Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-31 @ 7:48 AM
Study NCT ID:
NCT01609361
Status:
COMPLETED
Last Update Posted:
2016-08-19
First Post:
2012-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benefit of Rehabilitation Program in Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-18', 'studyFirstSubmitDate': '2012-04-20', 'studyFirstSubmitQcDate': '2012-05-29', 'lastUpdatePostDateStruct': {'date': '2016-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative morbidity at 30 days according to DINDO CLAVIEN classification', 'timeFrame': '30 days', 'description': 'Post operative morbidity at 30 days according to DINDO CLAVIEN classification (grade I to IV)'}], 'secondaryOutcomes': [{'measure': 'Mortality according to DINDO CLAVIEN classification', 'timeFrame': 'up to 30 days', 'description': 'Mortality according to DINDO CLAVIEN classification (grade V)'}, {'measure': 'Hospital stay and readmissions', 'timeFrame': 'up to first month', 'description': 'Initial hospital stay and possible unscheduled readmissions'}, {'measure': 'Intravenous perfusion stay', 'timeFrame': 'participants will be followed until the end of hospitalization an expected average of 2 weeks'}, {'measure': 'Global (SF36) quality of life', 'timeFrame': 'Preoperative and at 1, 3, 6 months', 'description': 'Global (SF36) and specific (GIQLI) quality of life Preoperative and at 1, 3, 6 months'}, {'measure': 'Specific (GIQLI) quality of life', 'timeFrame': 'Preoperative and at 1, 3, 6 months', 'description': 'Global (SF36) and specific (GIQLI) quality of life Preoperative and at 1, 3, 6 months'}, {'measure': 'Duration of laxation (gas and stool)', 'timeFrame': 'up to hospital discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rehabilitation program', 'Fast track surgery', 'Laparoscopic colorectal resection', 'Colorectal cancer', 'Morbidity'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Rehabilitation program improves operative results following conventional open colorectal surgery. Very few data are available on such program in laparoscopic colorectal surgery.', 'detailedDescription': 'The aim is to assess rehabilitation program in laparoscopic colorectal surgery in terms of 30 days peri operative complications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18 years old\n* Colorectal cancer\n* Inform and consent form signed\n* Patient has valid health insurance/coverage\n* Functional capacity ≥ 4 METs (metabolic equivalents) (up 1 floor without stopping, walking down the street 5-7km / h, major domestic activities)\n* Patients with laparoscopic resection for colorectal cancer including abdominoperineal resection\n\nInclusion Criteria (arm : Laparoscopy + Rehabilitation program):\n\n* Tobacco and alcohol weaning\n\nExclusion Criteria:\n\n* MBI \\< 18kg/m2\n* severe malnutrition\n* Metastatic colorectal cancer\n* Buzby Index \\<83\n* Combined surgery (hepatic resection or segmental resection of small intestine)\n* Urgent surgery\n* Pregnancy or maternal breastfeeding\n* Body mass index (BMI)\\> 30 kg/m2\n* Abdominoperineal resection\n* Subtotal colectomy\n* Total proctocolectomy\n* Cons to Naropin Xylocaine, droperidol, ketamine\n* Patient with a history of peptic ulcer'}, 'identificationModule': {'nctId': 'NCT01609361', 'acronym': 'REHAB', 'briefTitle': 'Benefit of Rehabilitation Program in Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Benefit of Rehabilitation Program in Colorectal Laparoscopic Surgery', 'orgStudyIdInfo': {'id': 'P111006'}, 'secondaryIdInfos': [{'id': 'IDRCB', 'type': 'OTHER', 'domain': '2011-A00803-38'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1: Standard surgery + Standard care', 'description': 'standard surgery and Standard care after surgery'}, {'type': 'OTHER', 'label': '2: Laparoscopy + Rehabilitation program', 'description': 'Laparoscopic colorectal surgery with rehabilitation program', 'interventionNames': ['Other: Rehabilitation program']}], 'interventions': [{'name': 'Rehabilitation program', 'type': 'OTHER', 'description': 'Rehabilitation program including specific anesthetic drugs, post operative fast track recovery (early diet, mobilisation, antalgics)', 'armGroupLabels': ['2: Laparoscopy + Rehabilitation program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92110', 'city': 'Clichy', 'country': 'France', 'facility': 'Service de chirurgie Colorectale / Hôpital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}