protocolSection identificationModule nctId: NCT06338332, orgStudyIdInfo id: AW23.050, W19.249, briefTitle: Obstructive Colon Cancer, a Bridge to Surgery in Right Sided Obstructive Colon Cancer, acronym: OCCBRIGHT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2028-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Amphia Hospital, class: OTHER, descriptionModule briefSummary: Rationale: Approximately 13% (range 10-28%) of all colorectal cancer patients (CRC) present with an acute obstruction. Postoperative mortality after an emergency resection is known for its high risk of morbidity and mortality. Different options can be considered in the management of obstructing right sided CRC: 1) primary resection, simultaneous treatment of obstruction and tumour resection, or 2) staged treatment of the obstruction with secondary resection of the tumour. Currently, in the Netherlands, an emergency resection has been judged to be inferior to postponing surgery. Patients who present with right sided obstructive colon cancer at one of the participating hospitals are subjected to a bridge to surgery (BTS) protocol.Objective: The primary objective of this study is to determine the feasibility of BTS protocols in right sided obstructive colon cancer and reduce mortality- and morbidity (stoma rates, major- and minor complications) rates in potentially curable patients presenting with acute obstructing colon cancer.Study design: This is a multicentre, prospective registration study Study population: All patients presenting with high clinical suspicion or histologically proven right sided colon cancer and signs of obstruction of the large bowel.Intervention: Prospective registration of the implementation of bridge to surgery protocols in patients with (acute) malignant right sided obstruction of the colon, without suspicion of perforation (tumour perforation or blow out) in order to optimize patients preoperatively. The BTS approach encompasses the utilization of either ileostomy creation, stent placement or nasogastric tube for decompression, which is subsequently followed by definitive surgical treatment at a later stage. BTS also involves pre-optimization, prior to the surgical procedure, with the following approach: optimizing the nutritional health status improving the physical health status of the patient.Main study parameters/endpoints: The primary endpoint is complication-free survival (CFS) at 90 days after hospitalization. Complication is defined here as mortality and/or development of a major complication (Clavien-Dindo classification ≥3). With a total follow up of three years. Secondary endpoints: overall mortality, morbidity (stoma rates, minor complications), in hospital stay, oncologic quality of resection and other occurring adverse events., conditionsModule conditions: Colonic Neoplasms Malignant, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Complication-free survival, secondaryOutcomes measure: Complications overall, secondaryOutcomes measure: Type of surgical intervention, secondaryOutcomes measure: Time till surgery, secondaryOutcomes measure: Resection, secondaryOutcomes measure: TNM, secondaryOutcomes measure: Hospital stay, secondaryOutcomes measure: One year stoma rate, secondaryOutcomes measure: One year survival rates, secondaryOutcomes measure: Disease free survival rates one year, secondaryOutcomes measure: Disease free survival rates three years, secondaryOutcomes measure: Three year survival rates, secondaryOutcomes measure: Tumour type (obstructing, not obstructing),, secondaryOutcomes measure: Metastasis preoperative, secondaryOutcomes measure: Pre-operative diagnostics, secondaryOutcomes measure: Type of bridge-to-surgery, secondaryOutcomes measure: Nutrition (TPN/extra nutrition), secondaryOutcomes measure: Consultation of other specialist, otherOutcomes measure: Gender, otherOutcomes measure: Age at surgery, otherOutcomes measure: ASA, otherOutcomes measure: Bodyweight, otherOutcomes measure: Height, otherOutcomes measure: Concomitant and previous therapy, otherOutcomes measure: C-reactive protein, otherOutcomes measure: Haemoglobin, otherOutcomes measure: Laboratory values, otherOutcomes measure: Leukocytes, otherOutcomes measure: Prothrombin time, otherOutcomes measure: Sodium, otherOutcomes measure: Potassium, otherOutcomes measure: Glomerular filtration rate, otherOutcomes measure: Albumin, otherOutcomes measure: Bilirubin, otherOutcomes measure: ASAT, otherOutcomes measure: ALAT, otherOutcomes measure: LDH, otherOutcomes measure: ALP, otherOutcomes measure: Gamma-GT, otherOutcomes measure: Creatinkinase, otherOutcomes measure: Phosphate, otherOutcomes measure: Lactate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amphia Hospital, status: RECRUITING, city: Breda, state: Noord-Brabant, zip: 4818CK, country: Netherlands, contacts name: Elze Lockhorst, Drs., role: CONTACT, phone: +31 613723827, email: elockhorst@amphia.nl, contacts name: Jennifer Schreinemakers, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.58656, lon: 4.77596, hasResults: False