Improving functional outcomes after transanal TME by a pelvic floor rehabilitation program.
ID
Bron
Verkorte titel
Aandoening
Rectal cancer; pelvic floor rehabilitation (PFR); fecal incontinence, Low Anterior Resection Syndrome (LARS), TAMIS, transanal TME (taTME).
Ondersteuning
Other institutions invited
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Wexner-score<br>
- Fecal Incontinence Quality of Life score (FIQL)
Achtergrond van het onderzoek
It is widely accepted that 90% of patients undergoing sphincter-preserving rectal surgery, will subsequently have a change in bowel habit, ranging from increased bowel frequency to fecal incontinence or evacuatory dysfunction. The new approach for low rectal tumors, transanal total mesolectal excision (taTME), is thought to cause even more incontinence. A two-armed randomized controlled trial will be conducted in patients who underwent taTME This trial aimed to evaluate the incremental effect of PFR on the functional outcomes in patients after taTME. Patients will be randomized for standardized PFR or regular treatment. The study will be a multicenter trial in several tertiary referral centers and teaching hospitals. 56 patients will be included in each arm of the protocol. The total number of 112 patients will be included during an 18 month period and a minimal follow-up time of 1 year is necessary.
Doel van het onderzoek
Improving functional outcomes after transanal TME by a pelvic floor rehabilitation program.
Onderzoeksopzet
- Postoperative questionnaires and start of PFR 3 months after surgery (T0)
- 12 therapy sessions during 3 months
- Questionnaires after 3 months of PFR (T1)
- Questionnaires 12 months after start PFR (T2)
Onderzoeksproduct en/of interventie
Pelvic floor rehabilitation after taTME for rectal cancer, including pelvic floor muscle training, biofeedback, electrostimulation and rectal balloon training.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Patients undergoing a taTME for rectal cancer.
- Age over 18 years.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- No informed consent.
- Certain comorbidities: proctitis, colitis ulcerosa, Crohn's disease
- Necessity for resection beyond TME, ie T4 tumor.
- Previous course of pelvis radiotherapie, for other reasons then the current rectal carcinoma.
- Pelvic floor rehabilitation therapy in the last six months prior to rectal resection.
- Life expectancy less than 1 year.
- Mental or physical condition, that compromises the feasibility of the intervention.
- No master of the Dutch language.
Opzet
Deelname
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 | NL5369 |
| NTR-old | NTR5470 |
| Ander register | : 80-84300-98-72021 |
Samenvatting resultaten
Henderik L van Westreenen. Pelvic Floor Rehabilitation to Improve Functional Outcome After a Low Anterior Resection: A Systematic Review. Annals of Coloproctology 2014; 30(3):109-114.