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

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ClinicalTrials.gov Identifier: NCT01431040
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : June 16, 2014
Information provided by (Responsible Party):

Study Description
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)

Condition or disease Intervention/treatment
Value of the Bowel Preparation and Diet Change Versus no Intervention Preoperative Bowel Regimen Other: No bowel prep Other: Clear liquid diet and 2 Fleet's enemas

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Patient Experience and Bowel Preparation for Transvaginal Surgical Management of Vaginal Prolapse
Study Start Date : January 2011
Primary Completion Date : August 2012
Study Completion Date : August 2013
Arms and Interventions

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 Name: Fleets Saline Enema

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Duration of the Case [ Time Frame: Will be evaluated at 1 year ]
    This relates to the overall operative procedure recorded in total operative time.

  5. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431040

United States, Alabama
University of Alabama at Birmingham, The Kirklin Clinic
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Principal Investigator: Alicia C Ballard, MD University of Alabama at Birmingham
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alicia Ballard, M.D., University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01431040     History of Changes
Other Study ID Numbers: X100928005
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: June 2014

Keywords provided by Alicia Ballard, University of Alabama at Birmingham:
Bowel Prep
No bowel prep
Vaginal reconstructive or obliterative surgery

Additional relevant MeSH terms:
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse