Clinical trial NCT01431040: Patient Experience and Bowel Preparation for Transvaginal Surgical Management of Vaginal Prolapse
Official title: Patient Experience and Bowel Preparation for Transvaginal Surgical Management of Vaginal Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Value of the Bowel Preparation and Diet Change Versus no Intervention
Preoperative Bowel Regimen
Keywords: Bowel Prep
No bowel prep
Vaginal reconstructive or obliterative surgery
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2011-09-09
Enrollment: 150
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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)


Eligibility criteria: 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)

Primary outcomes:
measure: Surgeon assessment of bowel preparation
timeFrame: Will be evaluated at 1 year
Secondary outcomes:
measure: Participant experience and acceptance of preoperative bowel management verses no preoperative bowel preparation
timeFrame: Will be evaluated at 1 year
measure: Bowel Diary and Bristol Stool Scale
timeFrame: Will be evaluated at 1 year
measure: Complications between the two groups
timeFrame: Will be evaluated at 1 year
measure: Duration of the Case
timeFrame: Will be evaluated at 1 year
measure: Length of hospital stay
timeFrame: Will be evaluated at 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, The Kirklin Clinic
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Alicia C Ballard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ballard AC, Parker-Autry CY, Markland AD, Varner RE, Huisingh C, Richter HE. Bowel preparation before vaginal prolapse surgery: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):232-238. doi: 10.1097/AOG.0000000000000081.