ID
Bron
Aandoening
- Maagdarmstelselneoplasmata maligne en niet-gespecificeerd
Aandoening
rectal cancer, bowel symptoms (fecal incontinence, urgency, frequency, fragmented defecation, soiling), Low Anterior Resection Syndrome
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
- Bewegingstherapie
Uitkomstmaten
Primaire uitkomstmaten
"Low anterior resection score (LARS): Alle uitkomstmaten werden beoordeeld op 1, 4, 6 en 12 maanden na sluiting van TME/stoma. De primaire uitkomst was gedefinieerd als het percentage deelnemers met een verbetering van de de LARS-categorie na 4 maanden (van grote LARS tot kleine LARS, van grote LARS naar geen LARS, of van kleine LARS naar geen LARS) vergeleken met de LARS-score gemeten na 1 maand postoperatief. De primaire uitkomst was de dichotome classificatie van de verandering in de LARS-categorie (1: verandering in categorie, 0: geen verandering in categorie)."
Secundaire uitkomstmaten
"De LARS-score zelf (continue variabele) werd geregistreerd als een secundaire uitkomst.
Andere secundaire uitkomsten waren darmsymptomen geëvalueerd door (1) de COREFO-vragenlijst,6 (2) een numerieke beoordelingsschaal (NRS) met betrekking tot de subjectieve last van darmsymptomen, en (3) een ontlastingsdagboek. Een 7-daags ontlastingsdagboek beoordeelde frequentie van stoelgang, consistentie van de ontlasting (gescoord op de Bristol Stool
Schaal), urgentie/incontinentie/vervuiling, fragmentatie van ontlasting (clustering). De kwaliteit van leven werd geëvalueerd door de Short Form-12 (SF-12).
Fysieke activiteit werd geëvalueerd m.b.v. de Flemisch Physical Activity Computerized Questionnaire (FPACQ). "
Onderzoeksopzet
Preoperative assessment of bowel symptoms, urinary symptoms, sexual symptoms, physical activity Assessment at 4 weeks after surgery/closure ileostomy (start PFMT for the intervention group) and at 16 weeks (primary endpoint) after surgery/closure ileostomy (end PFMT): bowel symptoms, urinary symptoms, sexual symptoms, physical activity, muscle tone/force/endurance pelvic floor muscles Follow-up assessments after 6 and 12 months: bowel symptoms, urinary symptoms, sexual symptoms, physical activity, tone/strength/endurance pelvic floor muscles Study outcomes: Control group + intervention group: LARS-score, Colorectal Functional Outcome Questionnaire, International Consulation on Incontinence Questionnaire, Female Sexual Function Index/ Interternational Index of Erectile Function, Flemish Physical Activity Questionnaire, Numeric Rating Scale, Bowel Diary, Bladder Diary, 1 hour Pad test, Evaluation pelvic floor muscles (tone, strength, endurance) Intervention group: pelvic floor muscle training (9 times in 12 weeks)
Onderzoeksproduct en/of interventie
Bekkenbodemspiertraining
Publiek
Inge Geraerts
Katholieke Universiteit Leuven
Faculteit Bewegings- en Revalidatiewetenschappen
Tervuursevest 101
Leuven 3001
Belgium
+32 16329120
inge.geraerts@faber.kuleuven.be
Wetenschappelijk
Inge Geraerts
Katholieke Universiteit Leuven
Faculteit Bewegings- en Revalidatiewetenschappen
Tervuursevest 101
Leuven 3001
Belgium
+32 16329120
inge.geraerts@faber.kuleuven.be
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- patients planned for a low anterior resection for rectal cancer (TME, total mesorectal excision)
- patients who have an expected survival of at least 1.5 years
- patients who are able to come to the hospital once a week during the complete treatment period (12 weeks)
- patients with a minimal LARS score of 21/42
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- having a HARTMANN procedure, abdominiperineal excision or transanal microsurgical resection or sigmoïd resection
- patients with neurological conditions
- patients with cognitive problems
- patients with preoperative fecal incontinence
- patients who have had precious pelvic surgery, previous pelvic radiation or LAR for non-cancer reasons
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL6227 |
NTR-old | NTR6383 |
Ander register | Number Ethical Committee of University Hospitals Leuven S59761 |
Samenvatting resultaten
A 2nd study was conducted to investigate whether bowel symptoms related to LAR for RC could be sufficiently well evaluated by the LARS-questionnaire or the COREFO-questionnaire, compared to the stool diary. Patients were asked to fill out the stool diary and the LARS- and COREFO-questionnaire at 1, 4, 6 and 12 months after TME/stoma closure. Data from a subgroup of 95 patients of the previously mentioned RCT was analysed. Following items were significantly correlated between the LARS-/COREFO-questionnaire and the stool diary: anal incontinence for faeces and frequency of bowel movements. Furthermore, items on soiling were significantly correlated between the COREFO-questionnaire and the stool diary. No significant association was found with the information provided by the stool diary for either questionnaire on items on clustering of bowel movements and urgency. Lastly, overall moderate associations were found between the questionnaires and the stool diary, although the amount of overlapping information was rather limited.
Finally the progression of all PA levels (total, sport, occupational and household) was investigated over time, together with the exploration of possible predictive factors for a decrease in those PA levels. Patients were asked to fill out the Flemish Physical Activity Computerized Questionnaire (FPACQ) and the LARS- and COREFO-questionnaire regarding the preoperative period and at 1, 4, 6 and 12 months after TME/stoma closure. Results from the 125 included RC patients showed that total physical activity levels remained significantly lower than preoperative values up to 12 months postoperatively. Furthermore, occupational and sports physical activity levels remained significantly lower until 6 and 4 months postoperative, respectively. Predictive factors for decreased physical activity levels at a specific timepoint were: younger age and no stoma (total physical activity, 1 month), low/mid rectal tumour, no stoma, non-employed status (total, 4 months), higher COREFO-scores (occupational, 4 months) and non-employed status (total, 12 months)."