Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:59 PM
Study NCT ID:
NCT04550156
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2020-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D057868', 'term': 'Anastomotic Leak'}], 'ancestors': [{'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomised, multicenter trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2020-08-19', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comprehensive complication index', 'timeFrame': '30 days', 'description': 'The primary endpoint is the comprehensive complication index (CCI) at 30 days after the index procedure, a continuous scale to measure surgical morbidity that has been developed on the basis of the Clavien Dindo Classification for surgical complications and summarizes and weighs all postoperative complications to a scale from 0 (no complications) to 100 (death of the patient) .'}], 'secondaryOutcomes': [{'measure': 'Surgical side infections', 'timeFrame': '30 days', 'description': 'Rate of surgical side infections within 30 days'}, {'measure': 'Number of patients who died within 30 days', 'timeFrame': '30 days', 'description': 'Postoperative mortality within 30 days'}, {'measure': 'Hospital length of stay', 'timeFrame': 'immediately after discharge', 'description': 'Length of hospital stay in days'}, {'measure': 'Contribution margin', 'timeFrame': 'immediately after discharge', 'description': 'Measured as the difference between allocated costs and billed and payed income for a particular case'}, {'measure': 'Rate of anastomotic leakage', 'timeFrame': '30 days', 'description': 'Any radiologically or clinically diagnosed anastomotic leakage'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Disorders', 'Surgery--Complications', 'Colorectal Cancer', 'Anastomotic Leak', 'Complication of Surgical Procedure']}, 'referencesModule': {'references': [{'pmid': '31293019', 'type': 'BACKGROUND', 'citation': 'Bergvall M, Skullman S, Kodeda K, Larsson PA. Better survival for patients with colon cancer operated on by specialized colorectal surgeons - a nationwide population-based study in Sweden 2007-2010. Colorectal Dis. 2019 Dec;21(12):1379-1386. doi: 10.1111/codi.14760. Epub 2019 Jul 30.'}, {'pmid': '30255647', 'type': 'BACKGROUND', 'citation': '2017 European Society of Coloproctology (ESCP) collaborating group. Safety of primary anastomosis following emergency left sided colorectal resection: an international, multi-centre prospective audit. Colorectal Dis. 2018 Sep;20 Suppl 6:47-57. doi: 10.1111/codi.14373.'}, {'pmid': '30255645', 'type': 'BACKGROUND', 'citation': '2017 European Society of Coloproctology (ESCP) Collaborating Group. The 2017 European Society of Coloproctology (ESCP) international snapshot audit of left colon, sigmoid and rectal resections - Executive Summary. Colorectal Dis. 2018 Sep;20 Suppl 6:13-14. doi: 10.1111/codi.14391. No abstract available.'}, {'pmid': '28746154', 'type': 'BACKGROUND', 'citation': 'Borstlap WAA, Westerduin E, Aukema TS, Bemelman WA, Tanis PJ; Dutch Snapshot Research Group. Anastomotic Leakage and Chronic Presacral Sinus Formation After Low Anterior Resection: Results From a Large Cross-sectional Study. Ann Surg. 2017 Nov;266(5):870-877. doi: 10.1097/SLA.0000000000002429.'}, {'pmid': '25361221', 'type': 'BACKGROUND', 'citation': 'Frasson M, Flor-Lorente B, Rodriguez JL, Granero-Castro P, Hervas D, Alvarez Rico MA, Brao MJ, Sanchez Gonzalez JM, Garcia-Granero E; ANACO Study Group. Risk Factors for Anastomotic Leak After Colon Resection for Cancer: Multivariate Analysis and Nomogram From a Multicentric, Prospective, National Study With 3193 Patients. Ann Surg. 2015 Aug;262(2):321-30. doi: 10.1097/SLA.0000000000000973.'