Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2025-12-24 @ 12:24 PM
Study NCT ID:
NCT01522261
Status:
UNKNOWN
Last Update Posted:
2015-04-20
First Post:
2012-01-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 176}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-17', 'studyFirstSubmitDate': '2012-01-09', 'studyFirstSubmitQcDate': '2012-01-27', 'lastUpdatePostDateStruct': {'date': '2015-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'Surgeons will be asked to complete a questionnaire re: their impressions of the visual field on immediately Post op.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': 'We will be following the subject from the day of surgery through 2 weeks post op.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mechanical Bowel Prep'], 'conditions': ['Pelvic Organ Prolapse']}, 'referencesModule': {'references': [{'pmid': '27782976', 'type': 'DERIVED', 'citation': 'Adelowo AO, Hacker MR, Modest AM, Apostolis CA, Disciullo AJ, Hanaway KJ, Elkadry EE, Rosenblatt PL, Rogers KJ, Hota LS. The Use of Mechanical Bowel Preparation in Pelvic Reconstructive Surgery: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2017 Jan/Feb;23(1):1-7. doi: 10.1097/SPV.0000000000000346.'}]}, 'descriptionModule': {'briefSummary': 'Does mechanical bowel preparation (complete bowel cleansing)help the Surgeon with visualization of the operative field during laparoscopic pelvic reconstructive surgery?', 'detailedDescription': '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.\n\nPatients 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.\n\nImmediately 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.\n\nAt 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients undergoing the following laparoscopic pelvic reconstructive procedures for pelvic organ prolapse:\n\n* Laparoscopic sacrocervicopexy\n* Laparoscopic sacrocolpopexy\n* Laparoscopic sacrohysteropexy\n* Laparoscopic uterosacral ligament suspension\n\nWho understand and are willing to comply with the study requirements, including agreeing to answer the preoperative and postoperative questionnaires\n\nExclusion Criteria:\n\n* Previous abdominal or laparoscopic colon surgery (not including transrectal procedures)\n* History of abdominal malignancy\n* History of surgical debulking for previous malignancy\n* Non-english speaking\n* Pregnancy\n* Hx of abdomino-pelvic radiation\n* Contraindications to Sodium Phosphate\n* Contraindications to laparoscopic surgery'}, 'identificationModule': {'nctId': 'NCT01522261', 'acronym': 'MBP', 'briefTitle': '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.', 'organization': {'class': 'OTHER', 'fullName': 'Boston Urogynecology Associates'}, 'officialTitle': 'The Use of Mechanical Bowel Preparation in Pelvic Reconstructive Surgery (MBP)', 'orgStudyIdInfo': {'id': 'BUA 007-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mechanical Bowel Prep', 'description': 'Patients randomized to complete a Mechanical Bowel Prep. (complete bowel cleansing) and fleet enemas prior to surgery.', 'interventionNames': ['Other: Mechanical Bowel Prep']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No Mechanical Bowel Prep.', 'description': 'Patients randomized to complete two fleets enemas only prior to surgery.', 'interventionNames': ['Other: No Mechanical Bowel Prep']}], 'interventions': [{'name': 'Mechanical Bowel Prep', 'type': 'OTHER', 'description': 'Patients randomized to MBP will complete procedure per standard instructions.', 'armGroupLabels': ['Mechanical Bowel Prep']}, {'name': 'No Mechanical Bowel Prep', 'type': 'OTHER', 'description': 'Patient randomized to fleets enemas only prior to surgery', 'armGroupLabels': ['No Mechanical Bowel Prep.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02138', 'city': 'Cambridge', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kathleen J Rogers', 'role': 'CONTACT', 'email': 'krogers2@mah.harvard.edu', 'phone': '617-354-5452'}, {'name': 'Lekha Hota, M.D.', 'role': 'CONTACT', 'email': 'lhota@mah.harvard.edu', 'phone': '617-354-5452'}, {'name': 'Lekha Hota, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Boston Urogynecology Associates', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'overallOfficials': [{'name': 'Lekha Hota, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Urogynecology Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Urogynecology Associates', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lekha S. Hota', 'investigatorAffiliation': 'Boston Urogynecology Associates'}}}}