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

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)

Study Overview

• Status: Completed
• Conditions: Value of the Bowel Preparation and Diet Change Versus no Intervention; Preoperative Bowel Regimen
• Intervention / Treatment: Other: No bowel prep; Other: Clear liquid diet and 2 Fleet's enemas

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham, The Kirklin Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Group A will have no bowel preparation and be permitted a regular diet the day prior to surgery until midnight.	Other: No bowel prep; Participants in this group will have a regular diet and no bowel prep the day prior surgery up until midnight.
Active Comparator: Group B; 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.	Other: Clear liquid diet and 2 Fleet's enemas; Participants in this group will receive a clear liquid diet and 2 Fleets enemas in the late afternoon prior to surgery.; Other Names: Fleets Saline Enema

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeon assessment of bowel preparation	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.	Will be evaluated at 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant experience and acceptance of preoperative bowel management verses no preoperative bowel preparation	Participants will complete a patient assessment/satisfaction questionnaire.	Will be evaluated at 1 year
Bowel Diary and Bristol Stool Scale	Participants will receive 3 seven day bowel diaries,completing one week prior to surgery, and 2 weeks post-operatively. The Bristol Stool Scale is also included as part of the diary and participants are to record each bowel movement during the 3 week period. The information is returned to the physician at the post-operative visit, which occurs approximately 6 weeks after surgery.	Will be evaluated at 1 year
Complications between the two groups	Any complications that arise will be assessed as they occur and the incidence of complications, if any between the two groups, including wound infection (as defined by erythema, purulent material that was treated with antibiotics, re-operation, or drainage), surgical site breakdown, bowel injury or other unintended injury of adjacent anatomy will be assessed after all the procedures are completed.	Will be evaluated at 1 year
Duration of the Case	This relates to the overall operative procedure recorded in total operative time.	Will be evaluated at 1 year
Length of hospital stay	The length of stays will be assessed to gather the average time of stay.	Will be evaluated at 1 year

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Alicia C Ballard, MD, University of Alabama at Birmingham

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 3, 2011
• First Submitted That Met QC Criteria: September 7, 2011
• First Posted (Estimate): September 9, 2011

Study Record Updates

• Last Update Posted (Estimate): June 16, 2014
• Last Update Submitted That Met QC Criteria: June 13, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Bowel Prep; No bowel prep; Vaginal reconstructive or obliterative surgery
• Additional Relevant MeSH Terms: Uterine Diseases; Pathological Conditions, Anatomical; Pelvic Organ Prolapse; Prolapse; Uterine Prolapse
• Other Study ID Numbers: X100928005