Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT04318860
Status:
COMPLETED
Last Update Posted:
2020-03-24
First Post:
2020-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pain After Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 459}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-23', 'studyFirstSubmitDate': '2020-03-17', 'studyFirstSubmitQcDate': '2020-03-23', 'lastUpdatePostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum pain on day of surgery', 'timeFrame': 'Day of surgery', 'description': 'Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)'}, {'measure': 'Maximum pain on postoperative day 1', 'timeFrame': 'Postoperative day 1', 'description': 'Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)'}, {'measure': 'Maximum pain on postoperative day 2', 'timeFrame': 'Postoperative day 2', 'description': 'Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)'}, {'measure': 'Maximum pain on postoperative day 3', 'timeFrame': 'Postoperative day 3', 'description': 'Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative pain', 'Colorectal surgery', 'Numeric rating scale', 'Minimally invasive surgery', 'Risk factors'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate pain after elective colorectal surgery and to identify risk factors for postoperative pain.\n\nPatients:All elective colorectal surgeries at the department of surgery, Umeå university Hospital, Umeå, Sweden from March 2013 to April 2017\n\nPrimary outcome:The primary outcome measurement is the numeric rating scale (NRS), graded from 0-10, on day of surgery, postoperative (POD) 1, 2, 3. The patients are questioned by nurses each morning on four postoperative days to score the maximum pain during the previous 24 hours using the NRS.', 'detailedDescription': 'This study aimed to quantify pain after elective colorectal surgery and to identify risk factors for postoperative pain.\n\nPatients: This prospective cohort study includes all consecutive patients undergoing elective colorectal surgery at Umeå University Hospital in Sweden between March 2013 and April 2017.\n\nExclusion criteria: Patients who do not score pain at any of 4 postoperative days.\n\nPrimary outcome:The primary outcome measurement is the Numeric rating scale (NRS), graded from 0-10, where 0 = no pain and 10 = the worst imaginable pain \\[18\\]. Moderate pain is defined as NRS 4-6 and severe pain as NRS 7-10. The patients are questioned by nurses each morning after day of surgery, postoperative day. 1, postoperative day 2 and postoperative day 3 to score the maximum pain during the previous 24 hours using the NRS.\n\nAll data are registered in Enhanced recovery after surgery database (EISA)\n\nClinical variables: Baseline clinical variables are assessed preoperatively. They included age, gender, body mass index (BMI), smoking, a diabetes mellitus diagnosis and American Society of Anesthesia (ASA) class. The postoperative course is registered prospectively in Enhanced recovery after surgery register (EIAS) and include preoperative oncological treatment, a histopathologically verified cancer diagnosis, the length of hospital stay and complications, including any complication, Clavien-Dindo 3b or more and anastomotic leakage within 30 days after surgery High-sensitivity C-reactive protein (CRP) is measured every postoperative morning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adults undergoing elective colorectal surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Consecutive adults undergoing elective open and minimally invasive colorectal surgery at the Department of Surgery, Umeå University Hospital, from March 2013 to April 2017\n\nExclusion Criteria: Patients not scoring pain at any of 4 postoperative days.'}, 'identificationModule': {'nctId': 'NCT04318860', 'briefTitle': 'Postoperative Pain After Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Postoperative Pain After Colorectal Surgery', 'orgStudyIdInfo': {'id': '2016/507-31'}}, 'contactsLocationsModule': {'locations': [{'zip': '901 85', 'city': 'Umeå', 'state': 'Umea', 'country': 'Sweden', 'facility': 'Dept of Surgery, Inst of Surgical and Perioperative sciences', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Karl A Franklin, prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept Surgical and periopertive sciences, Umeå university, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}