[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587766":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":29,"studyPopulation":13,"armGroups":30,"interventions":41,"overallOfficials":46,"centralContacts":50,"locations":59,"responsibleParty":131,"collaborators":133,"id":146,"slug":147,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":148,"sex":154,"minAge":155,"maxAge":13,"enrollmentInfo":156,"targetDuration":13,"studyType":159,"phases":160,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":169,"whyStopped":13,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"University of Birmingham","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":14},[9],{"measure":10,"description":11,"timeFrame":12},"Training and checklist completion","Measure simulation training and checklist completion rate for participants undergoing surgery to refine future implementation (intervention clusters only)","Within 30 days postoperatively",null,[15,19],{"measure":16,"description":17,"timeFrame":18},"Duration of time to recruit sample size per cluster","Measure duration of time to recruit 25 participants per cluster (to determine duration of potential full trial)","Within 6 months post cluster activation",{"measure":20,"description":21,"timeFrame":12},"Complication rates","Measure 30-day overall complication rates to inform overall sample size of potential full trial",{"allocation":23,"interventionModel":24,"interventionModelDescription":25,"primaryPurpose":6,"observationalModel":13,"timePerspective":13,"maskingInfo":26},"RANDOMIZED","PARALLEL","Pilot cluster randomised trial.",{"masking":27,"maskingDescription":28,"whoMasked":13},"NONE","Given this is a cluster trial, blinding of participants are not relevant as the entire cluster will be randomised to either the intervention or usual care.","Title: Reducing deaths after surgery in low- and middle-income countries: A pilot cluster randomised trial\n\nAim: This pilot randomised cluster trial aims to evaluate the feasibility of a large-scale cluster randomised trial to assess the effectiveness and implementation of a pre-operative checklist to reduce deaths after surgery. If this pilot study is successful, we aim to assess the intervention in a separate full-scale cluster randomised trial.\n\n* Objective 1: To determine feasibility and fidelity of delivering the intervention.\n* Objective 2: To determine the rate recruitment to inform how long it will take to recruit to a future cluster randomised trial.\n* Objective 3: To obtain information on postoperative outcomes to help inform the outcomes used and sample size of the future cluster randomised trial.\n\nDesign: Pilot cluster randomised trial.\n\nInclusion: Adult (\\>18 years old) non-pregnant patients undergoing emergency abdominal surgery with an incision of ≥5cm.\n\nExclusion: Patients undergoing minimally invasive surgery, or surgery for appendicitis.\n\nIntervention: SurgPASS is an intervention of a preoperative checklist for early recognition and treatment of acutely unwell surgical patients implemented through simulation training and clinical champions.\n\nComparator: Usual care as per local practice at that site.\n\nFollow-up period: 30-days from surgery.\n\nNumber of participants: 300 participants: 25 participants in each of 12 clusters (hospitals), from 6 countries.\n\nOutcomes: Since this is a pilot study, there are no pre-specified primary outcomes. However, there are four key outcomes of interest to assess ahead of the main phase randomised clinical trial.\n\n* Outcome 1: Measure simulation training and checklist completion rate for participants undergoing surgery to refine future implementation (intervention clusters only)\n* Outcome 2: Measure duration of time to recruit 25 participants per cluster (to determine duration of potential full trial)\n* Outcome 3: Measure 30-day overall complication rates to inform overall sample size of potential full trial",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"Intervention - Surgpass checklist and training champions","EXPERIMENTAL","A preoperative checklist for early recognition and treatment of acutely unwell surgical patients implemented through simulation training and clinical champions.",[36],"Other: