Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:47 PM
Study NCT ID:
NCT02777034
Status:
UNKNOWN
Last Update Posted:
2016-05-19
First Post:
2016-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopy Combined With Enhanced Recovery Pathway
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080482', 'term': 'Enhanced Recovery After Surgery'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-18', 'studyFirstSubmitDate': '2016-05-13', 'studyFirstSubmitQcDate': '2016-05-18', 'lastUpdatePostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '0-10 days'}, {'measure': 'Postoperative hospitalization cost', 'timeFrame': '0-10 days'}, {'measure': 'Hospital readmission rates', 'timeFrame': '0-30 days after discharge'}], 'primaryOutcomes': [{'measure': 'The time of Flatus and Defecation', 'timeFrame': '0-10 days'}], 'secondaryOutcomes': [{'measure': 'The time of liquid diet and semiliquid diet', 'timeFrame': '0-10 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Laparoscopy', 'Enhanced Recovery', 'Fast-track'], 'conditions': ["Crohn's Disease"]}, 'referencesModule': {'references': [{'pmid': '22948838', 'type': 'RESULT', 'citation': "Spinelli A, Bazzi P, Sacchi M, Danese S, Fiorino G, Malesci A, Gentilini L, Poggioli G, Montorsi M. Short-term outcomes of laparoscopy combined with enhanced recovery pathway after ileocecal resection for Crohn's disease: a case-matched analysis. J Gastrointest Surg. 2013 Jan;17(1):126-32; discussion p.132. doi: 10.1007/s11605-012-2012-5. Epub 2012 Sep 5."}, {'pmid': '15932565', 'type': 'RESULT', 'citation': "Andersen J, Kehlet H. Fast track open ileo-colic resections for Crohn's disease. Colorectal Dis. 2005 Jul;7(4):394-7. doi: 10.1111/j.1463-1318.2005.00788.x."}, {'pmid': '22241289', 'type': 'RESULT', 'citation': 'Veenhof AA, Vlug MS, van der Pas MH, Sietses C, van der Peet DL, de Lange-de Klerk ES, Bonjer HJ, Bemelman WA, Cuesta MA. Surgical stress response and postoperative immune function after laparoscopy or open surgery with fast track or standard perioperative care: a randomized trial. Ann Surg. 2012 Feb;255(2):216-21. doi: 10.1097/SLA.0b013e31824336e2.'}, {'pmid': '30534152', 'type': 'DERIVED', 'citation': "Zhu Y, Xiang J, Liu W, Cao Q, Zhou W. Laparoscopy Combined with Enhanced Recovery Pathway in Ileocecal Resection for Crohn's Disease: A Randomized Study. Gastroenterol Res Pract. 2018 Nov 11;2018:9648674. doi: 10.1155/2018/9648674. eCollection 2018."}]}, 'descriptionModule': {'briefSummary': "Laparoscopy combined with an enhanced recovery pathway versus laparoscopy combined with a traditional recovery pathway after ileocolon resection for Crohn's Disease.", 'detailedDescription': 'Thirty patients with CD of ileocolon will be randomly assigned to two groups.One group is ERP group which include no bowel preparation nor fasting, no abdominal drains, early removal of urinary catheter, early solid dietary intake and mobilization and restrictive fluid management.In the end,we can compare the time to first flatus、time to first flatus 、postoperative length of stay postoperative hospital expense、complication grade readmission within 30 days of discharge between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18 years≤aged≤75 years) were included if they had histologically or radiographic proven CD with disease localized to the terminal ileum with or without ascending colon involvement.\n\nExclusion Criteria:\n\n* Those patients were excluded：previous bowel resection or strictureplasty, preoperative radiological evidence of large phlegmons/abscesses/enteric fistulas (assessed by magnetic resonance imaging or computed tomography), emergency surgery, and anesthesiological contraindications to laparoscopy.'}, 'identificationModule': {'nctId': 'NCT02777034', 'briefTitle': 'Laparoscopy Combined With Enhanced Recovery Pathway', 'organization': {'class': 'OTHER', 'fullName': 'Sir Run Run Shaw Hospital'}, 'officialTitle': "Short-Term Outcomes of Laparoscopy Combined With Enhanced Recovery Pathway After Ileocolon Resection for Crohn's Disease", 'orgStudyIdInfo': {'id': 'SRRSH20160427-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced Recovery', 'description': 'Preoperative protocols：Multidisciplinary patient information、no bowel preparation、no fasting（drink 10% glucose 1000 at 21：30 night before the surgery）.\n\nIntraoperative protocols：Laparoscopic standardized technique、fluid restriction (max 500 ml/h)、no abdominal drains.\n\nPostoperative protocols：no nasogastric tube、early solid dietary intake and mobilization、urinary catheter removal on postoperative day 1、restrictive fluid management（\\<2000ml/d）.', 'interventionNames': ['Other: ER']}, {'type': 'OTHER', 'label': 'Unenhanced Recovery', 'description': 'Preoperative protocols：Patient information、Mechanical bowel preparation、Fasting since midnight before operation.\n\nIntraoperative protocols：Laparoscopic standardized technique、fluid overload (over 500 ml/h) 、place abdominal drains.\n\nPostoperative protocols：no nasogastric tube、mobilization from postoperative day 1、fluids and solids intake after first passage of stool、Urinary catheter removal on postoperative day 2/3、no restrictive fluid management（\\>2000ml/d）.', 'interventionNames': ['Other: UR']}], 'interventions': [{'name': 'ER', 'type': 'OTHER', 'otherNames': ['Enhanced Recovery'], 'description': 'Preoperative protocols：Multidisciplinary patient information、no bowel preparation、no fasting（drink 10% glucose 1000 at 21：30 night before the surgery）.\n\nIntraoperative protocols：Laparoscopic standardized technique、fluid restriction (max 500 ml/h)、no abdominal drains.\n\nPostoperative protocols：no nasogastric tube、early solid dietary intake and mobilization、urinary catheter removal on postoperative day 1、restrictive fluid management（\\<2000ml/d）.', 'armGroupLabels': ['Enhanced Recovery']}, {'name': 'UR', 'type': 'OTHER', 'otherNames': ['Un-Enhanced Recovery'], 'description': 'Preoperative protocols：Patient information、Mechanical bowel preparation、Fasting since midnight before operation.\n\nIntraoperative protocols：Laparoscopic standardized technique、fluid overload (over 500 ml/h) 、place abdominal drains.\n\nPostoperative protocols：no nasogastric tube、mobilization from postoperative day 1、fluids and solids intake after first passage of stool、Urinary catheter removal on postoperative day 2/3、no restrictive fluid management（\\>2000ml/d）.', 'armGroupLabels': ['Unenhanced Recovery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianjian Xiang, doctor', 'role': 'CONTACT', 'email': 'ybxjj1990@126.com', 'phone': '008615168326849'}], 'facility': 'Sir Run Run Shaw Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Jianjian Xiang, doctor', 'role': 'CONTACT', 'email': 'nuzwlvran@163.com', 'phone': '008613588706479'}, {'name': 'Xiang', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Wei Zhou, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Sir Run Run Shaw Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Wei Zhou', 'investigatorAffiliation': 'Sir Run Run Shaw Hospital'}}}}