Nctid:
NCT06611462
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000006547", "term"=>"Hernia"}, {"id"=>"D000011183", "term"=>"Postoperative Complications"}, {"id"=>"D000006555", "term"=>"Hernia, Ventral"}], "ancestors"=>[{"id"=>"D000020763", "term"=>"Pathological Conditions, Anatomical"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000046449", "term"=>"Hernia, Abdominal"}], "browseLeaves"=>[{"id"=>"M3774", "name"=>"Alcohol Drinking", "relevance"=>"LOW"}, {"id"=>"M12701", "name"=>"Obesity", "relevance"=>"LOW"}, {"id"=>"M25306", "name"=>"Malnutrition", "relevance"=>"LOW"}, {"id"=>"M14065", "name"=>"Postoperative Complications", "asFound"=>"Postoperative Complications", "relevance"=>"HIGH"}, {"id"=>"M9625", "name"=>"Hernia", "asFound"=>"Hernia", "relevance"=>"HIGH"}, {"id"=>"M9633", "name"=>"Hernia, Ventral", "asFound"=>"Ventral Hernia", "relevance"=>"HIGH"}, {"id"=>"M22519", "name"=>"Pathological Conditions, Anatomical", "relevance"=>"LOW"}, {"id"=>"M25675", "name"=>"Hernia, Abdominal", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M3777", "name"=>"Ethanol", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE", "maskingDescription"=>"Statistical analyses will be conducted blinded."}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Randomised parallel design using block randomisation. Stratification for centre and number of SNAP factors (one, two, or ≥ 3)."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>400}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-03-04", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2028-03-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-20", "studyFirstSubmitDate"=>"2024-02-13", "studyFirstSubmitQcDate"=>"2024-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-03-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Postoperative length of stay", "timeFrame"=>"From surgery until 30 days postoperative", "description"=>"Descriptively reported as total time in hospital within 30 postoperative days with 95% CI"}, {"measure"=>"Readmission", "timeFrame"=>"90 days", "description"=>"Descriptively reported as number and proportion (in %) of participants with readmission with 95% CI"}, {"measure"=>"Time back to work/usual activities", "timeFrame"=>"30 days, 3 months, 6 months", "description"=>"Descriptively reported, patient reported"}, {"measure"=>"Hernia recurrence", "timeFrame"=>"90 days", "description"=>"Descriptively reported as number and proportion of participants with hernia recurrence"}, {"measure"=>"Reoperation for hernia recurrence", "timeFrame"=>"90 days", "description"=>"Descriptively reported as number and proportion (in %) of participants reoperated for hernia recurrence with 95% CI"}, {"measure"=>"Visits to primary care", "timeFrame"=>"30 days", "description"=>"Descriptively reported as number and proportion (in %) of participants with any visits to primary care with 95% CI"}, {"measure"=>"Successful quitting of risky lifestyles individually", "timeFrame"=>"End of intervention/at surgery, 30 days, 3 months, 6 months", "description"=>"Descriptively reported as number and proportion (in%) of participants without their preoperative risky lifestyle (identified at baseline) with 95% CI. Each lifestyle is reported separately. Successful quitting of risky lifestyles are defined as:\n\n* Smoking: no use of any tobacco products\n* Malnutrition: not at risk of malnutrition defined as NRS \\<3\n* Obesity: 5-10 % loss of body fat mass compared to baseline\n* Alcohol: Zero alcohol intake at end of intervention/surgery and below risky limits (\\<14 units per week) at postoperative follow-ups\n* Physical inactivity: being physically active at least 3.5 hours per week"}, {"measure"=>"Change in ASA score", "timeFrame"=>"End of intervention/at surgery, 30 days, 3 months, 6 months", "description"=>"Descriptively reported as number and proportion (in %) of participants with change in ASA score level compared with baseline related to a change in risky SNAP factors with 95% CI"}, {"measure"=>"Change of frailty", "timeFrame"=>"End of intervention/at surgery, 30 days, 3 months, 6 months", "description"=>"Descriptively reported as number and proportion (in %) of participants with change in frailty score compared with baseline with 95% CI. Measured by Fried's Modified Frailty Score."}, {"measure"=>"Morbidity", "timeFrame"=>"2 years", "description"=>"Descriptively reported as grouped diagnoses via the Danish version of ICD-10 based on data from the Danish National Patient Registry."