Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT03771456
Status:
UNKNOWN
Last Update Posted:
2018-12-11
First Post:
2018-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anastomotic Leakage and Enhanced Recovery Pathways After Colorectal Surgery
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1748}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-08', 'studyFirstSubmitDate': '2018-12-06', 'studyFirstSubmitQcDate': '2018-12-08', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anastomotic Leakage rate', 'timeFrame': 'up to 45 days', 'description': 'Rate of any complication related to the anastomosis after colorectal resection'}], 'secondaryOutcomes': [{'measure': 'Morbidity rate', 'timeFrame': 'up to 45 days', 'description': 'Rate of any complication after colorectal resection'}, {'measure': 'Mortality rate', 'timeFrame': 'up to 45 days', 'description': 'Rate of any death after colorectal resection'}, {'measure': 'Reoperation rate', 'timeFrame': 'up to 45 days', 'description': 'Rate of any unplanned reoperation'}, {'measure': 'Readmission rate', 'timeFrame': 'up to 45 days', 'description': 'Rate of any unplanned readmission after discharge'}, {'measure': 'Length of postoperative hospital stay', 'timeFrame': 'up to 45 days', 'description': 'number of days between primary colorectal resection and discharge'}]}, 'conditionsModule': {'conditions': ['Colorectal Neoplasms', 'Anastomotic Leak', 'Surgery--Complications']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Boushey R, Williams LJ. Management of anastomotic complications of colorectal surgery. Uptodate 2017.'}, {'pmid': '22249852', 'type': 'BACKGROUND', 'citation': 'Slieker JC, Komen N, Mannaerts GH, Karsten TM, Willemsen P, Murawska M, Jeekel J, Lange JF. Long-term and perioperative corticosteroids in anastomotic leakage: a prospective study of 259 left-sided colorectal anastomoses. Arch Surg. 2012 May;147(5):447-52. doi: 10.1001/archsurg.2011.1690.'}, {'pmid': '19228539', 'type': 'BACKGROUND', 'citation': 'Kingham TP, Pachter HL. Colonic anastomotic leak: risk factors, diagnosis, and treatment. J Am Coll Surg. 2009 Feb;208(2):269-78. doi: 10.1016/j.jamcollsurg.2008.10.015. Epub 2008 Dec 4. No abstract available.'}, {'pmid': '17245179', 'type': 'BACKGROUND', 'citation': "Hyman N, Manchester TL, Osler T, Burns B, Cataldo PA. Anastomotic leaks after intestinal anastomosis: it's later than you think. Ann Surg. 2007 Feb;245(2):254-8. doi: 10.1097/01.sla.0000225083.27182.85."}, {'pmid': '23333881', 'type': 'BACKGROUND', 'citation': 'Park JS, Choi GS, Kim SH, Kim HR, Kim NK, Lee KY, Kang SB, Kim JY, Lee KY, Kim BC, Bae BN, Son GM, Lee SI, Kang H. Multicenter analysis of risk factors for anastomotic leakage after laparoscopic rectal cancer excision: the Korean laparoscopic colorectal surgery study group. Ann Surg. 2013 Apr;257(4):665-71. doi: 10.1097/SLA.0b013e31827b8ed9.'}, {'type': 'BACKGROUND', 'citation': 'Dietz, DW, Bailey, HR. Postoperative complications. In: ASCRS Textbook of Colon and Rectal Surgery, Church, JM, Beck, DE, Wolff, BG, Fleshman, JW, Pemberton, JH, (Eds), Springer-Verlag New York, LLC, New York 2006. p.141.'}, {'pmid': '11531861', 'type': 'BACKGROUND', 'citation': 'Bruce J, Krukowski ZH, Al-Khairy G, Russell EM, Park KG. Systematic review of the definition and measurement of anastomotic leak after gastrointestinal surgery. Br J Surg. 2001 Sep;88(9):1157-68. doi: 10.1046/j.0007-1323.2001.01829.x.'}, {'pmid': '10773140', 'type': 'BACKGROUND', 'citation': 'Law WI, Chu KW, Ho JW, Chan CW. Risk factors for anastomotic leakage after low anterior resection with total mesorectal excision. Am J Surg. 2000 Feb;179(2):92-6. doi: 10.1016/s0002-9610(00)00252-x.'}, {'pmid': '16813622', 'type': 'BACKGROUND', 'citation': 'Lipska MA, Bissett IP, Parry BR, Merrie AE. Anastomotic leakage after lower gastrointestinal anastomosis: men are at a higher risk. ANZ J Surg. 2006 Jul;76(7):579-85. doi: 10.1111/j.1445-2197.2006.03780.x.'}, {'pmid': '17181849', 'type': 'BACKGROUND', 'citation': 'Platell C, Barwood N, Dorfmann G, Makin G. The incidence of anastomotic leaks in patients undergoing colorectal surgery. Colorectal Dis. 2007 Jan;9(1):71-9. doi: 10.1111/j.1463-1318.2006.01002.x.'}, {'pmid': '28097305', 'type': 'BACKGROUND', 'citation': 'Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.'}, {'pmid': '28873501', 'type': 'BACKGROUND', 'citation': 'Ljungqvist O, Thanh NX, Nelson G. ERAS-Value based surgery. J Surg Oncol. 2017 Oct;116(5):608-612. doi: 10.1002/jso.24820. Epub 2017 Sep 5.'