Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 1:42 AM
Study NCT ID:
NCT07339904
Status:
RECRUITING
Last Update Posted:
2026-01-14
First Post:
2025-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ProLARS Trial: Prospective Longitudinal Follow-up of Low Anterior Resection Syndrome (LARS) and COREFO Score After Rectum Surgery in Patients Undergoing Upfront Surgery or Different Neo-adjuvant Treatment Regimens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D000094123', 'term': 'Low Anterior Resection Syndrome'}], '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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Patients receive online questionnaires regarding LARS- and COREFO-scores'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-05', 'studyFirstSubmitDate': '2025-04-12', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gender', 'timeFrame': 'Baseline', 'description': 'Male, female, other'}, {'measure': 'Year of birth', 'timeFrame': 'Baseline', 'description': 'Year of birth'}, {'measure': 'Age', 'timeFrame': 'Baseline to date of surgery', 'description': 'Age at diagnosis and at surgery'}, {'measure': 'Hospital admission data', 'timeFrame': 'After rectal resection', 'description': 'Length of stay in days (date of admission for rectal resection until date of dismission)'}, {'measure': 'Medical history', 'timeFrame': 'Baseline', 'description': 'Smoking, diabetes mellitus, abdominal, cardiac, pulmonary (yes/no)'}, {'measure': 'Anthropometry', 'timeFrame': 'Baseline', 'description': 'Body mass index (kg/m²)'}, {'measure': 'Tumor location', 'timeFrame': 'After restaging prior to surgery', 'description': 'Distance in cm from recto-anal angle, based on MRI'}, {'measure': 'Presence of lateral lymph nodes', 'timeFrame': 'After restaging prior to surgery', 'description': 'Presence of lateral lymph nodes (yes/no)'}, {'measure': 'cTNM', 'timeFrame': 'After restaging prior to surgery', 'description': 'Clinical TNM classification of tumor:\n\n* T: tumor size\n* N: nodal involvement\n* M: metastasis'}, {'measure': 'Percentage of rectal circumference involved', 'timeFrame': 'After restaging prior to surgery', 'description': 'Percentage of rectal circumference involved: on imaging (CT/MRI), coloscopy or ultrasound-endoscopy'}, {'measure': 'Circumferential resection margin', 'timeFrame': 'After restaging prior to surgery', 'description': 'Circumferential resection margin (CRM; on MRI; measured from gland; in mm)'}, {'measure': 'Neoadjuvant therapy', 'timeFrame': 'From baseline to surgery', 'description': 'The eventual use of neoadjuvant therapy: radiotherapy (RT), chemotherapy (CT) (yes/no)'}, {'measure': 'Radiotherapy dose', 'timeFrame': 'From baseline to surgery', 'description': 'Radiotherapy dose (Gy)'}, {'measure': 'Chemotherapy type and frequency', 'timeFrame': 'From baseline to surgery', 'description': 'Certain type of chemotherapy, used for certain amount of cycles'}, {'measure': 'Surgical approach', 'timeFrame': 'At surgery', 'description': 'Surgical approach:\n\n* Open\n* Laparoscopy\n* Robot\n* Transanal (TaTME)'}, {'measure': 'Configuration of anastomosis', 'timeFrame': 'At surgery', 'description': 'Configuration of colorectal/coloanal anastomosis:\n\n* End-to-End\n* Side-to-End\n* End-to-Side\n* Side-to-Side'}, {'measure': 'Manual or stapled anastomosis', 'timeFrame': 'At surgery', 'description': 'Manual or stapled anastomosis'}, {'measure': 'Conversion', 'timeFrame': 'At surgery', 'description': 'Conversion during surgery:\n\n* Robot to laparoscopy (yes/no)\n* Laparoscopy to open (yes/no)'}, {'measure': 'Diverting ileostomy', 'timeFrame': 'At surgery', 'description': 'Use of a diverting ileostomy (yes/no)'}, {'measure': 'Baseline CEA', 'timeFrame': 'At baseline', 'description': 'Baseline CEA: Carcinoembryonic antigen (µg/L)'}, {'measure': 'Histology type', 'timeFrame': 'After surgery', 'description': 'Histology type of tumor (adenocarcinoma, squamous cell carcinoma, neuro-endocrine tumor etc.)'