Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-26 @ 1:37 AM
Study NCT ID:
NCT00747292
Status:
UNKNOWN
Last Update Posted:
2008-09-05
First Post:
2008-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peri-Operative Management of Patients Undergoing Laparoscopic Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000076385', 'term': 'Diverticular Diseases'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007268', 'term': 'Injections, Epidural'}, {'id': 'D010323', 'term': 'Passive Cutaneous Anaphylaxis'}], 'ancestors': [{'id': 'D007278', 'term': 'Injections, Spinal'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012882', 'term': 'Skin Tests'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D000937', 'term': 'Antigen-Antibody Reactions'}, {'id': 'D055633', 'term': 'Immune System Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 99}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-09-04', 'studyFirstSubmitDate': '2008-09-04', 'studyFirstSubmitQcDate': '2008-09-04', 'lastUpdatePostDateStruct': {'date': '2008-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'Once the patient is safe to go home'}], 'secondaryOutcomes': [{'measure': 'Pain, time till flatus, time till bowels open, incidence of nausea and vomiting, quality of life', 'timeFrame': 'Once secondary outcomes are successful, patient can go home'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['laparoscopic', 'colon', 'analgesia', 'fluid optimised'], 'conditions': ['Neoplasm', 'Diverticular Disease', 'Analgesia']}, 'referencesModule': {'references': [{'pmid': '14515286', 'type': 'BACKGROUND', 'citation': 'Senagore AJ, Delaney CP, Mekhail N, Dugan A, Fazio VW. Randomized clinical trial comparing epidural anaesthesia and patient-controlled analgesia after laparoscopic segmental colectomy. Br J Surg. 2003 Oct;90(10):1195-9. doi: 10.1002/bjs.4223.'}, {'pmid': '11391364', 'type': 'BACKGROUND', 'citation': 'Senagore AJ, Whalley D, Delaney CP, Mekhail N, Duepree HJ, Fazio VW. Epidural anesthesia-analgesia shortens length of stay after laparoscopic segmental colectomy for benign pathology. Surgery. 2001 Jun;129(6):672-6. doi: 10.1067/msy.2001.114648.'}, {'pmid': '17160649', 'type': 'BACKGROUND', 'citation': 'Taqi A, Hong X, Mistraletti G, Stein B, Charlebois P, Carli F. Thoracic epidural analgesia facilitates the restoration of bowel function and dietary intake in patients undergoing laparoscopic colon resection using a traditional, nonaccelerated, perioperative care program. Surg Endosc. 2007 Feb;21(2):247-52. doi: 10.1007/s00464-006-0069-5. Epub 2006 Dec 9.'}, {'pmid': '12437707', 'type': 'BACKGROUND', 'citation': 'Kong SK, Onsiong SM, Chiu WK, Li MK. Use of intrathecal morphine for postoperative pain relief after elective laparoscopic colorectal surgery. Anaesthesia. 2002 Dec;57(12):1168-73. doi: 10.1046/j.1365-2044.2002.02873.x.'}]}, 'descriptionModule': {'briefSummary': 'The aim is to ascertain which method out of epidural, spinal or patient controlled analgesia (PCA) is the most appropriate in fluid optimised patients after laparoscopic colorectal surgery in terms of pain control, length of hospital stay and time for gut recovery. The second aim is to assess the physiological changes that occur when the patient is placed in steep trendelenberg position together with the creation of the pneumoperitoneum.', 'detailedDescription': 'Patients will be randomized into one of 3 groups - A, B or C. In order to remove the major confounding factor of hypovolaemia, all patients will have an oesophageal doppler inserted in order to achieve fluid optimisation. Each group will then either have an epidural, spinal or a PCA for post operative analgesia depending on the randomisation. All patients will follow a common postoperative care pathway to standardize the other factors.\n\nPatients will be asked to report parameters including pain visual analogue score (VAS) chart three times a day. Recovery of bowel functions (passage of flatus, bowel movement, and diet intake), additional analgesia consumption, time to first ambulation, analgesia related side-effects and time to discharge will be recorded.\n\nIn addition whilst the patients fluid status is optimized during surgery with the oesophageal Doppler, the physiological changes that occur with the steep trendelenberg position and the pneumoperitoneum will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with colorectal disease that requires a bowel resection who agree to have laparoscopic surgery with placement of an oesophageal doppler and a central line and who agree to be randomised with regards to a post operative analgesic regime.\n\nExclusion Criteria:\n\n* Patients will be excluded from the post operative analgesia trial if they have abnormal clotting, skin infection over or near the back, presence of neurological disorders or anatomical abnormalities of the vertebral column, or for a reason identified by the anaesthetist.\n* Patients will also be excluded if there is a contra-indication to oesophageal doppler such as oesophageal disease, recent oesophageal or upper airway surgery, moderate to severe aortic valve disease and bleeding diathesis.'}, 'identificationModule': {'nctId': 'NCT00747292', 'briefTitle': 'Peri-Operative Management of Patients Undergoing Laparoscopic Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Minimal Access Therapy Training Unit'}, 'officialTitle': 'Randomised Controlled Trial Comparing the Effects of Epidural, Spinal and PCA in Patients Undergoing Laparoscopic Colectomy.', 'orgStudyIdInfo': {'id': '07/H1111/70'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Epidural', 'description': 'Epidural', 'interventionNames': ['Procedure: epidural']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Spinal', 'interventionNames': ['Procedure: Spinal']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Patients in this limb receive a PCA', 'interventionNames': ['Procedure: PCA']}], 'interventions': [{'name': 'epidural', 'type': 'PROCEDURE', 'description': 'Patients in this limb receive epidural analgesia', 'armGroupLabels': ['Epidural']}, {'name': 'PCA', 'type': 'PROCEDURE', 'description': 'Patients in this limb receive a PCA for their pain control', 'armGroupLabels': ['3']}, {'name': 'Spinal', 'type': 'PROCEDURE', 'description': 'Patients in limb will receive spinal analgesia', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GU2 9PS', 'city': 'Guildford', 'state': 'Surrey', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Bruce F Levy, MRCS', 'role': 'CONTACT', 'email': 'brucelevy22@hotmail.com', 'phone': '07769656842'}, {'name': 'Bruce F Levy, MRCS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MATTU', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}], 'centralContacts': [{'name': 'Bruce F Levy, MRCS', 'role': 'CONTACT', 'email': 'brucelevy22@hotmail.com', 'phone': '07769656842'}], 'overallOfficials': [{'name': 'Tim Rockall, FRCS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Minimal Access Therapy Training Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minimal Access Therapy Training Unit', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Bruce Levy', 'oldOrganization': 'MATTU'}}}}