}, {'pmid': '28403477', 'type': 'BACKGROUND', 'citation': 'Amri R, Dinaux AM, Kunitake H, Bordeianou LG, Berger DL. Risk Stratification for Surgical Site Infections in Colon Cancer. JAMA Surg. 2017 Jul 1;152(7):686-690. doi: 10.1001/jamasurg.2017.0505.'}, {'pmid': '9655004', 'type': 'BACKGROUND', 'citation': 'Bisig B, Gutzwiller F, Domenighetti G. [Incidence of operations in Switzerland related to insurance status]. Swiss Surg. 1998;4(3):109-16; discussion 116-7. German.'}, {'pmid': '19144931', 'type': 'BACKGROUND', 'citation': 'Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009 Jan 29;360(5):491-9. doi: 10.1056/NEJMsa0810119. Epub 2009 Jan 14.'}, {'pmid': '24824415', 'type': 'BACKGROUND', 'citation': 'Haugen AS, Softeland E, Almeland SK, Sevdalis N, Vonen B, Eide GE, Nortvedt MW, Harthug S. Effect of the World Health Organization checklist on patient outcomes: a stepped wedge cluster randomized controlled trial. Ann Surg. 2015 May;261(5):821-8. doi: 10.1097/SLA.0000000000000716.'}, {'pmid': '25920911', 'type': 'BACKGROUND', 'citation': 'Tanner J, Padley W, Assadian O, Leaper D, Kiernan M, Edmiston C. Do surgical care bundles reduce the risk of surgical site infections in patients undergoing colorectal surgery? A systematic review and cohort meta-analysis of 8,515 patients. Surgery. 2015 Jul;158(1):66-77. doi: 10.1016/j.surg.2015.03.009. Epub 2015 Apr 25.'}, {'pmid': '28467526', 'type': 'BACKGROUND', 'citation': 'Berrios-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791. doi: 10.1001/jamasurg.2017.0904.'}, {'pmid': '31693066', 'type': 'BACKGROUND', 'citation': 'Fry DE. Review of The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Use of Bowel Preparation in Elective Colon and Rectal Surgery. JAMA Surg. 2020 Jan 1;155(1):80-81. doi: 10.1001/jamasurg.2019.4551. No abstract available.'}, {'pmid': '25703524', 'type': 'BACKGROUND', 'citation': 'McDermott FD, Heeney A, Kelly ME, Steele RJ, Carlson GL, Winter DC. Systematic review of preoperative, intraoperative and postoperative risk factors for colorectal anastomotic leaks. Br J Surg. 2015 Apr;102(5):462-79. doi: 10.1002/bjs.9697. Epub 2015 Feb 19.'}, {'pmid': '27816414', 'type': 'BACKGROUND', 'citation': 'Allegranzi B, Zayed B, Bischoff P, Kubilay NZ, de Jonge S, de Vries F, Gomes SM, Gans S, Wallert ED, Wu X, Abbas M, Boermeester MA, Dellinger EP, Egger M, Gastmeier P, Guirao X, Ren J, Pittet D, Solomkin JS; WHO Guidelines Development Group. New WHO recommendations on intraoperative and postoperative measures for surgical site infection prevention: an evidence-based global perspective. Lancet Infect Dis. 2016 Dec;16(12):e288-e303. doi: 10.1016/S1473-3099(16)30402-9. Epub 2016 Nov 2.'}, {'pmid': '31292675', 'type': 'BACKGROUND', 'citation': 'Bertschi D, Weber WP, Zeindler J, Stekhoven D, Mechera R, Salm L, Kralijevic M, Soysal SD, von Strauss M, Mujagic E, Marti WR. Antimicrobial Prophylaxis Redosing Reduces Surgical Site Infection Risk in Prolonged Duration Surgery Irrespective of Its Timing. World J Surg. 2019 Oct;43(10):2420-2425. doi: 10.1007/s00268-019-05075-y.'}, {'pmid': '30025846', 'type': 'BACKGROUND', 'citation': 'Hoang SC, Klipfel AA, Roth LA, Vrees M, Schechter S, Shah N. Colon and rectal surgery surgical site infection reduction bundle: To improve is to change. Am J Surg. 2019 Jan;217(1):40-45. doi: 10.1016/j.amjsurg.2018.07.008. Epub 2018 Jul 9.'}, {'pmid': '27098439', 'type': 'BACKGROUND', 'citation': 'Madrid E, Urrutia G, Roque i Figuls M, Pardo-Hernandez H, Campos JM, Paniagua P, Maestre L, Alonso-Coello P. Active body surface warming systems for preventing complications caused by inadvertent perioperative hypothermia in adults. Cochrane Database Syst Rev. 2016 Apr 21;4(4):CD009016. doi: 10.1002/14651858.CD009016.pub2.'