}, {'measure': 'Tumor differentiation', 'timeFrame': 'After surgery', 'description': 'Well differentiated Moderately differentiated poorly differentiated'}, {'measure': 'Tumor perforation', 'timeFrame': 'After surgery', 'description': 'Tumor perforation on histology (yes/no)'}, {'measure': 'Radical resection', 'timeFrame': 'After surgery', 'description': 'Radical resection: R0, R1, R2'}, {'measure': 'pTNM', 'timeFrame': 'After surgery', 'description': 'Pathological TNM classification of tumor\n\n* T: tumor size\n* N: nodal involvement\n* M: metastasis'}, {'measure': 'Disease free interval', 'timeFrame': 'Up to 2 years after rectal resection', 'description': 'Disease free interval: the period of time between the primary treatment of a malignancy and the first sign of tumor recurrence (in months)'}, {'measure': 'Type of complication', 'timeFrame': 'After rectal resection during admission', 'description': 'Type of complication:\n\n* Urinary tract infection\n* Pulmonary complications\n* Surgical site infection\n* Intra-abdominal collections/abscess\n* Eventration/evisceration\n* Ileus\n* Small bowel obstruction\n* Anastomotic leakage\n* Deep venous thrombosis\n* Postoperative bleeding\n* Acute renal failure\n* High output ileostomy\n* Other stoma related complications\n* Other (yes/no)'}, {'measure': 'Early complications', 'timeFrame': 'Between surgery and 30 days after surgery', 'description': 'Early complications: before 30 days after surgery'}, {'measure': 'Late complications', 'timeFrame': 'From 30 days after surgery up to 2 years after surgery', 'description': 'Late complications: more than 30 days after surgery'}, {'measure': 'Anastomotic leakage', 'timeFrame': 'Up to 3 months after surgery', 'description': 'Definition of anastomotic leakage:\n\n* Clinically manifest insufficiency of the anastomosis leading to a clinical state requiring treatment, diagnosed in accordance with surgical practice guidelines by a senior surgeon (no additional or systematic routine iconography nor colonoscopy)\n* Radiological evidence of anastomotic leakage if the patient is clinically symptomatic. Fistulas communicating with the anastomosis on CT scan are classified as AL together with presacral abscesses if extravasation of the colonic contrast is visible on radiological imaging (ref. SAFE 2019 Clinical Investigation Plan)\n\n(yes/no)'}, {'measure': 'Clavien-Dindo classification', 'timeFrame': 'After admission for rectal resection', 'description': 'Clavien-Dindo classification (grade 0, I, II, IIIa, IIIb, IVa, IVb, V):\n\nGrade I:\n\nMinor deviation from normal course; no drugs or interventions needed (only supportive care).\n\nGrade II:\n\nRequires pharmacological treatment (e.g. antibiotics, blood transfusion, TPN).\n\nGrade III:\n\nRequires surgical, endoscopic, or radiological intervention IIIa: without general anesthesia IIIb: with general anesthesia\n\nGrade IV:\n\nLife-threatening complication requiring ICU care IVa: single-organ dysfunction IVb: multi-organ dysfunction\n\nGrade V:\n\nDeath'}, {'measure': 'CCI-score', 'timeFrame': 'After admission for rectal resection', 'description': 'CCI-score: comprehensive complication index (score from 0-100 calculated with online calculator: https://www.cci-calculator.com/cci-calculator)'}], 'primaryOutcomes': [{'measure': 'The evolution of the COREFO-score (Colorectal Functional Outcome questionnaire) at 2 years after rectal surgery compared to baseline (absolute difference) will be examined', 'timeFrame': '2 years from when rectal resection or stoma reversal was performed', 'description': '27 questions on 5-point Likert scale Higher score = worse bowel function'}], 'secondaryOutcomes': [{'measure': 'Evolution of LARS-score (low anterior resection syndrome) at 2 