SurgPASS - intervention",{"label":38,"type":39,"description":40,"interventionNames":13},"Comparator - usual care","NO_INTERVENTION","Usual care as per local practice at that site.",[42],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":13},"SurgPASS - intervention","SurgPASS consists of a preoperative surgical passport used for any patients requiring emergency laparotomy, a simulation training course and local clinical champions.",[32],[47],{"name":48,"affiliation":5,"role":49},"Aneel Bhangu","PRINCIPAL_INVESTIGATOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":13,"email":55},"Rachel Lillywhite","CONTACT","+44 (0)121 415 9103","r.e.lillywhite@bham.ac.uk",{"name":57,"role":53,"phone":54,"phoneExt":13,"email":58},"Divya Kapoor","d.kapoor@bham.ac.uk",[60,75,89,103,117],{"facility":61,"status":13,"city":62,"state":13,"zip":13,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"University of Abomey-Calavi, Abomey-Calavi","Cotonou","Benin","BJ",{"type":66,"coordinates":67},"Point",[68,69],2.41833,6.36536,{"lat":69,"lon":68},[72],{"name":73,"role":53,"phone":13,"phoneExt":13,"email":74},"Ismail Lawani","ismaillawani@gmail.com",{"facility":76,"status":13,"city":77,"state":13,"zip":13,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Tamale Teaching Hospital, Tamale","Tamale","Ghana","GH",{"type":66,"coordinates":81},[82,83],-0.8393,9.40079,{"lat":83,"lon":82},[86],{"name":87,"role":53,"phone":13,"phoneExt":13,"email":88},"Stephen Tabiri","kstephenba14@gmail.com",{"facility":90,"status":13,"city":91,"state":13,"zip":13,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Christian Medical College (CMC) & Hospital, Ludhiana, Ludhiana, 141008","Ludhiana","India","IN",{"type":66,"coordinates":95},[96,97],75.85379,30.91204,{"lat":97,"lon":96},[100],{"name":101,"role":53,"phone":13,"phoneExt":13,"email":102},"Parvez Haque","pdhaque@gmail.com",{"facility":104,"status":13,"city":105,"state":13,"zip":13,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Lagos University Teaching Hospital (Hub), Lagos","Lagos","Nigeria","NG",{"type":66,"coordinates":109},[110,111],3.39467,6.45407,{"lat":111,"lon":110},[114],{"name":115,"role":53,"phone":13,"phoneExt":13,"email":116},"Adesoji Ademuyiwa","adesojiademuyiwa@yahoo.co.uk",{"facility":118,"status":13,"city":119,"state":13,"zip":13,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"University Teaching Hospital of Kigali (Hub), Kigali","Kigali","Rwanda","RW",{"type":66,"coordinates":123},[124,125],30.05885,-1.94995,{"lat":125,"lon":124},[128],{"name":129,"role":53,"phone":13,"phoneExt":13,"email":130},"Faustin Ntirenganya","fostino21@yahoo.fr",{"type":132,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[134,136,139,141,144],{"name":135,"class":6},"Lagos State University",{"name":137,"class":138},"Christian Medical College and Hospital, Ludhiana","UNKNOWN",{"name":140,"class":138},"University Teaching Hospital of Kigali",{"name":142,"class":143},"Ministry of Health, Ghana","OTHER_GOV",{"name":145,"class":6},"Université d'Abomey-Calavi","100587766","reducing-deaths-after-surgery-in-low--and-middle-income-countries-a-pilot-cluster-randomised-trial-100587766",false,"NCT06932653","Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial","SurgPASS: Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial","SurgPASS","Inclusion criteria:\n\n* Patients undergoing emergency major abdominal surgery (i.e., midline or non-midline) with an incision greater than or equal to 5cm\n* Patient must not be pregnant\n* Adults only (greater than or equal to 18 years old)\n\nExclusion criteria:\n\n* Minimally invasive surgery\n* Surgery for appendicitis","ALL","18 Years",{"count":157,"type":158},300,"ESTIMATED","INTERVENTIONAL",[161],"NA","SurgPASS is a pilot randomised cluster trial utilising a pre-operative checklist with the aim of reducing deaths after surgery. If SurgPASS is successful, the intervention will be implemented in a separate full-scale cluster randomised trial.",[164],"Post-operative Complications",[166,167,168],"pilot","cluster","surgical safety","NOT_YET_RECRUITING","2025-04-10",{"date":172,"type":173},"2025-04-17","ACTUAL",{"date":175,"type":158},"2025-06-01",{"date":177,"type":158},"2026-01-31",{"name":5,"class":6},5]