}, {'pmid': '27901264', 'type': 'BACKGROUND', 'citation': 'de Vries FE, Gans SL, Solomkin JS, Allegranzi B, Egger M, Dellinger EP, Boermeester MA. Meta-analysis of lower perioperative blood glucose target levels for reduction of surgical-site infection. Br J Surg. 2017 Jan;104(2):e95-e105. doi: 10.1002/bjs.10424. Epub 2016 Nov 30.'}, {'pmid': '22071812', 'type': 'BACKGROUND', 'citation': 'Tanner J, Norrie P, Melen K. Preoperative hair removal to reduce surgical site infection. Cochrane Database Syst Rev. 2011 Nov 9;(11):CD004122. doi: 10.1002/14651858.CD004122.pub4.'}, {'pmid': '29282577', 'type': 'BACKGROUND', 'citation': 'Zhang L, Elsolh B, Patel SV. Wound protectors in reducing surgical site infections in lower gastrointestinal surgery: an updated meta-analysis. Surg Endosc. 2018 Mar;32(3):1111-1122. doi: 10.1007/s00464-017-6012-0. Epub 2017 Dec 27.'}, {'pmid': '22949137', 'type': 'BACKGROUND', 'citation': 'Junker T, Mujagic E, Hoffmann H, Rosenthal R, Misteli H, Zwahlen M, Oertli D, Tschudin-Sutter S, Widmer AF, Marti WR, Weber WP. Prevention and control of surgical site infections: review of the Basel Cohort Study. Swiss Med Wkly. 2012 Sep 4;142:w13616. doi: 10.4414/smw.2012.13616. eCollection 2012.'}, {'pmid': '22966859', 'type': 'BACKGROUND', 'citation': 'Boyce SA, Bartolo DC, Paterson HM; Edinburgh Coloproctology Unit. Subspecialist emergency management of diverticulitis is associated with reduced mortality and fewer stomas. Colorectal Dis. 2013 Apr;15(4):442-7. doi: 10.1111/codi.12022.'}, {'pmid': '23728278', 'type': 'BACKGROUND', 'citation': 'Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.'}, {'pmid': '21042553', 'type': 'BACKGROUND', 'citation': 'Rasmussen HH, Holst M, Kondrup J. Measuring nutritional risk in hospitals. Clin Epidemiol. 2010 Oct 21;2:209-16. doi: 10.2147/CLEP.S11265.'}, {'pmid': '27393156', 'type': 'BACKGROUND', 'citation': 'Hanley JA. Simple and multiple linear regression: sample size considerations. J Clin Epidemiol. 2016 Nov;79:112-119. doi: 10.1016/j.jclinepi.2016.05.014. Epub 2016 Jul 5.'}, {'pmid': '40167266', 'type': 'DERIVED', 'citation': 'Wiesler B, Gass JM, Galli R, Worni M, Nebiker C, Muller A, Pabst M, Stimpfle D, Werlen L, von Strauss Und Torney M; Clarunis EvaCol Study Group. Is There Still a Need to Discuss the Use of Antibiotic Decontamination? Results of a Prospective Cohort Study Involving 999 Left-Sided Colorectal Resections. J Am Coll Surg. 2025 Sep 1;241(3):474-483. doi: 10.1097/XCS.0000000000001396. Epub 2025 Aug 14.'}, {'pmid': '35891921', 'type': 'DERIVED', 'citation': 'Wiesler B, Gass JM, Viehl CT, Muller A, Metzger J, Hartel M, Nebiker C, Rosenberg R, Galli R, Zingg U, Ochsner A, Eisner L, Pabst M, Worni M, Henschel M, von Flue M, Zuber M, von Strauss Und Torney M. Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections (EvaCol): Study Protocol of a Multicentre, Observational Trial. Int J Surg Protoc. 2022 Jul 14;26(1):57-67. doi: 10.29337/ijsp.177. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The complication rate in colorectal surgery is high and shows a large variance depending on the patient and the treating surgeon. The primary aim of the presented study is to evaluate the introduction of a colorectal bundle to reduce the complication rate in left sided colorectal resections. The colorectal bundle is a catalog of measures consisting of several items These are for example preoperative risk stratification, antibiotic and mechanical bowel preparation and preoperative showering. The primary endpoint will be the complication rate measured as the comprehensive clinical index (CCI) within 30 days. Investigators will include patients that undergo elective or emergency left sided colorectal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged ≥ 18 years\n* Patients undergoing any left sided emergency or elective colorectal resections\n* Patients should have given or will give a general consent\n\nExclusion