[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659527":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":29,"interventions":23,"overallOfficials":23,"centralContacts":36,"locations":42,"responsibleParty":56,"collaborators":23,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":23,"enrollmentInfo":69,"targetDuration":72,"studyType":73,"phases":23,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":82,"whyStopped":23,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Bispebjerg Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Rate of hernia recurrence","hernia recurrence following elective parastomal hernia repair","5 years",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Rate of emergency presentations","acute hernia-related complications requiring emergency care +\u002F- emergency surgery",{"measure":18,"description":19,"timeFrame":12},"Changes in stoma related quality of life","Stoma related quality of life changes over time for both patients treated conservatively and with surgery. Assessed with the stoma-related quality of life questionnare Stoma Quality of Life questionnaire (Stoma-QOL) at first visit, 3 months postoperatively for patients who undergo elective parastomal hernia repair, and subsequently once a year until 5 years for all included patients.\n\nStoma-QOL: A 20-item, stoma-specific patient-reported outcome measure assessing quality of life in patients with a colostomy or ileostomy. The total score ranges from 0 to 100, with higher scores indicating better stoma-related quality of life.",{"measure":21,"description":22,"timeFrame":12},"changes in general quality of life","Quality of life changes over time for both patients treated conservatively and with surgery. Assessed with the quality of life questionnare EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) at first visit, 3 months postoperatively for patients who undergo elective parastomal hernia repair, and subsequently once a year until 5 years for all included patients.\n\nEQ-5D-5L: A generic patient-reported measure of health-related quality of life assessing five dimensions: mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression, each rated on five levels of severity. Using the Danish EQ-5D-5L value set, responses are converted into an index value ranging from -0.757 to 1.000, where higher values indicate better health-related quality of life and 1.000 represents full health. The instrument also includes the EQ Visual Analogue Scale (EQ VAS), ranging from 0 (worst health imaginable) to 100 (best health imaginable).",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"COHORT","PROSPECTIVE","IDOPS is a prospective observational cohort and clinical registry designed to establish a longitudinal evidence base for patient selection and treatment of parastomal hernia. The registry captures the clinical pathway from initial specialist assessment through treatment decisions, reassessments, elective surgery where applicable, and emergency presentations. Treatment is determined through routine clinical care.\n\nRegistry structure and procedures\n\nData are collected in a dedicated REDCap database. The initial assessment is recorded once, while repeatable instruments capture subsequent treatment decisions, outpatient reassessments, operations, postoperative complications, acute admissions, and acute interventions. This structure allows multiple events to be recorded for each participant while preserving their chronological relationship.\n\nTreatment decisions include referral for multidisciplinary hernia discussion and the reasons for non-operative management. These distinguish between an unfavourable balance of symptom burden and surgical risk, lack of suitability for surgery, and a patient's decision to decline an offered operation. Changes in management are recorded prospectively.\n\nPatient-reported data are collected during outpatient assessments and through automated questionnaire invitations delivered via secure digital mail. Annual invitations for patients who have not undergone surgery are scheduled relative to enrolment. Postoperative invitations are scheduled relative to the first operation recorded in the registry. Invitation logic incorporates questionnaire completion status and whether follow-up remains active.\n\nData dictionary and validation\n\nThe REDCap data dictionary defines variable names, field labels, response options, coding, branching logic, required fields, and applicable validation rules. Calculated fields are used for derived variables, including body mass index and questionnaire scores. Hernia characteristics are recorded using the European Hernia Society classification, with primary and recurrent hernias distinguished.\n\nData-entry controls include predefined response categories, date validation, required fields, and numerical range checks where appropriate. For example, height and weight fields have predefined permitted ranges. Conditional fields are displayed according to preceding responses to support consistent recording of treatment decisions and clinical events.\n\nData quality assurance and source verification\n\nThe study team will review registry data for completeness, duplicate records, implausible values, inconsistent responses, and discrepancies in the chronological sequence of clinical events. Identified discrepancies will be checked against the relevant source and corrected where possible.\n\nMedical records, imaging reports, and operative reports will be used to verify clinical data when entries are incomplete, inconsistent, or uncertain. Patient-reported questionnaire responses will be retained as reported by the participant. Corrections to clinical data and changes to the database structure will be documented using REDCap's logging functionality.\n\nRegistry operations and change management\n\nThe study team will maintain documented procedures for recruitment and consent recording, data entry, follow-up administration, discrepancy resolution, data extraction, analysis, and reporting. Postoperative complications and acute events will be captured from routine clinical documentation. Database changes will be reviewed for their effects on existing records, branching logic, calculated fields, and automated invitations before implementation. Analyses will use dated data extracts and documented variable definitions.\n\nSample size considerations\n\nThe anticipated cohort size is approximately 250 participants recruited over five years, based on expected clinical volume. The study is exploratory and is not powered to test a single treatment effect. The number of participants with available follow-up and the number of observed events will determine the precision of estimates and the complexity of adjusted analyses. Development of prediction models will depend on whether sufficient data and events are available; subsequent validation would require an appropriate validation dataset.