}], "primaryOutcomes"=>[{"measure"=>"Postoperative complications within 30 days", "timeFrame"=>"30 days", "description"=>"Number and proportion of participants with at least one postoperative complication defined by requiring treatment"}], "secondaryOutcomes"=>[{"measure"=>"Postoperative complications within 3 and 6 months", "timeFrame"=>"3 months, 6 months", "description"=>"Number and proportion of participants with at least one postoperative complication defined by requiring treatment"}, {"measure"=>"Comprehensive Complication Index (CCI)", "timeFrame"=>"30 days, 3 months, 6 months", "description"=>"Calculated from the Clavien-Dindo classification of the postoperative complications"}, {"measure"=>"Successful quitting of risky lifestyles", "timeFrame"=>"End of intervention/at surgery, 30 days, 3 months, 6 months", "description"=>"Number and proportion of participants without all of their preoperative risky lifestyles (identified at baseline). Successful quitting of risky lifestyles are defined as:\n\n* Smoking: no use of any tobacco products\n* Malnutrition: not at risk of malnutrition defined as NRS \\<3\n* Obesity: 5-10 % loss of body fat mass compared to baseline\n* Alcohol: Zero alcohol intake at end of intervention/surgery and below risky limits (\\<14 units per week) at postoperative follow-ups\n* Physical inactivity: being physically active at least 3.5 hours per week"}, {"measure"=>"Any improvement of risky lifestyles", "timeFrame"=>"End of intervention/at surgery, 30 days, 3 months, 6 months", "description"=>"Number and proportion of participants with any improvement of any of their risky lifestyles compared with baseline. Any improvements include:\n\n* Smoking: a reduced number of cigarettes\n* Malnutrition: improvement in level of malnutrition (NRS scale)\n* Obesity: any loss of body fat mass\n* Alcohol: a reduced alcohol intake weekly (reduced number of units weekly)\n* Physical inactivity: Any improvement in minutes of daily physical activity"}, {"measure"=>"Health-Related Quality of Life (HRQoL)", "timeFrame"=>"End of intervention/at surgery, 30 days, 3 months, 6 months", "description"=>"Number and proportion of patients with improvement of HRQoL compared with baseline. HRQoL is measured by the EQ-5D instrument"}, {"measure"=>"Costs", "timeFrame"=>"30 days, 6 months, 2 years", "description"=>"Measured as individual direct and indirect healthcare costs per patient based on data from national registries"}, {"measure"=>"Cost-effectiveness", "timeFrame"=>"2 years", "description"=>"Calculated as a probability in percent (%)"}, {"measure"=>"Patient expectations", "timeFrame"=>"Baseline", "description"=>"Measured as a number on a VAS scale from 0-10"}, {"measure"=>"Patient reflections 1", "timeFrame"=>"Baseline", "description"=>"Qualitative analysis of patients reflections on advantages and disadvantages of changing or continuing current lifestyle"}, {"measure"=>"Patient reflections 2", "timeFrame"=>"Baseline", "description"=>"Qualitative analysis of patient reflections obtained from semi-structured interviews"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Ventral Hernia", "Surgery", "Risk Reduction", "Postoperative Complications", "Prehabilitation", "Smoking", "Alcohol drinking", "Obesity", "Malnutrition", "Physical Inactivity"], "conditions"=>["Ventral Hernia", "Surgery", "Risk Reduction", "Lifestyle", "Postoperative Complications", "Prehabilitation"]}, "descriptionModule"=>{"briefSummary"=>"The five risky lifestyles Smoking, Nutrition (obesity and malnutrition), risky Alcohol intake, and Physical inactivity (SNAP) are common in surgical patients and associated with worse postoperative outcomes. Mono-factor interventions targeting and improving these risky lifestyles have been shown to reduce the risk at surgery, but there is a lack of systematic assessment of all five lifestyles of the patient before surgery and related optimization.\n\nThis study aims to evaluate the effect of intensive combined lifestyle interventions (the STRONG programme) compared with treatment as usual in patients undergoing ventral hernia repair on postoperative complications, health, and costs on short and longer term.\n\nThe hypothesis is that the STRONG programme will halve the complication rates within 30 days.", "detailedDescription"=>"This study is a multicentre randomised controlled trial. A total of 400 participants with one or more of the five risky SNAP lifestyles will be randomised to either the STRONG programme (a prehabilitation intervention) or treatment as usual preoperatively (control). The STRONG programme is individually tailored to the needs of the participants. The program contains education, motivational, and pharmaceutical support. All participants will be followed up at the end of the intervention/at surgery, one, three, and six months after surgery. Long-term outcomes are followed up from national registers two years after surgery.\n\nInterim analysis will be employed."