Patient Experience and Bowel Preparation for Transvaginal Surgical Management of Vaginal Prolapse



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:January 2011
End Date:December 2012
Contact:Alice Howell, RN
Email:howella@uab.edu
Phone:(205) 975-8592

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Preoperative bowel preparation for surgical management of pelvic floor disorders is
performed inconsistently, and includes no prep, the use of dietary changes or bowel altering
interventions. Retrospective studies of emergency colonic surgery first demonstrated a low
rate of infectious complications without a bowel prep. Recently, data supporting the routine
use of mechanical cleansing for elective colorectal surgery has demonstrated the surgical
outcomes are similar between patients that undergo a bowel preparation versus those that do
not, indicating that the long held dogma of mechanical bowel preparation should be used
selectively. Despite routine use, there is a paucity of literature addressing the approach
to, and/or need for preoperative bowel management at the time of vaginal reconstructive or
obliterative surgery. The majority of the pelvic floor disorder population is older, tending
to have more bowel dysfunction (especially symptoms of constipation) than younger women.

The aim of this study is to evaluate preoperative bowel management strategy as it relates to
the total care of the vaginal surgery patients' intra-and post-operative bowel function and
overall patient experience. Two commonly used pre-operative bowel prep strategies: no
preoperative bowel prep versus clear fluids and 2-enema prep. The aim is to assess the value
of bowel preparation or diet change in vaginal surgery, both from the physician's and
patient's point of view. In this pilot study, subjects are randomized to either a clear
liquid diet the day prior to surgery with 2 enemas and nothing by mouth (NPO) after
midnight, or NPO after midnight without any dietary changes or enemas.

Our aims are:

*Primary - To assess the surgeons' objective intraoperative evaluation of the effects of
bowel preparation (adequate visualization, stooling during case, difficulty with bowel
handling) *Secondary - (1)To characterize the patients' experience and acceptance of
preoperative bowel management regimen versus no preoperative bowel preparation(2) To
characterize the patients' postoperative experience and determine if the preoperative bowel
regimen affects time to first bowel movement/first normal stool as well as stool experience
as recorded by bowel diary (3)Evaluate the incidence of complications between the two groups
(4)Characterize other descriptive qualities of the patients' operative experience(duration
of case, length of hospital stay)


Inclusion Criteria:

- Age ≥ 19

- Female

- Undergoing transvaginal reconstructive surgical intervention for vaginal prolapse
(apical suspension and posterior compartment repair required, other concurrent
surgery allowed)

Exclusion Criteria:

- Male

- Pregnant, planning pregnancy, or less than 1 year from delivery

- History of total colectomy or prior ileostomy

- Inflammatory bowel disorder (Crohn's disease and ulcerative colitis) formally
diagnosed

- Inability to understand written study material (including non-English speaking)

- Inability to give consent

- Presently diagnosed colorectal cancer

- Undergoing chemotherapy and/or radiation

- Chronic constipation suggestive of colonic inertia defined as fewer that 3 stools per
week (Rome III guidelines)

- Severe neurological diseases (such as Multiple Sclerosis)
We found this trial at
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Birmingham, AL
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