Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-30 @ 3:50 AM
Study NCT ID:
NCT01323166
Status:
COMPLETED
Last Update Posted:
2015-09-04
First Post:
2011-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life After Abdominoperineal Resection for Rectal Cancer, Comparing Two Surgical Techniques
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078542', 'term': 'Proctectomy'}], 'ancestors': [{'id': 'D000099090', 'term': 'Surgical Procedures, Colorectal'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-03', 'studyFirstSubmitDate': '2011-03-24', 'studyFirstSubmitQcDate': '2011-03-24', 'lastUpdatePostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Related Quality of life after rectal cancer surgery - possible differences due to choice of procedure', 'timeFrame': '2-7 years after operation', 'description': 'A detailed questionnaire with 250 questions, where emphasis is on physical satisfaction and emotional status as well as bowel function, sexual function and stoma function 2-7 years after rectal amputation'}], 'secondaryOutcomes': [{'measure': 'Impact of rectal cancer surgery on household finances in a long-term perspective', 'timeFrame': '2-7 years after operation', 'description': "Part of the questionnaire deals with the patients'/spouses' career and economic situation after the operation."}, {'measure': 'Impact of rectal cancer surgery and the level of intrusive thoughts', 'timeFrame': '2-7 years after operation', 'description': 'Part of the questionnaire analyses occurrence and effects of intsrusice thoughts'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rectal cancer'], 'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '25311774', 'type': 'DERIVED', 'citation': 'Angenete E, Asplund D, Andersson J, Haglind E. Self reported experience of sexual function and quality after abdominoperineal excision in a prospective cohort. Int J Surg. 2014 Nov;12(11):1221-7. doi: 10.1016/j.ijsu.2014.10.003. Epub 2014 Oct 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare self-reported health related quality of life after two different operating techniques for low rectal cancer operated by rectal amputation, using a specific and detailed questionnaire. The population has been operated over a 6 year period in one university hospital.', 'detailedDescription': 'Low rectal cancer treated by abdominoperineal resection (APR, rectal amputation)has worse prognosis than other rectal cancers, both regarding local recurrence and cancer specific survival. With a view to improve local recurrence rates a more extensive perineal operation (excision of the levator muscle) has been suggested. In our university hospital thie technique was introduced for all surgeons January 2007. A population of all patients operated from 1 January 2007 to 31 December 2009 was compared to all patients operated from 1 January 2004 to 31 December 2006 using the traditional, less extensive method, in all a six year period and 158 patients.\n\nA specific questionnaire was developed after in depth interviews, and was face-validated by patients who had undergone an APR. This questionnaire will be sent out to all patients in our population who are still alive.\n\nThe patients will be contacted first by a letter of invitation, later called by telephone to be given more information and asked for permission to send the questionnaire.\n\nThe send out of invitation letters will start March 2011.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'colorectal section of one university hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* rectal cancer operated by abdominoperineal resection 2004-2009\n\nExclusion Criteria:\n\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT01323166', 'acronym': 'APR', 'briefTitle': 'Quality of Life After Abdominoperineal Resection for Rectal Cancer, Comparing Two Surgical Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': "Retrospective Study of APR Results Regarding Patients' Self Reported Quality of Life", 'orgStudyIdInfo': {'id': 'QoL after APR at SU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Excision of the levator muscle', 'description': 'The abdominal part of the operation is performed as an TME and the perineal part of the operation is performed with the intent to get a cylindrical specimen thus removing part of or the entire levator muscle with the specimen', 'interventionNames': ['Procedure: Excision of the levator muscle']}, {'label': 'Traditional perineal operation', 'description': 'The abdominal part of the operation performed as a TME. The perineal operation performed with the intent of removing the tumour with CRM free of tumour and the levator left in place', 'interventionNames': ['Procedure: Excision of the levator muscle']}], 'interventions': [{'name': 'Excision of the levator muscle', 'type': 'PROCEDURE', 'otherNames': ['Abdomino perineal resection', 'Extra levator excision', 'Perineal excision'], 'description': 'Cylindrical perineal excision including the levator muscle', 'armGroupLabels': ['Excision of the levator muscle', 'Traditional perineal operation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE 416 85', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Dept. of Surgery, Sahlgrenska University Hospital/Ostra', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Eva Angenete, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Surgery, Sahlgernska Univesity Hospital/Ostra'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swedish Cancer Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D.', 'investigatorFullName': 'Eva Angenete', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}