Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-02-11 @ 4:58 PM
Study NCT ID:
NCT00512395
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2007-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Epidural Analgesia in Elective Laparoscopic Colorectal Resections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015360', 'term': 'Analgesia, Epidural'}], 'ancestors': [{'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2007-08-06', 'studyFirstSubmitQcDate': '2007-08-06', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-08-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain (VAS), cramps (VAS) and quantity of analgesics', 'timeFrame': '8 days'}], 'secondaryOutcomes': [{'measure': 'duration of postoperative ileus morbidity', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['laparoscopic colorectal surgery', 'epidural analgesia', 'pain score', 'postoperative ileus'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Epidural anaesthesia in open surgery is a effective method for analgesia and has a positive effect on postoperative resolution of ileus. In laparoscopic surgery, the role of epidural surgery is not established. This prospective observational trial evaluates the effect of epidural analgesia in patients undergoing elective, laparoscopic colorectal surgery.', 'detailedDescription': 'All patients with elective, laparoscopic colorectal resection between November 2004 and January 2007 were included in the trial. The decision for epidural analgesia was made by the anaesthetist and the patient. Contraindications were previous back surgery, coagulopathy, severe spondylarthrosis and refusal by the patient as contraindications.\n\nPrimary outcome was subjective feeling postoperatively, assessed with a VAS for pain and cramps and amount of analgesics used. Secondary outcomes were duration of postoperative bowel dismotility (first flatus, first defecation, first solid food intake) and general and specific morbidity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective laparoscopic colorectal resection\n\nExclusion Criteria:\n\n* emergency surgery\n* preoperatively planned stoma formation'}, 'identificationModule': {'nctId': 'NCT00512395', 'briefTitle': 'Influence of Epidural Analgesia in Elective Laparoscopic Colorectal Resections', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Influence of Epidural Analgesia in Elective Laparoscopic Colorectal Resections', 'orgStudyIdInfo': {'id': 'STZ 13/04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'epidural analgesia', 'interventionNames': ['Drug: epidural analgesia (Duracain/Fentanyl/Naropin)']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'traditional analgesia with opioids'}], 'interventions': [{'name': 'epidural analgesia (Duracain/Fentanyl/Naropin)', 'type': 'DRUG', 'description': 'naropin 0.3% or duracain 0.125% + Fentanyl via epidural catheter 4-12 ml/h', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Triemli Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Urs Zingg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Triemli Hospital', 'class': 'OTHER'}]}}}