Criteria:\n\n* no general consent given\n* unable to provide informed general consent\n* vulnerable patients (Age \\< 18 years or patients with severe dementia)\n* the intervention is a reoperation within 30 days of primary operation\n\nExclusion criteria for an antibiotic decontamination subgroup:\n\n* known allergy to one of the applied antibiotic regimes\n* active bacterial infection requiring systemic antibiotics\n* IV or oral antibiotics in past 7 days prior to the planned decontamination\n* terminal kidney disease\n* unable to take antibiotic decontamination medication\n* pregnancy or breastfeeding\n* emergency or expedited surgery'}, 'identificationModule': {'nctId': 'NCT04550156', 'briefTitle': 'Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections', 'orgStudyIdInfo': {'id': 'EvaCol'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'Patients are treated according to current local standards'}, {'type': 'EXPERIMENTAL', 'label': 'Colorectal Bundle Arm', 'description': 'Patients are treated according to the colorectal bundle', 'interventionNames': ['Procedure: Colorectal Bundle']}], 'interventions': [{'name': 'Colorectal Bundle', 'type': 'PROCEDURE', 'description': '1. Preoperative optimization of the nutritional status: Perform nutritional risk screening (NRS), measure albumin or prealbumin preoperatively and initiate nutritional support\n2. Preoperative showering with an antiseptic agent\n3. Administer preoperative antibiotic prophylaxis\n4. Hair removal in the operative field with clippers\n5. Peri-, intra-, and postoperative warming to maintain body temperature\n6. Peri- and intraoperative glucose control\n7. Usage of a wound protection device\n8. Change of gloves and instruments after anastomosis\n9. Anastomosis only with experienced senior surgeon present in theatre for any elective and emergency procedures', 'armGroupLabels': ['Colorectal Bundle Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4410', 'city': 'Liestal', 'state': 'Basel-Landschaft', 'country': 'Switzerland', 'facility': 'Kantonsspital Baselland', 'geoPoint': {'lat': 47.48455, 'lon': 7.73446}}, {'zip': '5001', 'city': 'Aarau', 'state': 'Canton of Aargau', 'country': 'Switzerland', 'facility': 'Lantonsspital Aarau', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'Clarunis-universitäres Bauchzentrum', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '2501', 'city': 'Biel/Bienne', 'state': 'Canton of Bern', 'country': 'Switzerland', 'facility': 'Spitalzentrum Biel', 'geoPoint': {'lat': 47.13713, 'lon': 7.24608}}, {'zip': '6004', 'city': 'Lucerne', 'state': 'Canton of Lucerne', 'country': 'Switzerland', 'facility': 'Kantonsspital Luzern', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}, {'zip': '4600', 'city': 'Olten', 'state': 'Canton of Solothurn', 'country': 'Switzerland', 'facility': 'Kantonsspital Olten', 'geoPoint': {'lat': 47.34999, 'lon': 7.90329}}, {'zip': '8652', 'city': 'Schlieren', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Spital Limmattal', 'geoPoint': {'lat': 47.39668, 'lon': 8.44763}}], 'overallOfficials': [{'name': 'Marco von Strauss und Tourney, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clarunis - Universitäres Bauchzentrum Basel'}, {'name': 'Markus Zuber, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clarunis - Universitäres Bauchzentrum Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Centre Biel/Bienne', 'class': 'OTHER'}, {'name': 'Luzerner Kantonsspital', 'class': 'OTHER'}, {'name': 'Kantonsspital Aarau', 'class': 'OTHER'}, {'name': 'Kantonsspital Liestal', 'class': 'OTHER'}, {'name': 'Spital Limmattal Schlieren', 'class': 'OTHER'}, {'name': 'Kantonsspital Olten', 'class': 'OTHER'}, {'name': 'Clarunis - Universitäres Bauchzentrum Basel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}