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

NCT01431040 | Completed

• 1 other identifier: X100928005
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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)

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Other: No bowel prep

Group B

ACTIVE COMPARATOR

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

Interventions

No bowel prep OTHER

Participants in this group will have a regular diet and no bowel prep the day prior surgery up until midnight.

Group A

Clear liquid diet and 2 Fleet's enemas OTHER

Participants in this group will receive a clear liquid diet and 2 Fleets enemas in the late afternoon prior to surgery.

Also known as: Fleets Saline Enema

Group B

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 19
• Female
• Undergoing transvaginal reconstructive surgical intervention for vaginal prolapse (apical suspension and posterior compartment repair required, other concurrent surgery allowed)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham, The Kirklin Clinic

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• 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.

  PMID: 24402594 DERIVED

Study Officials

• Alicia C Ballard, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: September 9, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2013
• Last Updated: June 16, 2014

Record last verified: 2014-06

Locations

US (1)