Patient Experience and Bowel Preparation for Transvaginal Surgical Management of Vaginal Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Surgeon assessment of bowel preparation
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Undergoing transvaginal reconstructive surgical intervention for vaginal prolapse (apical suspension and posterior compartment repair required, other concurrent surgery allowed)
排除标准
- •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)
结局指标
主要结局
Surgeon assessment of bowel preparation
时间窗: Will be evaluated at 1 year
The primary outcome measure will be measured using the surgeon satisfaction questionnaire which is filled out immediately post-op. The surgeon assessment of the bowel preparation and its potential outcome on the surgical field (adequate visualization, stooling during case, and difficulty with bowel handling) will be measured.
次要结局
- Participant experience and acceptance of preoperative bowel management verses no preoperative bowel preparation(Will be evaluated at 1 year)
- Bowel Diary and Bristol Stool Scale(Will be evaluated at 1 year)
- Complications between the two groups(Will be evaluated at 1 year)
- Duration of the Case(Will be evaluated at 1 year)
- Length of hospital stay(Will be evaluated at 1 year)
研究者
Alicia Ballard
M.D.
University of Alabama at Birmingham