Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-03 @ 6:45 PM
Study NCT ID:
NCT04248634
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2020-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Delayed Coloanal Anastomosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2020-01-28', 'studyFirstSubmitQcDate': '2020-01-29', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stoma rate at 90 days', 'timeFrame': '90 days', 'description': 'The rate of patients who required a stoma creation at 90 days'}, {'measure': 'Perineal complications', 'timeFrame': '90 days', 'description': 'Rates of perineal complications at 90 days after surgery'}], 'secondaryOutcomes': [{'measure': 'Clavien-Dindo complications', 'timeFrame': '90 days', 'description': 'Rate of complications according to Clavien-Dindo grading'}, {'measure': 'Functional outcomes', 'timeFrame': '12 months', 'description': 'Continence score according to the Low anterior resection syndrom score (LARS). Score from 0 to 42 (0-20 No LARS / 21-29 Minor LARS / 30-42 Major LARS). Higher score indicates worse outcome'}, {'measure': 'Quality of life assessement: EORTC QLQ30 score', 'timeFrame': '12 months', 'description': 'Quality of life using the EORTC QLQ30 score at 6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rectal neoplasmdelayed coloanal anastomosis', 'Ileostomy', 'Delayed coloanal anastomosis'], 'conditions': ['Rectal Neoplasms']}, 'descriptionModule': {'briefSummary': 'After rectal resection for cancer of the lower rectum, the restoration of continuity is done by a colo-anal anastomosis with a protective ileostomy. However, the ileostomy is very little accepted by patients. It is associated with significant morbidity and a deterioration in the quality of life.\n\nDelayed colo-anal anastomosis has been proposed as an alternative to direct colo-anal anastomosis with a protective ileostomy. The theoretical advantage of this technique is to reduce the risk of anastomotic leaks and to avoid ileostomy.\n\nIn this study, the investigators will retrospectively evaluate the short and midterm results of this technique.', 'detailedDescription': 'After rectal resection for cancer of the lower rectum, the restoration of continuity is done by a colo-anal anastomosis with a protective ileostomy. The latter reduces the risk and severity of clinical anastomotic fistulas. However, the ileostomy is very little accepted by patients. It is associated with significant morbidity reaching up to 30% of patients, a deterioration in the quality of life and the need for a second surgery to restore digestive continuity. And specifically in low-income countries, ostomy bags are expensive and are not reimbursed, and therefore constitute a heavy burden for Moroccan patients.\n\nIn order to overcome these drawbacks, delayed colo-anal anastomosis has been proposed as an alternative to direct colo-anal anastomosis with a protective ileostomy. This technique consists of externalizing the colon in the first stage by the transanal route, without creating an ileostomy, and waiting a week for the creation of the anastomosis. The theoretical advantage of this technique is to reduce the risk of anastomotic leaks and to avoid ileostomy. Several studies have shown encouraging results in the short and midterm, and it is listed among the technical options in the French recommendations for the management of rectal cancer.\n\nIn this study, the investigators will retrospectively evaluate the short and midterm results of this technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients aged above 18 years, who undergo rectal resection with the creation of delayed colo-anal anastomosis.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients\\> 18 years old.\n* Rectal resection with the creation of a delayed colo-anal anastomosis.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04248634', 'acronym': 'ACAD', 'briefTitle': 'Evaluation of Delayed Coloanal Anastomosis', 'organization': {'class': 'OTHER_GOV', 'fullName': "Institut National d'Oncologie, Morocco"}, 'officialTitle': 'Short and Midterm Results of Delayed Colo-anal Anastomosis After Rectal Resection', 'orgStudyIdInfo': {'id': 'SCOD 1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Delayed colo-anal anastomosis', 'type': 'PROCEDURE', 'description': 'Colo-anal anastomosis performed in two surgical steps:\n\n\\- Step one: the colon is exteriorized transanally and 5 cm of the colon is left outside without anastomosis creation.\n\nStep two: after 7 days, the excess colon is resected and the colo-anal anastomosis is created.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10100', 'city': 'Rabat', 'country': 'Morocco', 'facility': "Institut National d'Oncologie", 'geoPoint': {'lat': 34.01325, 'lon': -6.83255}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Under reasonable request, we would share individual patient dara'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut National d'Oncologie, Morocco", 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of surgery', 'investigatorFullName': 'Anass Majbar', 'investigatorAffiliation': "Institut National d'Oncologie, Morocco"}}}}