Value of the Bowel Preparation and Diet Change Versus no InterventionNCT01431040
Patient Experience and Bowel Preparation for Transvaginal Surgical Management of Vaginal Prolapse
A study testing No bowel prep and Clear liquid diet and 2 Fleet's enemas in people with Value of the Bowel Preparation and Diet Change Versus no Intervention and Preoperative Bowel Regimen, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Value of the Bowel Preparation and Diet Change Versus no Intervention, Preoperative Bowel Regimen
- What is being tested?
- No bowel prep and Clear liquid diet and 2 Fleet's enemas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 19
- Female
- Undergoing transvaginal reconstructive surgical intervention for vaginal prolapse (apical suspension and posterior compartment repair required, other concurrent surgery allowed)
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham, The Kirklin Clinic
Birmingham, Alabama, 35233
About this study
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.
Read more
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
- Being tested
- No bowel prep, Clear liquid diet and 2 Fleet's enemas
- Keywords
- Bowel Prep, No bowel prep, Vaginal reconstructive or obliterative surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No bowel prepOther
Participants in this group will have a regular diet and no bowel prep the day prior surgery up until midnight.
Clear liquid diet and 2 Fleet's enemasOther
Also called Fleets Saline Enema
Participants in this group will receive a clear liquid diet and 2 Fleets enemas in the late afternoon prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A will have no bowel preparation and be permitted a regular diet the day prior to surgery until midnight. Receives: 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. Receives: Other: Clear liquid diet and 2 Fleet's enemas |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Will be evaluated at 1 year
Secondary outcomes (5)
Participant experience and acceptance of preoperative bowel management verses no preoperative bowel preparation
Participants will complete a patient assessment/satisfaction questionnaire.
Measured: 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.
Measured: 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.
Measured: Will be evaluated at 1 year
Duration of the Case
This relates to the overall operative procedure recorded in total operative time.
Measured: Will be evaluated at 1 year
Length of hospital stay
The length of stays will be assessed to gather the average time of stay.
Measured: Will be evaluated at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Value of the Bowel Preparation and Diet Change Versus no InterventionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alicia Ballard, University of Alabama at Birmingham
- Investigators
- Alicia C Ballard, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431040
- Sponsor's protocol ID
- X100928005
- Status last verified
- Jun 2014
- First submitted
- 3 Aug 2011
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24402594
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Experience and Bowel Preparation for Transvaginal Surgical Management of Vaginal Prolapse
- ClinicalTrials.gov ID
- NCT01431040
- Acronym / sponsor ID
- X100928005
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 9 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: No bowel prepGroup A will have no bowel preparation and be permitted a regular diet the day prior to surgery until midnight. |
| Group B | Active comparator | Other: Clear liquid diet and 2 Fleet's enemasParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 19
- Female
- Undergoing transvaginal reconstructive surgical intervention for vaginal prolapse (apical suspension and posterior compartment repair required, other concurrent surgery allowed)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No bowel prepParticipants in this group will have a regular diet and no bowel prep the day prior surgery up until midnight. | Other | Group A |
| Clear liquid diet and 2 Fleet's enemasAlso: Fleets Saline EnemaParticipants in this group will receive a clear liquid diet and 2 Fleets enemas in the late afternoon prior to surgery. | Other | Group B |
Primary outcome
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.
5 secondary outcomes
Participant experience and acceptance of preoperative bowel management verses no preoperative bowel preparation
Time frame: Will be evaluated at 1 year
Bowel Diary and Bristol Stool Scale
Time frame: Will be evaluated at 1 year
Complications between the two groups
Time frame: Will be evaluated at 1 year
Duration of the Case
Time frame: Will be evaluated at 1 year
Length of hospital stay
Time frame: Will be evaluated at 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2014.
- Derived from this study: PubMed 24402594Ballard 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia C Ballard, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No bowel prep and Clear liquid diet and 2 Fleet's enemas in people with Value of the Bowel Preparation and Diet Change Versus no Intervention and Preoperative Bowel Regimen, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeon assessment of bowel preparation (time frame: Will be evaluated at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01431040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2014.