\n\nMissing data\n\nMissing data will be assessed by variable and follow-up time point. Where possible, missing clinical information will be retrieved from source records. Unavailable information will remain missing rather than being interpreted as the absence of an event. Unresolved inconsistent or implausible values will be treated as missing for the relevant analysis.\n\nQuestionnaire response rates will be reported at each scheduled assessment. Scoring will follow the applicable questionnaire instructions. Analyses will distinguish non-response from assessments that are no longer applicable because of death, withdrawal, or stoma reversal. The choice between complete-case analysis and methods such as multiple imputation will depend on the extent and likely mechanism of missingness. Material assumptions will be examined through sensitivity analyses where feasible.\n\nStatistical analysis\n\nAnalyses will describe patient characteristics, treatment pathways, operative practice, and longitudinal clinical and patient-reported data. Estimates will be presented with measures of uncertainty. Time-to-event analyses will use a clearly defined time origin appropriate to the question, such as enrolment or surgery. Death will be considered as a competing event where relevant.\n\nChanges in patient-reported scores will be analysed using methods that account for repeated measurements within participants. Multivariable analyses will explore associations between patient characteristics, treatment decisions, operative techniques, and subsequent outcomes, with model complexity limited by the available sample and event counts.\n\nPatients may transition from non-operative management to surgery during follow-up. Analyses involving treatment status will account for the timing of this transition where relevant. Comparisons between management strategies or operative techniques will be interpreted in light of confounding by indication and will not, by themselves, establish causal treatment effects.","Patients assessed in the specialist stoma outpatient clinic at Abdominalcenter K, Bispebjerg Hospital.",[30,33],{"label":31,"type":23,"description":32,"interventionNames":23},"non-operative management","patients who are not offered or do not want elective parastomal hernia repair",{"label":34,"type":23,"description":35,"interventionNames":23},"operative management","patients who undergo parastomal hernia repair",[37],{"name":38,"role":39,"phone":40,"phoneExt":23,"email":41},"Erling Oma, MD, PhD","CONTACT","004520367152","erling.oma@regionh.dk",[43],{"facility":5,"status":23,"city":44,"state":23,"zip":23,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Copenhagen","Denmark","DK",{"type":48,"coordinates":49},"Point",[50,51],12.56553,55.67594,{"lat":51,"lon":50},[54],{"name":38,"role":39,"phone":55,"phoneExt":23,"email":41},"004520367252",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"SPONSOR_INVESTIGATOR","Erling Oma","MD, PhD, ass.prof","100659527","improving-decisions-and-outcomes-in-parastomal-hernia-surgery-100659527",false,"NCT07866339","Improving Decisions and Outcomes in Parastomal Hernia Surgery","IDOPS","Inclusion Criteria:\n\n* Parastomal hernia confirmed by clinical assessment and imaging.\n* Assessed in the specialist stoma outpatient clinic at Abdominalcenter K, Bispebjerg Hospital.\n* Able to understand the oral and written participant information.\n* Provides written informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of parastomal hernia ruled out.\n* Unwilling or unable to provide informed consent.","ALL","18 Years",{"count":70,"type":71},250,"ESTIMATED","5 Years","OBSERVATIONAL","The goal of this observational study is to help improve decisions about planned surgery for parastomal hernia and understand the results of treatment. A parastomal hernia is a bulge that develops around a stoma, an opening in the abdomen created during surgery to allow bowel contents to pass into a bag. These hernias can cause discomfort, problems with stoma care, and reduced quality of life. Surgery may help, but it also carries risks, and the hernia may return.\n\nThe study will include approximately 250 patients assessed for parastomal hernia at Bispebjerg Hospital in Denmark. It will include both patients who undergo planned hernia surgery and patients who are managed without surgery.\n\nThe main questions are:\n\nWhat are the short- and long-term results of planned parastomal hernia surgery, including complications, hospital readmissions, further operations, return of the hernia, and quality of life?\n\nHow often do patients who are initially not offered planned surgery need emergency hospital care or emergency surgery?\n\nWhich patient characteristics, symptoms, and hernia features are associated with treatment decisions and outcomes?\n\nHow does quality of life change over time in patients managed with and without surgery?\n\nParticipants will receive their usual care. Decisions about treatment will be made by patients and their clinical team independently of study participation. The study does not assign treatments or require additional invasive examinations.\n\nResearchers will collect information from routine clinical assessments, imaging, medical records, and questionnaires. Participants will complete two questionnaires about stoma-related quality of life and general health, called Stoma-QOL and EQ-5D-5L, when they join the study and at subsequent outpatient assessments.\n\nParticipants will also be invited to complete the questionnaires at home through secure digital mail. Patients who have not undergone hernia surgery will receive annual invitations starting one year after joining the study. Patients who undergo planned hernia surgery will receive invitations after surgery and annually thereafter. This allows researchers to follow quality of life over time in both groups.\n\nParticipants will be followed for up to five years from joining the study. The findings may help clinicians and patients make better-informed decisions about whether to proceed with planned parastomal hernia surgery.",[76],"Parastomal Hernia",[78,79,80,81],"parastomal hernia","quality of life","patient selection","parastomal hernia repair","NOT_YET_RECRUITING","2026-10-07",{"date":85,"type":86},"2026-10-08","ACTUAL",{"date":88,"type":71},"2026-10",{"date":90,"type":71},"2036-09",{"name":58,"class":6},1]