}, {'pmid': '26928854', 'type': 'BACKGROUND', 'citation': 'Nelson G, Kiyang LN, Crumley ET, Chuck A, Nguyen T, Faris P, Wasylak T, Basualdo-Hammond C, McKay S, Ljungqvist O, Gramlich LM. Implementation of Enhanced Recovery After Surgery (ERAS) Across a Provincial Healthcare System: The ERAS Alberta Colorectal Surgery Experience. World J Surg. 2016 May;40(5):1092-103. doi: 10.1007/s00268-016-3472-7.'}, {'pmid': '24469616', 'type': 'BACKGROUND', 'citation': 'Neville A, Lee L, Antonescu I, Mayo NE, Vassiliou MC, Fried GM, Feldman LS. Systematic review of outcomes used to evaluate enhanced recovery after surgery. Br J Surg. 2014 Feb;101(3):159-70. doi: 10.1002/bjs.9324.'}, {'pmid': '25671587', 'type': 'BACKGROUND', 'citation': 'ERAS Compliance Group. The Impact of Enhanced Recovery Protocol Compliance on Elective Colorectal Cancer Resection: Results From an International Registry. Ann Surg. 2015 Jun;261(6):1153-9. doi: 10.1097/SLA.0000000000001029.'}, {'pmid': '23052794', 'type': 'BACKGROUND', 'citation': 'Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.'}, {'pmid': '15273542', 'type': 'BACKGROUND', 'citation': 'Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.'}, {'pmid': '19638912', 'type': 'BACKGROUND', 'citation': 'Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.'}, {'pmid': '19812868', 'type': 'BACKGROUND', 'citation': 'Kaiser MJ, Bauer JM, Ramsch C, Uter W, Guigoz Y, Cederholm T, Thomas DR, Anthony P, Charlton KE, Maggio M, Tsai AC, Grathwohl D, Vellas B, Sieber CC; MNA-International Group. Validation of the Mini Nutritional Assessment short-form (MNA-SF): a practical tool for identification of nutritional status. J Nutr Health Aging. 2009 Nov;13(9):782-8. doi: 10.1007/s12603-009-0214-7.'}, {'pmid': '22045723', 'type': 'BACKGROUND', 'citation': 'Skipper A, Ferguson M, Thompson K, Castellanos VH, Porcari J. Nutrition screening tools: an analysis of the evidence. JPEN J Parenter Enteral Nutr. 2012 May;36(3):292-8. doi: 10.1177/0148607111414023. Epub 2011 Nov 1.'}, {'pmid': '1334988', 'type': 'BACKGROUND', 'citation': 'Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol. 1992 Oct;13(10):606-8. No abstract available.'}, {'pmid': '39932201', 'type': 'DERIVED', 'citation': 'Catarci M, Ruffo G, Viola MG, Garulli G, Pavanello M, Scatizzi M, Bottino V, Guadagni S; Italian ColoRectal Anastomotic Leakage (iCral) study group. Enhanced Recovery Independently Lowers Failure to Rescue After Colorectal Surgery. Dis Colon Rectum. 2025 May 1;68(5):616-626. doi: 10.1097/DCR.0000000000003655. Epub 2025 Feb 11.'}]}, 'descriptionModule': {'briefSummary': 'Prospective observational multicenter study on the influence of adherence to enhanced recovery pathways on early outcomes (anastomotic leakage, morbidity, mortality, readmission, reoperation rates and length of postoperative stay) after elective colorectal surgery in Italy.', 'detailedDescription': "BACKGROUND\n\nAnastomotic leakage (AL) is a dreaded major complication after colorectal surgery. The overall incidence of anastomotic dehiscence and subsequent leaks is 2 to 7 percent when performed by experienced surgeons. The lowest leak rates are found with ileocolic anastomoses (1 to 3 percent) and the highest occur with coloanal anastomosis (10 to 20 percent). Leaks usually become apparent between five and seven days postoperatively. Almost half of all leaks occur after the patient has been discharged, and up to 12 percent occur after postoperative day (POD) 30. Late leaks often present insidiously with low-grade fever, prolonged ileus, and nonspecific symptoms attributable to other postoperative infectious complications. Small, contained leaks present later in the clinical course and may be difficult to distinguish from postoperative abscesses by radiologic imaging, making the diagnosis uncertain and underreported.\n\nThere is no uniform definition of an anastomotic dehiscence and leak. In a review of 97 studies, as an example, 56 different definitions of an anastomotic leak were used. The majority of reports define an anastomotic leak using clinical signs, radiographic findings, and intraoperative findings. The clinical signs include: Pain, Fever, Tachycardia, Peritonitis, Feculent drainage, Purulent drainage. The radiographic signs include: Fluid collections, Gas containing collections. The intraoperative findings include: Gross enteric spillage, Anastomotic disruption.