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

The University of Alabama at Birmingham

Status: Completed

Conditions: Value of the Bowel Preparation and Diet Change Versus no Intervention; Preoperative Bowel Regimen

Treatments: Other: No bowel prep; Other: Clear liquid diet and 2 Fleet's enemas

Study type: Interventional

Funder types: Other

Identifiers

NCT01431040

X100928005

Details and patient eligibility

About

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)

Enrollment: 150 patients

Sex: Female

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

150 participants in 2 patient groups

Group A

Active Comparator group

Description:

Group A will have no bowel preparation and be permitted a regular diet the day prior to surgery until midnight.

Treatment:

Other: No bowel prep

Group B

Active Comparator group

Description:

Participants in this group will consume a clear liquid diet and perform 2 Fleets enemas in the late afternoon the day before surgery and nothing after midnight.

Treatment:

Other: Clear liquid diet and 2 Fleet's enemas