, pod4, and pod5
Awards & highlights
No Placebo-Only Group
Summary
This trial will randomly assign women getting surgery for pelvic organ prolapse to either take oral senna or use a rectal bisacodyl suppository after the surgery.
Who is the study for?
This trial is for women aged 18 or older who are scheduled for vaginal surgery to fix pelvic organ prolapse. It's not open to those under 18, unable to consent, using laxatives long-term, or with conditions like inflammatory bowel disease, irritable bowel syndrome, colorectal cancer, fistulas or concurrent bowel surgeries.
What is being tested?
The study compares two methods of managing constipation after vaginal surgery: one group will use oral senna tablets and the other will use rectal bisacodyl suppositories. Women participating will be randomly assigned in equal numbers to either regimen.
What are the potential side effects?
Possible side effects from both senna tablets and bisacodyl suppositories include abdominal pain, diarrhea, nausea and potential irritation at the site of the suppository insertion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post operative day (pod)1, pod2, pod3, pod4, and pod5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post operative day (pod)1, pod2, pod3, pod4, and pod5
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time in hours to first bowel movement comparison between the two arms
Secondary study objectives
Bristol Stool Form Scale (BSFS) Scores
Change in Overall Satisfaction (TSQM) Scores
Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) Scores
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: SENNAExperimental Treatment1 Intervention
Group A participants will be prescribed oral senna (Senokot; Atlantis Consumer Healthcare Inc., Bridgewater, NJ) 8.6mg tablets and be instructed to start with two tablets on the morning of Post Operative Day (POD)#1. Participant will continue taking two tablets on the daily. If no bowel movement on the morning of POD#3 participant may take 2 tablets in the morning and another 2 tablets that evening. The same can be replicated on POD#4. If no bowel movement on the morning of POD#5 participant may take magnesium hydroxide (Phillips' Milk of Magnesia; Bayer AG, Leverkusen, Germany) 30 mL by mouth and need to call the urology clinic for further instruction.
Group II: DULCOLAXExperimental Treatment1 Intervention
Group B participants will be prescribed bisacodyl rectal (Dulcolax Suppository; Sanofi S.A., Paris, France) 1 suppository to be placed rectally on the morning of Post Operative Day (POD)#1. Participant will continue placing a nightly rectal suppository until their first bowel movement. If no bowel movement by the morning of POD#5 participant may take magnesium hydroxide (Phillips' Milk of Magnesia; Bayer AG, Leverkusen, Germany) 30 mL by mouth and need to call the clinic for further instruction.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,401 Previous Clinical Trials
2,460,217 Total Patients Enrolled
1 Trials studying Constipation
12 Patients Enrolled for Constipation
Candace Parker-Autry, MDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
144 Total Patients Enrolled