\n\nRisk factors for a dehiscence and leak are classified according to the site of the anastomosis (extraperitoneal or intraperitoneal). A prospective review of 1598 patients undergoing 1639 anastomotic procedures for benign or malignant colorectal disease found a significantly increased risk of anastomotic leak with extraperitoneal compared with intraperitoneal anastomoses (6.6 versus 1.5 percent; 2.4 percent overall).\n\nMajor risk factors for an extraperitoneal AL include: The distance of the anastomosis from the anal verge (Patients with a low anterior resection and an anastomosis within 5 cm from the anal verge are the highest risk group for an anastomotic leak), Anastomotic ischemia, Male gender, Obesity.\n\nMajor risk factors for an intraperitoneal AL include: American Society of Anesthesiologists (ASA) score Grade III to V, Emergent surgery, Prolonged operative time, Hand-sewn ileocolic anastomosis.\n\nControversial, inconclusive, or pertinent negative associations between the following variables and AL have been reported: Neoadjuvant radiation therapy, Drains, Protective stoma, Hand-sewn colorectal anastomosis, Laparoscopic procedure, Mechanical bowel preparation, Nutritional status, Perioperative corticosteroids.\n\nEnhanced Recovery After Surgery (ERAS) programs for colorectal surgery have been extensively studied during the last 20 years. It is now clear that they offer a consistent reduction of overall morbidity rates, postoperative length of stay and costs, and that there is a clear dose-effect relation between adherence to at least 60-70% of the program items and these outcomes. On the other hand, little is known concerning the potential benefit of ERAS programs over AL rates or if adherence to specific items of the program may reduce AL rates.\n\nTherefore, the investigators planned this study to prospectively evaluate AL rates after colorectal resections and their interaction with known risk factors and ERAS program items.\n\nMETHODS\n\nProspective enrollment from January to December 2019 in 41 Italian surgical centers. All patients undergoing elective colorectal surgery with anastomosis will be included in a prospective database after having provided a written informed consent. A total of 1,750 patients is expected based on a mean of 43 cases/year per center.\n\nOutcome measures\n\n1. Preoperative risk factors of anastomotic leakage (age, gender, obesity, nutritional status, diabetes, cardiovascular disease, chronic liver disease, renal failure, inflammatory bowel disease, perioperative steroid therapy, ASA class I-II vs III)\n2. Operative parameters (approach, procedure, anastomotic technique, length of operation, disease stage)\n3. ERAS program items (prehabilitation, counseling, nutritional evaluation, immuno-nutrition, deep venous thrombosis prophylaxis, antibiotic prophylaxis, bowel preparation, preoperative carbohydrates load, standardized anesthesia protocol, restrictive i.v. fluid administration, control of body temperature, nausea and vomit prophylaxis, multimodal approach to opioid-sparing pain control, restrictive use of surgical drains, laparoscopic surgery, removal of nasogastric tubes before reversal of anesthesia, early removal of urinary catheter, early mobilization, early oral intake of fluids and solids, use of chewing gums and laxatives, intake of protein-rich nutritional supplements, prepare for early discharge, audit).\n\nEndpoints\n\n1. Anastomotic leakage rate\n2. Minor and major complications\n3. Length of postoperative hospital stay\n4. Readmission and reoperation rates Recorded data and follow-up Potential patient-specific and intraoperative risk factors will be recorded: gender, body mass index, nutritional status according to the Mini Nutritional Assessment short-form, surgical indication (cancer, polyps, chronic inflammatory bowel disease, diverticular disease), preoperative albuminemia, use of steroids, renal failure and dialysis, cardiovascular or respiratory disease, American Society of Anesthesia class, bowel preparation (decision made by operating surgeon), laparoscopy or laparotomy, level of anastomosis and technique (mechanical or hand-sewn, intra- or extra-corporeal), operative time, presence of drainage, and perioperative blood transfusion(s). During the postoperative period, patients will be examined by the attending surgeon daily. Fever (central temperature \\> 38 °C), pulse, abdominal signs, bowel movements, volume and aspect of drainage (if present) will be recorded daily. The attending surgeon will make any decision for complementary exams and imaging according to his own criteria. The rate of any complication will be calculated and graded including all leaks (independently of clinical significance), wound infection (according to the definitions of the Centers for Disease Control and Prevention and wound culture), pneumonia (clinical symptoms, and physical and radiological examinations), central line infection (positive blood culture), urinary tract infection (positive urine culture with bacterial count ). Patients will be followed-up in the outpatient clinic up to 6 weeks after discharge from the hospital.