Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-25 @ 4:23 PM
Study NCT ID:
NCT05485857
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2022-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Arrangement of Small Intestine Order on the Recovery of Bowel Function After Laparoscopic Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2022-07-24', 'studyFirstSubmitQcDate': '2022-08-01', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First flatus time after surgery', 'timeFrame': '50 hours', 'description': "The investigators will record the time from the end of the surgery to the patient's first flatus time by hours."}], 'secondaryOutcomes': [{'measure': 'Time to liquid diet', 'timeFrame': '70 hours', 'description': "The investigators will record the time from the end of the surgery to the patient's first diet time by hours."}, {'measure': 'Postoperative hospital stay', 'timeFrame': '30 days', 'description': "The investigators will record the time from the end of the surgery to the patient's decharge time by days."}, {'measure': 'Paralytic ileus time after surgery', 'timeFrame': '30 days', 'description': "The investigators will record the time after surgery if the patient's first fluid time is more than seven days after the operation."}, {'measure': 'First defecate time after surgery', 'timeFrame': '70 hours', 'description': "The investigators will record the time from the end of the surgery to the patient's first defecate time by hours."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'The method of arranging and restoring the position of the small intestine under laparoscopy is used to determine whether it can promote the recovery of intestinal function after colorectal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed colorectal cancer, patients undergoing colon cancer or radical resection of high rectal cancer；\n* Tumor Stage (TNM): I-III；\n* Age: \\>18 years old; \\<80 years old;\n* ASA: I-III;\n* Agree and sign the informed consent form.\n\nExclusion Criteria:\n\n* Stoma patients；\n* Patients with preoperative intestinal obstruction；\n* Constipation patients (More than three days before the last bowel movement)；\n* Combined other organ resection patients；\n* Stroke or spinal cord injury patients；\n* Long-term opioid use patients；\n* Patients with a history of previous abdominal surgery；\n* Patients refused entry into the trial；'}, 'identificationModule': {'nctId': 'NCT05485857', 'briefTitle': 'Influence of Arrangement of Small Intestine Order on the Recovery of Bowel Function After Laparoscopic Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Influence of Arrangement of Small Intestine Order on the Recovery of Bowel Function After Laparoscopic Colorectal Surgery.', 'orgStudyIdInfo': {'id': 'CHCS-intestine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arrangement group', 'description': 'Experimental group: After the completion of laparoscopic-assisted colorectal cancer surgery, the chief surgeon performed laparoscopic small bowel arrangement before closing the abdomen, straightening the small bowel from the colon-small bowel anastomosis or the ileocecal valve to the ligament of Trevor, and restoring the original position of the small bowel. Afterwards, close the abdomen.', 'interventionNames': ['Procedure: Arrangement of small intestine order before close the abdomen']}, {'type': 'NO_INTERVENTION', 'label': 'No arrangement group', 'description': 'No arrangement group: After completing the routine operation of laparoscopic-assisted colorectal cancer surgery, the abdomen was closed directly.'}], 'interventions': [{'name': 'Arrangement of small intestine order before close the abdomen', 'type': 'PROCEDURE', 'description': 'After the completion of laparoscopic-assisted colorectal cancer surgery, the chief surgeon performed laparoscopic small bowel arrangement before closing the abdomen, straightening the small bowel from the colon-small bowel anastomosis or the ileocecal valve to the ligament of Trevor, and restoring the original position of the small bowel. Afterward, close the abdomen.', 'armGroupLabels': ['Arrangement group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Wei Zhang', 'role': 'STUDY_CHAIR', 'affiliation': 'Changhai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of colorectal surgery', 'investigatorFullName': 'Wei Zhang', 'investigatorAffiliation': 'Changhai Hospital'}}}}