Pelvic Organ Prolapse Clinical Trial
Official title:
Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy
Verified date | January 2018 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prior to surgery, gynecologists and urogynecologists have routinely prescribed preoperative
mechanical bowel preparations in attempts to decrease the risk of infection, while also
providing easier bowel manipulation and better visualization during surgery. However, many of
these proposed benefits have never been proven, and usage of bowel preparations amongst
surgeons remains highly variable. In both the general surgery and gynecology literature,
researchers have begun to question the need for the vigorous preparations.
Aside from surgical visualization, urogynecologists have additional concerns about how bowel
preparations may impact postoperative bowel function given up to half of women with pelvic
floor disorders have baseline constipation and straining is known to impact surgical
recovery. Many studies have addressed various postoperative fiber and laxative preparations
in attempts to improve postoperative bowel-related symptomatology, but none have specifically
looked at preoperative bowel preparations.
This study aims to determine if mechanical bowel preparation prior to minimally invasive
sacral colpopexy affects patients' postoperative recovery, specifically related to bowel
symptomatology; operative or post-operative complications; surgeons' perceptions of surgical
difficulty directly attributed to the bowel; and post-operative return of normal bowel
function.
Status | Completed |
Enrollment | 95 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Female - Age = 18 years - Planned laparoscopic or robotic-assisted sacral colpopexy Exclusion Criteria: - History of ulcerative colitis or Crohn's disease - Prior large or small bowel resection - Known diagnosis of gastroparesis - Prior pelvic radiation - History of abdominal or pelvic malignancy - Planned concurrent bowel surgery/anal sphincteroplasty/ rectovaginal fistula repair - Pregnancy - Known allergic reactions to components of the study products - Known renal insufficiency - Non-English speaking as the primary study questionnaires are all currently in English only |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Halina M Zyczynski, MD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PAC-SYM | Bowel symptomatology and bowel-related discomfort will be assessed with the Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM), a 12-item questionnaire covering three domains: abdominal, rectal, and stool. | 1 year | |
Secondary | Surgeon perception of bowel preparation | Immediately after completing the surgical case, surgeons will complete a 13-item surgeon questionnaire assessing degree of surgical difficulty and how it relates to the bowel. Operative time and consultations will also be recorded as objective measures of surgical difficulty. | 1 year | |
Secondary | Return of normal bowel function | A seven-day bowel diary will be obtained at baseline and in the first week after surgery. This log will include daily assessment of bowel frequency, type of bowel movement using the validated Bristol stool scale, degree of straining, and used of narcotics or laxatives. | 1 year | |
Secondary | Perioperative complications | Complications occurring in both groups will be recorded. These include, but are not limited to infections, bowel obstructions, visceral organ injuries, and readmissions. | 1 year |
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