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Participants ≥18 years scheduled for ventral hernia repair (defect smaller than 8cm)\n* Enough time for at least 4 weeks of prehabilitation\n* Screened positive for at least 1 risky SNAP factor\n* Signed informed consent\n\nExclusion Criteria:\n\n* Ventral hernia repairs with defect larger than 8 cm\n* Pregnancy/breastfeeding\n* Allergy/other contradiction to pharmaceutical and/or nutritional support\n* Contradiction to exercise\n* Previous complicated alcohol withdrawal symptoms (delirium or seizures)\n* Not able to participate in intervention due to psychiatric ilness"}, "identificationModule"=>{"nctId"=>"NCT06611462", "acronym"=>"STRONG-Hernia", "briefTitle"=>"STRONG for Surgery & Strong for Life - Intensive Prehabilitation for Risk Reduction in Ventral Hernia Repair", "organization"=>{"class"=>"OTHER", "fullName"=>"Bispebjerg Hospital"}, "officialTitle"=>"Effect of Tailored, Intensive Prehabilitation for Risky Lifestyles Before Ventral Hernia Repair on Postoperative Outcomes, Health, and Costs - a Randomised Controlled Trial (STRONG-Hernia)", "orgStudyIdInfo"=>{"id"=>"H-23028872"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Prehabilitation", "description"=>"Intervention (the STRONG programme): At least six counselling sessions (around one per week) prior to surgery as an integrated prehabilitation programme tailored to the individual patient's need for risk reduction at surgery based on a baseline screening for risky SNAP factors. It is delivered via the surgical \"Engage in the process of change\". The smoking cessation intervention follows the Gold Standard Programme and a similar structure has been used for alcohol cessation, physical exercise, and nutrition interventions. All participants in the intervention group will receive immunonutrition in the days before surgery.", "interventionNames"=>["Behavioral: Prehabilitation (the STRONG programme)"]}, {"type"=>"NO_INTERVENTION", "label"=>"Treatment as usual", "description"=>"Treatment as usual in the preoperative period in the included hospital departments, e.g. brief counselling/advice regarding smoking cessation and weight loss, and handing out the national folders on smoking and surgery. Participants are free to access support to lifestyle changes in the community."}], "interventions"=>[{"name"=>"Prehabilitation (the STRONG programme)", "type"=>"BEHAVIORAL", "otherNames"=>["Smoking cessation", "Alcohol cessation", "Physical activity", "Nutritional support for malnutrition and/or obesity"], "description"=>"Participants screened positive for one or more SNAP factors and randomised to the intervention group will receive an individualised plan for prehabilitation of their specific SNAP factors.", "armGroupLabels"=>["Prehabilitation"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"2730", "city"=>"Herlev", "status"=>"RECRUITING", "country"=>"Denmark", "contacts"=>[{"name"=>"Jacob Rosenberg, Professor, surgeon", "role"=>"CONTACT", "email"=>"jacob.rosenberg@regionh.dk", "phone"=>"+4538689504"}], "facility"=>"Copenhagen University Hospital at Herlev", "geoPoint"=>{"lat"=>55.72366, "lon"=>12.43998}}, {"zip"=>"4300", "city"=>"Holbæk", "status"=>"NOT_YET_RECRUITING", "country"=>"Denmark", "contacts"=>[{"name"=>"Birgitte Brandstrup, Associate Professor, surgeon", "role"=>"CONTACT", "email"=>"bbrn@regionsjaelland.dk", "phone"=>"+4523476009"}], "facility"=>"Holbaek Sygehus", "geoPoint"=>{"lat"=>55.71354, "lon"=>11.7169}}, {"zip"=>"4600", "city"=>"Køge", "status"=>"NOT_YET_RECRUITING", "country"=>"Denmark", "contacts"=>[{"name"=>"Frederik Helgstrand, Associate Professor, surgeon", "role"=>"CONTACT", "email"=>"freh@regionsjaelland.dk", "phone"=>"+4523348764"}], "facility"=>"Zealand University Hospital", "geoPoint"=>{"lat"=>55.45802, "lon"=>12.18214}}], "centralContacts"=>[{"name"=>"Hanne Tønnesen, Professor MD", "role"=>"CONTACT", "email"=>"hanne.tonnesen@regionh.dk", "phone"=>"+4538163840"}, {"name"=>"Sofie AS Jensen, MD", "role"=>"CONTACT", "email"=>"sofie.anne-marie.skovbo.jensen.01@regionh.dk"}], "overallOfficials"=>[{"name"=>"Hanne Tønnesen, Professor MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"WHOCC, The Parker Institute, Bispebjerg-Frederiksberg Hospital, RegH, Copenhagen"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Bispebjerg Hospital", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Copenhagen University Hospital at Herlev", "class"=>"OTHER"}, {"name"=>"Zealand University Hospital", "class"=>"OTHER"}, {"name"=>"Holbaek Sygehus", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Clinical Professor, MD", "investigatorFullName"=>"Hanne Tonnesen", "investigatorAffiliation"=>"Bispebjerg Hospital"}}}}
