No registrations found.
ID
Source
Brief title
Health condition
Rectal cancer; pelvic floor rehabilitation (PFR); fecal incontinence, Low Anterior Resection Syndrome (LARS), low anterior resection, TME.
Sponsors and support
Other institutions invited
Intervention
Outcome measures
Primary outcome
- Wexner-score
- Fecal Incontinence Quality of Life score (FIQL)
Secondary outcome
- EORTC Colorectal Quality of Life Questionnaire QLQ-CR38
- defecation diary
- LARS-score
- preoperative radiotherapy or radiochemotherapy
- perioperative parameters
- level of anastomosis
- morbidity and mortality related to surgery
Background 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. A two-armed randomized controlled trial will be conducted in patients who underwent sphincter-preserving rectal cancer surgery. This trial aimed to evaluate the incremental effect of PFR on the functional outcomes in patients after sphincter-preserving rectal cancer surgery. 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.
Study objective
Improving functional outcomes in rectal cancer surgery by a pelvic floor rehabilitation program.
Study design
- Preoperative questionnaires
- 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)
Intervention
Pelvic floor rehabilitation after low anterior resection for rectal cancer, including pelvic floor muscle training, biofeedback, electrostimulation and rectal balloon training.
Inclusion criteria
- Patients undergoing a low anterior resection 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.
- Not mastering the Dutch language.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5368 |
| NTR-old | NTR5469 |
| Other | : 80-84300-98-72021 |