years after rectal surgery compared to baseline (absolute difference)', 'timeFrame': '2 years from when rectal resection or stoma reversal was performed', 'description': '0-20 = no LARS 21-29 = minor LARS 30-42 = major LARS'}, {'measure': 'The evolution of the LARS-score (low anterior resection syndrome) at 2 years after rectal surgery compared to baseline (relative difference) will be examined.', 'timeFrame': '2 years from when rectal resection or stoma reversal was performed', 'description': '0-20 = no LARS 21-29 = minor LARS 30-42 = major LARS'}, {'measure': 'The evolution of the COREFO-score (Colorectal Functional Outcome questionnaire) at 2 years after rectal surgery compared to baseline (relative difference) will be examined', 'timeFrame': '2 years from when rectal resection or stoma reversal was performed', 'description': '27 questions on 5-point Likert scale Higher score = worse bowel function (min 0 - max 100)'}, {'measure': 'The evolution of the LARS-score (low anterior resection syndrome) in the absence of baseline data will be examined as well (absolute difference), comparing 2-year outcome to earliest results.', 'timeFrame': '2 years from when rectal resection or stoma reversal was performed', 'description': '0-20 no LARS 21-29 minor LARS 30-42 major LARS (min 0 - max 42)'}, {'measure': 'The evolution of the LARS-score (low anterior resection syndrome) in the absence of baseline data will be examined as well (relative difference), comparing 2-year outcome to earliest results.', 'timeFrame': '2 years from when rectal resection or stoma reversal was performed', 'description': '0-20 no LARS 21-29 minor LARS 30-42 major LARS (min 0 - max 42)'}, {'measure': 'The evolution of the COREFO-score (Colorectal Functional Outcome questionnaire) in the absence of baseline data will be examined as well (absolute difference), comparing 2-year outcome to earliest results.', 'timeFrame': '2 years from when rectal resection or stoma reversal was performed', 'description': '27 questions on 5-point Likert scale Higher score = worse bowel function (min 0 - max 100)'}, {'measure': 'The evolution of the COREFO-score (Colorectal Functional Outcome questionnaire) in the absence of baseline data will be examined as well (relative difference), comparing 2-year outcome to earliest results.', 'timeFrame': '2 years from when rectal resection or stoma reversal was performed', 'description': '27 questions on 5-point Likert scale Higher score = worse bowel function (min 0 - max 100)'}, {'measure': 'LARS-score (low anterior resection syndrome) score at diagnosis', 'timeFrame': 'At diagnosis = baseline', 'description': '0-20 no LARS 21-29 minor LARS 30-42 major LARS (min 0 - max 42) LARS = low anterior resection syndrome Using a questionnaire Unit = mean score (0-42)'}, {'measure': 'COREFO-score at diagnosis (Colorectal Functional Outcome questionnaire)', 'timeFrame': 'At diagnosis = baseline', 'description': '27 questions on 5-point Likert scale Higher score = worse bowel function (min 0 - max 100) COREFO = Colorectal Functional Outcome questionnaire Using a questionnaire Unit = mean score (0-100)'}, {'measure': 'LARS-score (low anterior resection syndrome) after neo-adjuvant therapy', 'timeFrame': 'After neo-adjuvant therapy (up to 6 months from baseline)', 'description': '0-20 no LARS 21-29 minor LARS 30-42 major LARS (min 0 - max 42) LARS = low anterior resection syndrome Using a questionnaire Unit = mean score (0-42)'}, {'measure': 'COREFO-score after neo-adjuvant therapy (Colorectal Functional Outcome questionnaire)', 'timeFrame': 'After neo-adjuvant therapy (up to 6 months from baseline)', 'description': '27 questions on 5-point Likert scale Higher score = worse bowel function (min 0 - max 100) COREFO = Colorectal Functional Outcome questionnaire Using a questionnaire Unit = mean score (0-100)'}, {'measure': 'LARS-score (low