The Surgical Benefit and Pt.Tolerability Between Two Different Bowel Cleansing Regimens Performed Prior to Pelvic Reconstructive Surgery. Does One Bowel Cleansing Regimen Improve the Surgeons Visual Field Significantly Better Than the Other. (MBP)
| Tracking Information | |||||
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| First Received Date ICMJE | January 9, 2012 | ||||
| Last Updated Date | February 28, 2012 | ||||
| Start Date ICMJE | January 2012 | ||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To determine whether there is there an added benefit in using a MBP with regard to positioning of the large and small bowel for exposure of key anatomic structures during pelvic reconstructive surgical procedures. [ Time Frame: Surgeons will be asked to complete a questionnaire re: their impressions of the visual field on immediately Post op. ] [ Designated as safety issue: No ] The primary objective of this protocol is to determine whether there is truly an advantage for the surgeon (visually) in having patients complete a Mechanical Bowel Prep prior to surgery or if an enema completed the evening before and morning of the surgery is sufficient. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01522261 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To evaluate whether MBP (total bowel cleansing) delays the return of bowel function and/or increases the risk of perioperative leakage of stool (fecal incontinence)post operatively. [ Time Frame: We will be following the subject from the day of surgery through 2 weeks post op. ] [ Designated as safety issue: No ] | ||||
| 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 | The Surgical Benefit and Pt.Tolerability Between Two Different Bowel Cleansing Regimens Performed Prior to Pelvic Reconstructive Surgery. Does One Bowel Cleansing Regimen Improve the Surgeons Visual Field Significantly Better Than the Other. | ||||
| Official Title ICMJE | The Use of Mechanical Bowel Preparation in Pelvic Reconstructive Surgery (MBP) | ||||
| Brief Summary | Does mechanical bowel preparation (complete bowel cleansing)help the Surgeon with visualization of the operative field during laparoscopic pelvic reconstructive surgery? |
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| Detailed Description | Patients will be randomized to receive a complete MBP or not prior to their surgical procedure. All patients will use 1 fleets enema the night before surgery and one the morning of surgery to ensure that the rectum is empty of all stool. This will be done since some surgeons use a rectal probe in the rectum to help with manipulation during the procedure. Stool in the rectal vault could contaminate the surgical field and lead to an infection. Patients will be randomized at their pre-op visit and provided instructions according to the group assignment. On the day of surgery patients will be asked to complete a questionnaire in the pre-op holding area to assess their overnight symptoms including insomnia, weakness, abdominal distention, nausea, thirst and overall tolerability of the Bowel Preparation assigned. Immediately after surgery, the primary surgeon will be asked to complete a visual analog score sheet evaluating the ease of the procedure with regard to retraction of the large and small bowel to help with visualization of the sacral promontory, retraction from posterior cul-de-sac, and maintaining adequate positioning after retraction. All surgeons (attendings, fellows, and residents) will be blinded re: the patients group assignment. Each primary surgeon will be asked to assign a final grade to the procedure as easy, medium, or difficult based on overall bowel retraction. At their 2 week follow up visit patients will be asked to report return of bowel function (first bowel movement or flatus) in # of days after surgery and incidents of stool leakage post op. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) |
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| Condition ICMJE | Pelvic Organ Prolapse | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 176 | ||||
| Estimated Completion Date | January 2014 | ||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: All patients undergoing the following laparoscopic pelvic reconstructive procedures for pelvic organ prolapse:
Who understand and are willing to comply with the study requirements, including agreeing to answer the preoperative and postoperative questionnaires Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01522261 | ||||
| Other Study ID Numbers ICMJE | BUA 007-2011 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Lekha S. Hota, Boston Urogynecology Associates | ||||
| Study Sponsor ICMJE | Boston Urogynecology Associates | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Boston Urogynecology Associates | ||||
| Verification Date | February 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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