\n\nMain endpoint is anastomotic dehiscence (intended as any deviation from the planned postoperative course related to the anastomosis, or presence of pus or enteric contents within the drains, presence of abdominal or pelvic collection in the area of the anastomosis on postoperative CT scan, performed at the discretion of the attending surgeon, leakage of contrast through the anastomosis during enema or evident anastomotic dehiscence at reoperation for postoperative peritonitis). Thus, all detected leaks will be considered independently of clinical significance. No imaging will be performed routinely in order to search for leakage.\n\nSecondary endpoints are morbidity and mortality rates, postoperative length of stay, readmission and reoperation rates.\n\nAfter anonymization, all data of each single case will be prospectively uploaded by every local investigator on a protected web-based database. Thereafter, all data will be incorporated into a spreadsheet (MS Excel) for data analysis, checking for any discrepancy, that will be addressed and solved through strict cooperation between chief investigator, data manager and participating center.\n\nStatistical Analysis Quantitative values will be expressed as mean ± standard deviation, median and range; categorical data with percentage frequencies. Mean values of duration of stay will be compared according to the presence or absence of fistulas using Student's two-sided t test (allowing for heterogeneity of variances) or with a non-parametric Mann-Whitney test. Both univariate analysis and multivariate analysis will be performed to assess risk factors for leakage and overall complications. The odds ratio (OR) will be presented followed by its 95% confidence interval (95% CI). For all statistical tests the significant level is fixed at p \\< .05.\n\nStatistical analyses will be carried out using STATA software (Stata Corp. College Station, Texas, USA).\n\nSample size Considering that adherence to 70% of the items of an ERAS program determines a significant reduction in surgical complications after colorectal surgery, an estimation of the OR for AL and ERAS program adherence at 70% of the items is equal to 0.55 (95% c.i. 0.36-0.87); assuming a maximum error equal to 0.04, the required sample size is n=1,748 (about 874 cases per arm expected in low vs high adherence to ERAS programs)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient submitted to elective colorectal resection with anastomosis', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients submitted to laparoscopic/robotic/open/converted ileo-colo-rectal resection with anastomosis (both intra- and extra-corporeal), including planned Hartmann's reversals.\n2. American Society of Anesthesiologists' (ASA) class I, II or III\n3. Elective or delayed urgency surgery\n4. Patients' written acceptance to be included in the study.\n\nExclusion Criteria:\n\n1. American Society of Anesthesiologists' (ASA) class IV-V\n2. Patients with stoma before or at operation\n3. Simple stoma closure\n4. Transanal procedure\n5. Pregnancy\n6. Hyperthermic intraperitoneal chemotherapy for carcinomatosis."}, 'identificationModule': {'nctId': 'NCT03771456', 'acronym': 'iCral2', 'briefTitle': 'Anastomotic Leakage and Enhanced Recovery Pathways After Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale C & G Mazzoni'}, 'officialTitle': 'Anastomotic Leakage and Enhanced Recovery Pathways After Colorectal Surgery: the Italian ColoRectal Anastomotic Leakage Study Group (iCral 2)', 'orgStudyIdInfo': {'id': '2.0'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Colorectal resections', 'type': 'PROCEDURE', 'description': 'Colorectal resections'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fabriano', 'state': 'AN', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Augusto Verzelli, MD', 'role': 'CONTACT', 'email': 'augustoverzelli@libero.it'}, {'name': 'Nancy Cianforlini, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UOC Chirurgia Generale - Ospedale Profili - Fabriano (AN) - ASUR MARCHE AV2', 'geoPoint': {'lat': 43.33941, 