Stoma systems are often relocated back. This is coded as “OPS 5-465.- Reversal of a double-loop enterostoma” or “OPS 5-466.- Restoration of intestinal continuity in terminal enterostomies”. et al. ICD: Z93.2 This stoma repositioning is often associated with LARS syndrome (Low Anterior Resection Syndrome). The term LARS covers various symptoms.
Conditions
Interventions
Group 1: (“Verum” Group A) Active Comparator
(5 visits in one year)
T 1 and T 5 - the following questionnaires are collected: adherence, LARS score, quality of life (EORTC QlQ-C30), distress thermomet
Sponsors
Coloplast GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age at least 18 years and full legal capacity • Signed informed consent (ICF) • Rectal resection for rectal cancer • Surgery for stoma repositioning after initial total mesorectal excision (TME) with protective stoma creation • LARS (minor/major), detected 4 weeks after hospital discharge (after stoma repositioning) • Completion of any adjuvant therapy that may have been indicated • Be able and willing to meet all study appointments as required by the protocol • Be able and willing to complete study-related documents
Exclusion criteria
Exclusion criteria: Participation in other stoma studies • UICC stage IV • Multivisceral resections • Insufficient German language skills and/or hearing loss • Pregnancy/Breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this postoperative controlled data collection from LARS patients is the evaluation of quality of life with two different follow-up concepts. The European Organization for Research and Treatment of Cancer (EORTC) questionnaire will be used as an assessment tool for quality of life. Patients will be asked to complete the QLQ-C30 questionnaire at T 1 (6 weeks after hospital discharge) and at T 5 (13 months after hospital discharge). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are presentation, development and evaluation of the LARS score and adherence to recommended therapeutic measures at defined times. The LARS score, based on 5 questions, and the adherence questionnaire are collected in the "Verum" group A on dates 1 - 5; in the “control” group B on dates 1 and 5. As exploratory endpoints, psycho-oncological data will be collected in the form of 3 questionnaires: GAD-7 (Generalized Anxiety Disorder), PHQ-8 (Patient Health Questionnaire) and the Distress Thermometer. These questionnaires are collected at T 1 and T 5 for both groups. | — |
Countries
Germany
Contacts
Public ContactAndreas Rink
Universitätsklinikum Essen (AöR), Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Outcome results
None listed