Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-25 @ 5:23 PM
Study NCT ID:
NCT04757103
Status:
COMPLETED
Last Update Posted:
2021-11-15
First Post:
2021-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Approach for Retrorectal Tumors Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-12', 'studyFirstSubmitDate': '2021-02-10', 'studyFirstSubmitQcDate': '2021-02-15', 'lastUpdatePostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative morbidity rate', 'timeFrame': '90 days', 'description': 'Postoperative morbidity according to Clavien Dindo'}], 'secondaryOutcomes': [{'measure': 'Mortality rate', 'timeFrame': '90 days', 'description': 'Mortality rate'}, {'measure': 'Reoperation rate', 'timeFrame': '90 days', 'description': 'Any reoperation linked to surgical resection of the retrorectal tumor'}, {'measure': 'Quality of surgical resection', 'timeFrame': '90 days', 'description': 'Evaluation of surgical margins according to pathological examination'}, {'measure': 'Conversion to open approach', 'timeFrame': '90 days', 'description': 'Conversion to laparotomy in case of mini-invasive approach'}, {'measure': 'Rate of functional outcomes', 'timeFrame': '90 days', 'description': 'Evaluation of fecal'}, {'measure': 'Rate of functional outcomes', 'timeFrame': '90 days', 'description': 'Evaluation urinary functions'}, {'measure': 'Functional outcomes', 'timeFrame': '90 days', 'description': 'Evaluation of sexual functions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Retrorectal tumor', 'Tail gut cyst', 'Benign tumor', 'Mini-invasive approach', 'Open approach', 'Perineal approach'], 'conditions': ['Malignant Tumor']}, 'descriptionModule': {'briefSummary': 'Aim of the study :\n\nTo evaluate postoperative outcomes of all surgical approach for retrorectal tumors.\n\nMethods :\n\nFrom 2005 to 2020, all consecutive patients who underwent surgery for a retrorectal tumor in two referral tertiary center were prospectively collected.\n\nConsidering our exlusion criterias, data from XX patients were analyzed. The cohort was separated into 2 groups according to tumor localization regarding the third sacral vertebra.\n\nShort and longterm outcomes were compared between the two groups.\n\nPrimary outcome :\n\n90 days postoperative morbidity rate', 'detailedDescription': 'Retro-rectal tumors are a group of heterogeneous and rare lesions. The actual incidence has been estimated to be approximately one case per 40,000 admissions. It is most often a benign tumor that affects young women and the origin is congenital in 60% of cases. The most common benign lesion is a tailgut cyst. Chordoma is the most common malignant lesion. They are mostly asymptomatic or pauci-symptomatic. This is why their diagnosis is regularly accidentaly after a morphological examination such as an abdominal ultrasound or a CT scan. MRI is the gold standard for determining the structure of the lesion, its origin, its topography, its extension in relation to adjacent organs, parameters that are essential to define the type of surgery and its approach.\n\nWhen a retro-rectal tumor is diagnosed, the standard treatment is surgical resection. A biopsy is not helpful if there is no suspicion of a degenerate lesion. Usually, lesions located under the third sacral vertebra (S3) are approached by dorsal transsacrococcygeal, perineal or combined approach (abdominal and perineal approach) while those located above S3 the approach is abdominal (laparotomy or laparoscopy). As these lesions are, in the majority of cases, benign, the functional impact of surgery is essential. Based on our experience in minimally invasive surgery and in particular in retro-rectal tumors, laparoscopy has become our first-line approach regardless of the location of the lesion compared to S3. Our hypothesis is that the minimally invasive approach is reliable, safe and allows satisfactory histological results to be obtained while limiting postoperative pain and functional sequelae.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting a retrorectal tumor who underwent surgical excision', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patient presenting a retrorectal tumor\n* Surgical procedure between 01/01/2005 and 31/12/2020\n\nExclusion criteria:\n\n* age \\< 18 years old\n* Patients presenting a rectal tumor\n* Patients presenting a rectal duplication'}, 'identificationModule': {'nctId': 'NCT04757103', 'acronym': 'SART cohort', 'briefTitle': 'Surgical Approach for Retrorectal Tumors Cohort', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Surgical Approach for Retro-rectal Tumors: a Retrospective Bicentric Cohort (SART Cohort)', 'orgStudyIdInfo': {'id': 'RECHMPL21_0093'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Above S3', 'description': 'Lesion located above the third sacral vertebra', 'interventionNames': ['Procedure: Resection of the retrorectal tumor']}, {'label': 'Below S3', 'description': 'Lesion located below the third sacral vertebra', 'interventionNames': ['Procedure: Resection of the retrorectal tumor']}], 'interventions': [{'name': 'Resection of the retrorectal tumor', 'type': 'PROCEDURE', 'description': 'Surgical resection of the retrorectal mass', 'armGroupLabels': ['Above S3', 'Below S3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Thomas Bardol', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université Montpellier', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}