'lon': 12.90327}}, {'city': 'Iesi', 'state': 'AN', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberto Campagnacci, MD', 'role': 'CONTACT', 'email': 'rcampagnacci@libero.it'}, {'name': 'Angela Maurizi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UOC Chirurgia Generale - Ospedale "C. Urbani" Jesi - AV2 - ASUR Marche', 'geoPoint': {'lat': 43.52142, 'lon': 13.24368}}, {'city': 'Aosta', 'state': 'AO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Millo, MD', 'role': 'CONTACT', 'email': 'paolomillo@yahoo.com'}, {'name': 'Elisa Ponte, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UOC Chirurgia Generale e d\'Urgenza - Ospedale Regionale "U. Parini" - Aosta', 'geoPoint': {'lat': 45.73764, 'lon': 7.31722}}, {'city': 'Ascoli Piceno', 'state': 'AP', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gianluca Guercioni, MD', 'role': 'CONTACT', 'email': 'gianmed@libero.it'}, {'name': 'Paolo Ciano, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UOC Chirurgia Generale - Ascoli Piceno - AV5 - ASUR Marche', 'geoPoint': {'lat': 42.85351, 'lon': 13.57395}}, {'city': 'San Benedetto del Tronto', 'state': 'AP', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Walter Siquini, MD', 'role': 'CONTACT', 'email': 'walter.siquini@sanita.marche.it'}, {'name': 'Francesco Luparini, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UOC Chirurgia Generale - San Benedetto del Tronto (AP) - AV5 - ASUR Marche', 'geoPoint': {'lat': 42.9568, 'lon': 13.87676}}, {'city': 'L’Aquila', 'state': 'AQ', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano Guadagni, MD', 'role': 'CONTACT', 'email': 'stefano.guadagni@univaq.it'}, {'name': 'Marco Clementi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "UOC Chirurgia Generale Universitaria - Ospedale San Salvatore - L'Aquila", 'geoPoint': {'lat': 42.35055, 'lon': 13.39954}}, {'city': 'Avellino', 'state': 'AV', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Crafa, MD', 'role': 'CONTACT', 'email': 'crafa@tiscali.it'}, {'name': 'Adele Noviello, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UOC Chirurgia Oncologica - AORN San Giuseppe Moscati - Avellino', 'geoPoint': {'lat': 40.91494, 'lon': 14.79103}}, {'city': 'Brescia', 'state': 'BS', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gian Luca Baiocchi, MD', 'role': 'CONTACT', 'email': 'gianluca.baiocchi@unibs.it'}, {'name': 'Sarah Molfino, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Clinica Chirurgica, Università di Brescia - UOC Chirurgia Generale 3, ASST Spedali Civili di Brescia - Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Montichiari', 'state': 'BS', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nereo Vettoretto, MD', 'role': 'CONTACT', 'email': 'nereovet@gmail.com'}, {'name': 'Emanuele Botteri, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UOC Chirurgia Generale - Ospedale Montichiari (BS) - ASST Spedali Civili di Brescia', 'geoPoint': {'lat': 45.41317, 'lon': 10.39799}}, {'zip': '12100', 'city': 'Cuneo', 'state': 'CN', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'FELICE BORGHI', 'role': 'CONTACT', 'email': 'borghi.f@ospedale.cuneo.it'}, {'name': "DESIREE' CIANFLOCCA, MD", 'role': 'SUB_INVESTIGATOR'}], 'facility': 'S.C. Chirurgia Generale e Oncologica - Azienda Ospedaliera S. Croce e Carle - Cuneo, Italia', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'city': 'Ferrara', 'state': 'FE', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gabriele Anania, MD', 'role': 'CONTACT', 'email': 'g.anania@unife.it'}, {'name': 'Serena Rubino, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UOC Chirurgia Generale 1 - Chirurgia laparoscopica - Università di Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '71013', 'city': 'San Giovanni Rotondo', 'state': 'FG', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Matteo Scaramuzzi, MD', 'role': 'CONTACT', 'email': 'm.scaramuzzi@operapadrepio.it'}, {'name': 'Matteo Tardio, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UOC di Chirurgia Addominale IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo - Foggia', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'city': 'Florence', 'state': 'FI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marco Scatizzi, MD', 'role': 'CONTACT', 'email': 'marcoscatizzi60@gmail.com'}, {'name': 'Alessandro Falsetto, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lorenzo Pandolfini, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UOC Chirurgia Generale - Ospedale S. 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