Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-26 @ 5:47 AM
Study NCT ID:
NCT00554892
Status:
COMPLETED
Last Update Posted:
2010-06-30
First Post:
2007-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rectal Cancer Surgery Without Mechanical Bowel Preparation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D057868', 'term': 'Anastomotic Leak'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002400', 'term': 'Cathartics'}], 'ancestors': [{'id': 'D005765', 'term': 'Gastrointestinal Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-29', 'studyFirstSubmitDate': '2007-11-06', 'studyFirstSubmitQcDate': '2007-11-06', 'lastUpdatePostDateStruct': {'date': '2010-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall morbidity including infectious and non infectious complications', 'timeFrame': 'peri operative'}], 'secondaryOutcomes': [{'measure': '- peri operative mortality - non infectious morbidity - anastomotic leakage - hospital stay - per operative evaluation of bowel preparation - clinical evaluation of bowel preparation', 'timeFrame': '30 days, 6 months'}, {'measure': 'Evaluate the postoperative complications classified according to the DINDO classification.', 'timeFrame': 'during the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rectal cancer', 'Sphincter preservation', 'Mechanical bowel preparation', 'Post operative morbidity', 'Anastomotic leakage'], 'conditions': ['Patients With Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '21037443', 'type': 'DERIVED', 'citation': 'Bretagnol F, Panis Y, Rullier E, Rouanet P, Berdah S, Dousset B, Portier G, Benoist S, Chipponi J, Vicaut E; French Research Group of Rectal Cancer Surgery (GRECCAR). Rectal cancer surgery with or without bowel preparation: The French GRECCAR III multicenter single-blinded randomized trial. Ann Surg. 2010 Nov;252(5):863-8. doi: 10.1097/SLA.0b013e3181fd8ea9.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this controlled multicentric study is to assess rectal cancer surgery with sphincter preservation without pre operative mechanical bowel preparation', 'detailedDescription': 'Preoperative mechanical bowel preparation (MBP) (i.e. including oral laxatives, retrograde enemas and/or oral diet before surgery) is the standard practice in colorectal surgery. The importance of MBP in preventing anastomotic leakage and infectious morbidity after elective colorectal surgery has been a dogma among surgeons for many years. The main reason is the belief that postoperative complications is related to septic bowel content. However, there is a paucity of scientific evidence demonstrating the efficacy of this practice in reducing morbidity. Moreover, potential disadvantages of MBP include the requirement for a longer preoperative duration of admission before surgery, its time consuming nature, being expensive and unpleasant for the patient and expose the early population to the particular risk of fluid and electrolyte imbalance .At least eight randomized clinical trials and two meta-analyses failed to show any superiority of MBP in colorectal surgery. On the contrary, they demonstrated that preparation might lead to an increased rate of septic complications. Such initial dates lead surgeons to re-evaluate their current clinical practice in colonic surgery. But to dates, these findings cannot finally be applied to rectal surgery because of insufficient dates. To date, no study about MBP was specifically devoted to rectal surgery. Moreover, it is currently admitted that the risk of septic complications following rectal resection, as a result of the well-known risk factors, is higher than after colonic preparation. It is the reason why most of the colorectal surgeons consider that a no preparation regimen in rectal cancer surgery could represent an additive risk factor for postoperative morbidity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\> 18 years\n* patient with rectal cancer without any metastasesRectal excision with sphincter preservation with colorectal or coloanal anastomosis (with or without temporary ileostomy)\n\nExclusion Criteria:\n\n* Stage IV disease\n* Comorbidity with post operative infectious risk corticoids,immunodeficiency, Crohn's disease, ulcerative colitis ...)\n* Abdominoperineal resection\n* Emergency surgery"}, 'identificationModule': {'nctId': 'NCT00554892', 'acronym': 'PREPACOL', 'briefTitle': 'Rectal Cancer Surgery Without Mechanical Bowel Preparation', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'ClinicalTrial in Rectal Cancer Surgery Without Mechanical Bowel Preparation', 'orgStudyIdInfo': {'id': 'P060233'}, 'secondaryIdInfos': [{'id': 'AOM 06086'}, {'id': 'IDRCB 2007-A00471'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Bowel preparation', 'interventionNames': ['Procedure: bowel preparation']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'without bowel preparation', 'interventionNames': ['Procedure: no preparation bowel']}], 'interventions': [{'name': 'bowel preparation', 'type': 'PROCEDURE', 'description': 'oral laxatives, retrograde enemas', 'armGroupLabels': ['1']}, {'name': 'no preparation bowel', 'type': 'PROCEDURE', 'description': 'no preparation bowel', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '33075', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hopital Saint André', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '92100', 'city': 'Boulognes Billancourt', 'country': 'France', 'facility': 'Hopital Ambroise Paré'}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '92110', 'city': 'Clichy', 'country': 'France', 'facility': 'Hôpital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '13000', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmette', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "CRLC Val d'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHRU Trousseau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'PANIS Yves, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Cécile Jourdain', 'oldOrganization': 'Department Clinical Research of Developpement'}}}}