Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335797
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-03-22
Brief Title:
Optimization of Postoperative Bowel Habits
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Optimization of Postoperative Bowel Habits Following Pelvic Reconstructive Surgery a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
Project is a trial in which women undergoing vaginal surgery for pelvic organ prolapse will be randomized 11 to a postoperative bowel regimen of either oral senna or rectal bisacodyl suppository
Detailed Description:
Delayed return to bowel function following vaginal surgery for pelvic organ prolapse has been deemed to be highly distressing for patients and is ranked as one of the most common reasons for emergency department visits and telephone calls in the immediate post-operative period
Despite the prevalence of constipation and significant effect on quality of life few studies have examined an evidence-based bowel regimen for postoperative constipation prevention in the Urogynecology population
As per available medical literature the onset of action for oral senna occurs within 6-12 hours while bisacodyl suppository can take effect between 15 and 60 minutes following rectal administration Proposed trial comparing oral senna to rectal bisacodyl suppositories for the prevention of postoperative constipation in women undergoing vaginal reconstructive surgery for symptomatic prolapse
Despite the prevalence of constipation and significant effect on quality of life few studies have examined an evidence-based bowel regimen for postoperative constipation prevention in the Urogynecology population
As per available medical literature the onset of action for oral senna occurs within 6-12 hours while bisacodyl suppository can take effect between 15 and 60 minutes following rectal administration Proposed trial comparing oral senna to rectal bisacodyl suppositories for the prevention of postoperative constipation in women undergoing vaginal reconstructive surgery for symptomatic prolapse
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?:
True
Is an FDA AA801 Violation?:
None