Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-03-01 @ 10:08 AM
Study NCT ID:
NCT03920202
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2019-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long - Term Low Anterior Resection Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D000094123', 'term': 'Low Anterior Resection Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2019-02-19', 'studyFirstSubmitQcDate': '2019-04-15', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bowel function assessment using Low anterior resection syndrome questionnaire', 'timeFrame': '5 years', 'description': 'Bowel function following low anterior resection surgery for rectal cancer will be assessed using Low anterior resection syndrome score (LARS score - simple 5 question questionnaire). LARS score is a tool consisting of five items, which are as follows: incontinence due to flatus (score range from 0 to 7), incontinence due to liquid stools (score range from 0 to 3), frequency of bowel movements (score range from 0 to 5), clustering (score range from 0 to 11) and urgency (score range from 0 to 16). The severity of each item is calculated on a scale ranging from 0 to 42, with a score of 0-20 (no LARS), 21-29 (minor LARS) and 30-42 (major LARS).'}], 'secondaryOutcomes': [{'measure': 'Risk factors: age', 'timeFrame': '5 years', 'description': 'Risk factors for having worse bowel function following low anterior resection for rectal cancer - age: older patients (\\>55years) might have worse bowel function'}, {'measure': 'Risk factors: type of surgical procedure', 'timeFrame': '5 years', 'description': 'Risk factors for having worse bowel function following low anterior resection for rectal cancer - type of surgery: rectum resection with total mesorectal excision vs partial mesorectal excision will lead to worse functional outcome.'}, {'measure': 'Risk factors: preoperative chemoradiotherapy', 'timeFrame': '5 years', 'description': 'Risk factors for having worse bowel function following low anterior resection for rectal cancer - preoperative chemoradiotherapy might lead to worse functional outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rectal cancer', 'Bowel dysfunction', 'Low anterior resection syndrome', 'Low anterior resection syndrome score', 'Quality of life'], 'conditions': ['Bowel; Functional Syndrome']}, 'referencesModule': {'references': [{'pmid': '32681140', 'type': 'DERIVED', 'citation': 'Dulskas A, Kavaliauskas P, Pilipavicius L, Jodinskas M, Mikalonis M, Samalavicius NE. Long-term bowel dysfunction following low anterior resection. Sci Rep. 2020 Jul 17;10(1):11882. doi: 10.1038/s41598-020-68900-8.'}]}, 'descriptionModule': {'briefSummary': 'Data assessing the long-term bowel dysfunction following low anterior resection is still lacking. The aim of this study is to evaluate late functional results of patients who underwent rectal resection for rectal cancer. This included calculating LARS and Wexner score and identifying possible risk factors of late postoperative bowel disorders.', 'detailedDescription': 'For the last almost 30 years, the gold standard treatment for RC is low anterior resection (LAR) with total mesorectal excision (TME). Unfortunately, up to 80 % of patients undergoing LAR will suffer of bowel dysfunction including faecal urgency, frequent bowel movements, tenesmus or so called Low Anterior Resection Syndrome (LARS). Simply it has been defined as "disordered bowel function after rectal resection, leading to a detriment in quality of life". Same year LARS score was developed. This tool is easy to use and has been internationally and in Lithuania validated. Wexner score is another tool for evaluation of faecal continence.\n\nThere are only five studies investigating long-term results after rectal surgery and influence it has on patients\' daily life. In one study 47 of 51 patients experienced LARS following ultra-low anterior resection after average 6.5 years. Another study recently reported major LARS in 46% of the patients with the mean median follow-up of 14.6 years. Others showed that 47.5% of patients still experience LARS symptoms at a follow-up period of 13.7 years. Just recently published study assessed bowel function 12 years in patients undergoing rectal resection with or without preventing ileostomy. Authors found that 63 (72%) patients of 87 experienced LARS symptoms with more than a half complaining of major LARS. Moreover, just last year a study published showing that 73% of patients had LARS at first follow up 5 years after the surgery. During the second visit (another 5 years later) same numbers were seen.\n\nThe aim of this study was to evaluate late functional results of patients who underwent rectal resection for rectal cancer. This included calculating LARS and Wexner score and identifying possible risk factors of late postoperative bowel disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'From 2007 through 2012, we identified a study population of 92 patients with biopsy proven, rectal cancer without distant metastasis located up to 15 cm from anal verge and undergoing low anterior resection with partial or total mesorectal excision. Preoperative staging was performed based on a digital rectal examination, chest and abdominal computer tomography scan (CT), pelvic magnetic resonance imaging (MRI) and colonoscopy with a biopsy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed with rectal cancer without metastasis\n* signed consent form\n* more than 5 years following the surgery\n\nExclusion Criteria:\n\n* unwilling to participate\n* stage IV disease\n* change in operative plan - end colostomy formed'}, 'identificationModule': {'nctId': 'NCT03920202', 'acronym': 'LongLARS', 'briefTitle': 'Long - Term Low Anterior Resection Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos'}, 'officialTitle': 'Long - Term Bowel Dysfunction Following Low Anterior Resection', 'orgStudyIdInfo': {'id': 'LongLARS'}}, 'contactsLocationsModule': {'locations': [{'zip': '08406', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}], 'overallOfficials': [{'name': 'Narimantas Samapavicius, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Klaipėda University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only results of the study will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Audrius Dulskas', 'investigatorAffiliation': 'National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos'}}}}