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

Tracking Information
First Submitted Date ICMJE	August 3, 2011
First Posted Date ICMJE	September 9, 2011
Last Update Posted Date	June 16, 2014
Study Start Date ICMJE	January 2011
Actual Primary Completion Date	August 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 7, 2011)	Surgeon assessment of bowel preparation [ Time Frame: 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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01431040 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 7, 2011)	Participant experience and acceptance of preoperative bowel management verses no preoperative bowel preparation [ Time Frame: Will be evaluated at 1 year ]Participants will complete a patient assessment/satisfaction questionnaire.; Bowel Diary and Bristol Stool Scale [ Time Frame: Will be evaluated at 1 year ]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.; Complications between the two groups [ Time Frame: Will be evaluated at 1 year ]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.; Duration of the Case [ Time Frame: Will be evaluated at 1 year ]This relates to the overall operative procedure recorded in total operative time.; Length of hospital stay [ Time Frame: Will be evaluated at 1 year ]The length of stays will be assessed to gather the average time of stay.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Patient Experience and Bowel Preparation for Transvaginal Surgical Management of Vaginal Prolapse
Official Title ICMJE	Patient Experience and Bowel Preparation for Transvaginal Surgical Management of Vaginal Prolapse
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)
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label)
Condition ICMJE	Value of the Bowel Preparation and Diet Change Versus no Intervention; Preoperative Bowel Regimen
Intervention ICMJE	Other: No bowel prep Participants in this group will have a regular diet and no bowel prep the day prior surgery up until 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 Name: Fleets Saline Enema
Study Arms	Active Comparator: Group A Group A will have no bowel preparation and be permitted a regular diet the day prior to surgery until midnight. Intervention: Other: No bowel prep; 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. Intervention: Other: Clear liquid diet and 2 Fleet's enemas
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):232-8. doi: 10.1097/AOG.0000000000000081.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 13, 2014)	150
Original Estimated Enrollment ICMJE; (submitted: September 7, 2011)	160
Actual Study Completion Date	August 2013
Actual Primary Completion Date	August 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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)
Sex/Gender	Sexes Eligible for Study: Female
Ages	19 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01431040
Other Study ID Numbers ICMJE	X100928005
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Alicia Ballard, University of Alabama at Birmingham
Study Sponsor ICMJE	University of Alabama at Birmingham
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Alicia C Ballard, MD University of Alabama at Birmingham
PRS Account	University of Alabama at Birmingham
Verification Date	June 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP