|- candidate number||22413|
|- NTR Number||NTR5470|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-jul-2015|
|- Secondary IDs||80-84300-98-72021 |
|- Public Title||Pelvic Floor rehabilitation to improve functional Outcome and quality of life after transanal TME for Rectal CancEr: a randomized trial.|
|- Scientific Title||Pelvic Floor rehabilitation to improve functional Outcome and quality of life after transanal TME for Rectal CancEr: a randomized trial.|
|- ACRONYM||FORCE II|
|- hypothesis||Improving functional outcomes after transanal TME by a pelvic floor rehabilitation program.|
|- Healt Condition(s) or Problem(s) studied||Rectal cancer, Rectal resection for rectal carcinoma, Fecal incontinence|
|- Inclusion criteria||- Patients undergoing a taTME for rectal cancer.|
- Age over 18 years.
|- Exclusion criteria||- 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.
|- mec approval received||no|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2016|
|- planned closingdate||1-jul-2017|
|- Target number of participants||112|
|- Interventions||Pelvic floor rehabilitation after taTME for rectal cancer, including pelvic floor muscle training, biofeedback, electrostimulation and rectal balloon training.|
|- Primary outcome||- Wexner-score|
- Fecal Incontinence Quality of Life score (FIQL)
|- Secondary outcome||- EORTC Colorectal Quality of Life Questionnaire QLQ-CR38|
- defecation diary
- preoperative radiotherapy or radiochemotherapy
- perioperative parameters
- level of anastomosis
- morbidity and mortality related to surgery
|- Timepoints||- 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)
|- Trial web site||follows|
|- CONTACT FOR PUBLIC QUERIES||MD. B.R. Klarenbeek|
|- CONTACT for SCIENTIFIC QUERIES||MD. B.R. Klarenbeek|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Isala Clinics Zwolle, Medisch Centrum Leeuwarden (MCL)|
(Source(s) of Monetary or Material Support)
|- Publications||Wilhelmina S Visser, Wouter W te Riele, Djamila Boerma, Bert van Ramshorst,
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.
|- Brief summary||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.|
|- Main changes (audit trail)|
|- RECORD||3-jul-2015 - 23-dec-2015|