anterior resection syndrome) shortly prior to surgery when there is a delay of 4 or more weeks after finishing neoadjuvant therapy', 'timeFrame': '2 days prior to surgery', 'description': '0-20 no LARS 21-29 minor LARS 30-42 major LARS (min 0 - max 42) LARS = low anterior resection syndrome Using a questionnaire Unit = mean score (0-42)'}, {'measure': 'COREFO-score (Colorectal Functional Outcome questionnaire) shortly prior to surgery when there is a delay of 4 or more weeks after finishing neoadjuvant therapy', 'timeFrame': '2 days prior to surgery', 'description': '27 questions on 5-point Likert scale Higher score = worse bowel function (min 0 - max 100) COREFO = Colorectal Functional Outcome questionnaire Using a questionnaire Unit = mean score (0-100)'}, {'measure': 'LARS-scores (low anterior resection syndrome) postoperatively after 1 month, 3 months, 6 months, 1 year and 2 years', 'timeFrame': 'Postoperatively after 1 month, 3 months, 6 months, 1 year and 2 years', 'description': '0-20 no LARS 21-29 minor LARS 30-42 major LARS (min 0 - max 42) LARS = low anterior resection syndrome Using a questionnaire Unit = mean score (0-42)'}, {'measure': 'COREFO-scores (Colorectal Functional Outcome questionnaire) postoperatively after 1 month, 3 months, 6 months, 1 year and 2 years', 'timeFrame': 'Postoperatively after 1 month, 3 months, 6 months, 1 year and 2 years', 'description': '27 questions on 5-point Likert scale Higher score = worse bowel function (min 0 - max 100) COREFO = Colorectal Functional Outcome questionnaire Using a questionnaire Unit = mean score (0-100)'}, {'measure': 'Evolution of quality of defecation process', 'timeFrame': '2 years after rectal resection or stoma reversal', 'description': 'Visual analogue scale 0-10 0 = worst defecation ever 10 = best defecation ever'}, {'measure': 'Incapacity for work', 'timeFrame': 'At diagnose (baseline), 2 days after radiotherapy, 1 week after chemotherapy and 1 month after rectal resection', 'description': 'Time (days) between date of start work incapacity and date back to work (if not yet retired)'}, {'measure': 'Initiation of treatment for potential LARS (low anterior resection syndrome) during follow-up', 'timeFrame': 'Up to 2 years after rectal resection', 'description': 'Yes/no:\n\n* Dietary measures\n* Medication (probiotics, antidiarrheals, ...)\n* Pelvic floor physiotherapy\n* Transanal irrigation, rectal irrigation, enema\n* Neuromodulation (neurostimulator)\n* Other\n\nCalculating proportion of patients who received treatment for LARS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LARS', 'Rectal resection', 'Total mesorectal excision', 'Low anterior resection', 'Rectal carcinoma'], 'conditions': ['Rectal Adenocarcinoma', 'LARS - Low Anterior Resection Syndrome', 'Rectal Resection', 'Low Anterior Resection', 'Total Mesorectal Excision']}, 'descriptionModule': {'briefSummary': 'OBJECTIVE Low anterior resection syndrome (LARS) is a term for functional bowel complaints occurring after low anterior resection. Symptoms can range from faecal incontinence and frequent loose stools to urgency and incomplete emptying with great impact on quality of life. Little is known about the longitudinal evolution of LARS and the impact of different schedules of neoadjuvant chemoradiotherapy combined with surgery.\n\nThe investigators aim to investigate the incidence and evolution of functional bowel complaints in function of different neoadjuvant treatment regimens, type of surgery and adjuvant therapy in patients who undergo surgery for rectal cancer. The investigators focus on following objectives: evolution of LARS- and COREFO-scores per treatment regimen and their impact on work incapacity; identification of possible risk factors potentially related to functional outcome; monitoring and treatment of LARS.