Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT04400669
Status:
UNKNOWN
Last Update Posted:
2021-02-12
First Post:
2020-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Mechanical Bowel Preparation Prior to Gynaecological Laparoscopic Surgeries on the Surgical Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057240', 'term': 'Patient Preference'}], 'ancestors': [{'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Surgeons and the assessor will be blind. The nurse working in the gynecology setting perform the intervention to the previously randomized patients. Patient will be told for not to reveal the intervention that she undergoes.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-11', 'studyFirstSubmitDate': '2020-05-19', 'studyFirstSubmitQcDate': '2020-05-19', 'lastUpdatePostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The surgical visibility of abdomen', 'timeFrame': 'After the introduce of first left lateral port', 'description': 'A scale title as "Objective Visual Indexing (OVI)" will be used for assessing the visibility of the Douglas pouch and adnexa. The assessment of the visibility of Douglas pouch and adnexa will be performed under standard pneumoperitoneum pressure (12mmHg) and Trendelenburg inclincation angle (30). After the first Inspection, scale of VI scoring will be calculated by adding up the points obtained from optical inspection. Higher scores mean better visuality of the surgical field.'}, {'measure': 'The lowest pneumoperitoneum pressure (PP) at standard Trendelenburg inclination angle (TIA).', 'timeFrame': 'In the initial phase of the surgery', 'description': 'The PP will be increased to 15 mmHg while keeping the TIA same, at 30o. The surgeon will displace the bowel beginning from the cecum followed by the last ileal loop above the sacral promontory. Once the bowel was displaced out of the pelvis, the PP will be stepwise decreased by 1 mmHg during 1 min intervals to the lowest pressure where the bowel is to descend towards the pelvis over the pelvic brim and/or where the surgical workspace is not adequate to proceed safely with the planned operation. This value will be recorded as the lowest PP adequate to proceed safely with the planned surgery at standard TIA (30 degree).'}, {'measure': 'The lowest Trendelenburg inclination angle (TIA) at standard pneumoperitoneum pressure (PP) adequate to proceed with the planned operation.', 'timeFrame': 'In the initial phase of the surgery', 'description': 'The PP obtained in outcome 2 will be readjusted to the standard 12 mmHg keeping the TIA same, at 300. Then, the surgeon will replace the bowel beginning from the cecum followed by the last ileal loop above the sacral promontory. Once the bowel is displaced out of the pelvis, the TIA will be gradually decreased by 1o with 15 seconds intervals to the degree where the bowel is to descend towards the pelvis over the pelvic brim. This value will be recorded as the lowest TIA adequate to proceed safely with the planned surgery at standard PP (12 mmHg).'}], 'secondaryOutcomes': [{'measure': 'Preoperative patient symptomatology', 'timeFrame': 'Right before the surgery', 'description': 'Patients will be interviewed in the preoperative holding area or in the patient\'s room about the acceptability of the intervention (MBP / diet) and adverse pre-operative events, including: nausea, insomnia, headache, thirst, weakness, tiredness, discomfort, abdominal cramps, sleep disturbances. These symptoms will be scored with using a 10-cm "Visual Analog Score" (VAS). Higher scores mean worse outcome.'}, {'measure': 'Postoperative pain', 'timeFrame': 'at 24th hours', 'description': 'The intensity of the postoperative pain was measured by an independent investigator at 24th hours with a 10-cm Visual Analog Score (VAS). Higher scores mean worse outcome.'}, {'measure': 'Complications', 'timeFrame': 'At 1st week and 6th week postoperatively or whenever it occurred.', 'description': 'Intraoperative complications, at 1st week and 6th week postoperatively, between the groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mechanical bowel preparation', 'gynecological surgery', 'Minimally invasive gynecological procedures', 'Enema', 'Trendelenburg angle', 'Pneumoperitoneum pressure'], 'conditions': ['Patient Preference', 'Patient Safety']}, 'referencesModule': {'references': [{'pmid': '28650683', 'type': 'RESULT', 'citation': 'Bakay K, Aytekin F. Mechanical bowel preparation for laparoscopic hysterectomy, is it really necessary? J Obstet Gynaecol. 2017 Nov;37(8):1032-1035. doi: 10.1080/01443615.2017.1318268. Epub 2017 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'This RCT aims to investigate the real surgical effects of MBP prior to the gynecological laparoscopic surgeries. Those effects include lowest pneumoperitoneum pressure, lowest Trendelenburg inclination angle, the ease of the surgical view and the preferences of the patients with objective measures.', 'detailedDescription': 'Mechanical bowel preparation (MBP) has been routinely used prior to minimally invasive gynaecologic procedures (MIGP) hypothetically to improve intraoperative bowel handling and visualization of the surgical field, and also to reduce faecal contamination in the setting of bowel injury and/or resection.