\n\nMETHODS This will be a multicentre prospective interventional study. The study population will consist of adult patients with rectal cancer, regardless of any neo-adjuvant therapy. Patients will be included for 5 years with a 2 year postoperative follow-up. Interim analysis will be made after 2 years of inclusion. Patients with intellectual disability or clinical colon obstruction are excluded. Automated online questionnaires including LARS and COREFO scores, incapacity for work and defecation quality will be sent at different time points (figure 1) using REDCap.\n\nRESULTS and CONCLUSIONS Longitudinal change of LARS- and COREFO-scores will be visually summarized. Patient, disease or procedure specific risk factors will be assessed as well.\n\nLARS is proven to be the principal postoperative problem after rectal surgery. If the investigators can predict the severity of LARS (minor or major LARS), this can be extremely helpful in deciding whether to perform a sphincter-sparing resection or a rectal amputation instead. Furthermore, the investigators want to offer perspective to patients who are susceptible to a disturbed postoperative bowel function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years or older.\n* Diagnosis of rectal cancer, discussed at the multidisciplinary consultation, with the intention to perform a sphincter preserving total mesorectal excision (TME) or partial mesorectal excision (PME), regardless of the need of neoadjuvant treatment.\n\nExclusion Criteria:\n\n* History of inflammatory bowel disease (Crohn's disease, ulcerative colitis) due to often persistent bowel complaints and therefore distorted baseline and follow-up data.\n* Dementia or intellectual disability.\n* Patients who are obstructive and in need a decompressive stoma or rectal stenting due to the lack of baseline data as they are often admitted to the hospital in an urgent setting"}, 'identificationModule': {'nctId': 'NCT07339904', 'acronym': 'ProLARS', 'briefTitle': 'ProLARS Trial: Prospective Longitudinal Follow-up of Low Anterior Resection Syndrome (LARS) and COREFO Score After Rectum Surgery in Patients Undergoing Upfront Surgery or Different Neo-adjuvant Treatment Regimens', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': 'ProLARS Trial: Prospective Longitudinal Follow-up of Low Anterior Resection Syndrome (LARS) and COREFO Score After Rectum Surgery in Patients Undergoing Upfront Surgery or Different Neo-adjuvant Treatment Regimens', 'orgStudyIdInfo': {'id': '6510'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Upfront surgery', 'description': 'Patients who undergo rectal resection without neo-adjuvant therapy', 'interventionNames': ['Other: Questionnaire']}, {'type': 'OTHER', 'label': 'Neo-adjuvant therapy', 'description': 'Patients who receive neo-adjuvant therapy before undergoing rectal surgery', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Online questionnaire regarding LARS- and COREFO-scores, quality of defecation process, incapacity for work and initiation of treatment for potential LARS at different moments in time', 'armGroupLabels': ['Neo-adjuvant therapy', 'Upfront surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Lieselotte Iket', 'role': 'CONTACT', 'email': 'studies.abdominaleheelkunde@uza.be', 'phone': '+32 3 821 30 00'}], 'facility': 'University Hospital Antwerp', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}], 'centralContacts': [{'name': 'Niels Komen, MD PhD', 'role': 'CONTACT', 'email': 'niels.komen@uza.be', 'phone': '+32 3 821 30 00'}, {'name': 'Juul Meurs, MD', 'role': 'CONTACT', 'email': 'juul.meurs@gmail.com', 'phone': '+32476617623'}], 'overallOfficials': [{'name': 'Niels Komen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Head of the Abdominal Surgery Department, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Niels Komen', 'investigatorAffiliation': 'University Hospital, Antwerp'}}}}