\n\nThe studies investigating the effect of MBP on MIGP are limited and most of existing data are extrapolated from the reports of colorectal and urological surgery studies.\n\nBesides, evaluation of the surgical workspace visualization and intraoperative bowel handling are far from being objective since they were mostly measured by a 4/5/10-point Likert scales or rated verbally on scales of excellent to poor by the operating surgeons.\n\nIn contrary, it is planned to use objective visualize index, and objective surgical conditions to measure whether MBP has any effect or not.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years and older\n* Able to provide informed consent\n* Undergo laparoscopic gynecological surgery for a benign condition\n\nExclusion Criteria:\n\n* History of previous abdominal surgery\n* Clinically significant present or past systemic diseases\n* Inability to perform mechanical bowel preparation\n* Suspicion of malignancy\n* Association with non-gynaecological surgical pathologies\n* Severe endometriosis (stage ≥ III according to the classification of the American Society for Reproductive Medicine)\n* Psychiatric disorders precluding consent'}, 'identificationModule': {'nctId': 'NCT04400669', 'briefTitle': 'The Effect of Mechanical Bowel Preparation Prior to Gynaecological Laparoscopic Surgeries on the Surgical Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital'}, 'officialTitle': 'The Effect of Mechanical Bowel Preparation Prior to Gynaecological Laparoscopic Surgeries on the Pressure of Pneumoperitoneum and Trendelenburg Inclination Angle During the Surgery: A Novel Perspective for Patient Safety', 'orgStudyIdInfo': {'id': 'MBP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mechanical Bowel Preparation', 'description': 'Patients will have only clear liquids after a normal breakfast and lunch on the day before surgery and subsequently fasten for 7-9 hours prior to surgery. Patients will ingest first dose of 45 ml oral sodium phosphate (NaP) enema (BT ORAL SOLUSYON 45 ML®, Yenisehir Lab. Tic. San. Ltd. Sti, Turkey) at 4 p.m. and a second dose at 8 p.m. in the evening before the scheduled surgery.', 'interventionNames': ['Other: Mechanical Bowel Preparation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low fibre diet', 'description': 'Patients will be given detailed instructions about the pre-operative diet (total daily Fibre intake inferior to 10 g) to be used for 3 days prior to surgery.', 'interventionNames': ['Dietary Supplement: Low fibre diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MBP plus low fibre diet', 'description': 'This group will receive both mechanical bowel preparation and 3-days low fibre diet.', 'interventionNames': ['Other: MBP plus low-fibre diet']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control subjects will receive no instructions about the pre-operative diet (free diet).'}], 'interventions': [{'name': 'Mechanical Bowel Preparation', 'type': 'OTHER', 'description': 'oral sodium phosphate (NaP) enema', 'armGroupLabels': ['Mechanical Bowel Preparation']}, {'name': 'Low fibre diet', 'type': 'DIETARY_SUPPLEMENT', 'description': '3 days', 'armGroupLabels': ['Low fibre diet']}, {'name': 'MBP plus low-fibre diet', 'type': 'OTHER', 'description': '3 days low fibre diet preoperative mechanical bowel preparation', 'armGroupLabels': ['MBP plus low fibre diet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aydin', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Uzeyir Kalkan, M.D.', 'role': 'CONTACT'}, {'name': 'Uzeyir Kalkan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Egemed Hospital', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}, {'city': 'Samsun', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Kadir Bakay, Assoc.Prof.', 'role': 'CONTACT'}, {'name': 'Kadir Bakay, Assoc.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samsun Medical Faculty', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'centralContacts': [{'name': 'Uzeyir Kalkan, M.D.', 'role': 'CONTACT', 'email': 'uzekal@hotmail.com', 'phone': '+905428102539'}], 'overallOfficials': [{'name': 'Kadir Bakay, Assoc Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ondokuz Mayis Universitesi'}]}, 'ipdSharingStatementModule': {'url': 'https://drive.google.com/file/d/1E5qV7Ff_ltsXFYc0m4MgO2a4N-BmVRSQ/view?usp=sharing', 'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'After the completion of the study, for 10 years.', 'ipdSharing': 'YES', 'description': 'Raw data (for meta-analysis), statistical analyses and study protocol can be shared upon request. Processed data can be shared after completion of the study.', 'accessCriteria': 'Access will be granted right after establishing a contact.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kadir Bakay', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}