Low Anterior Resection Syndrome, Sacral Neuromodulation - Interstim Therapy, Rectal Cancer
Conditions
Brief summary
Low anterior resection syndrome (LARS) is a complex disorder suffered by patients who undergo rectal resection mainly due to rectal cancer. It is characterized by fecal incontinence, fragmented defecation, constipation, defecatory urgency among others, which induce an impairment in quality of life. LARS treatment armamentarium is scarce and with no long-term relief, being a difficult challenge for surgeons. There is evidence showing that sacral neuromodulation (SNM) improves patients' symptoms and quality of life. However, no prospective randomized studies have supported this improvement. This is a prospective randomized cross-over study which evaluates the effectiveness of SNM in LARS, specifically analyzing intestinal, urinary, sexual symptoms as well as quality of life.
Interventions
DEVICESacral neuromodulation
After the definitive implantation, stimulators are placed in position OFF for the first arm and in position ON for the second arm during 4 weeks. Then all the stimulators are switched OFF (both first and second arms) for 2 weeks. Finally stimulators are maintained in position ON for the first arm and switched OFF for the second arm during 4 weeks. Since this is a cross-over study, patients can be randomly assigned to any arm first, but they will go to the other arm since the patient is its own control. 50% of randomized patients will go through ON-OFF and the other 50% OFF-ON. After this cross-over phase, ALL stimulators will be in ON position until the end of the study period.
Sponsors
Hospital Universitari de Bellvitge
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Cross-over of two sequences (2x2: AB / BA)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who have had an anterior rectal resection with sphincter preservation by any approach, with or without preoperative radiotherapy. * Patients with symptomatology of major anterior resection syndrome (\>29 points on LARS score) including fecal incontinence, defecatory urgency, fecal fragmentation. * Period greater than one year since the last definitive surgery (rectal resection or ileostomy closure). * Period longer than one year in cases in which any other type of therapy has been performed for the anterior resection syndrome (for example: biofeedback, posterior tibial stimulation, physiotherapy, etc).
Exclusion criteria
* Patients who refuse to sign informed consent or are unable to understand the study. * Patients with progression of the oncological disease. * Patients in initial stage IV (metastatic). * Patients with inflammatory bowel disease. * Patients with known irritable bowel prior to rectal surgery. * Patients who have undergone resection of other intestinal segments. * Patients with systemic neurological diseases with involvement of long pathways or spinal cord injury.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Responders of Low Anterior Resection Syndrome | 3 months | Low Anterior Resection Syndrome Score (LARS Score). This is a validated specific score for low anterior resection syndrome which ranges from 0 points (normal - best score) to 42 point (LARS major - worst score). Patients should achieve 50% reduction from basal score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal incontinence | 3 months, 6 months and 12 months | Fecal continence will be assessed by the St Mark's-Vaizey continence scale, ranging from 0 points (normal - no incontinence, best result) to 24 points (total incontinence, worst result). Changes will be compared to basal data |
| Quality of life in patients with cancer | 6 months and 12 months | Validated Quality of life Quality of life questionnaire score developed by the European Organization for Research and Treatment of Cancer (EORTC) named QLQ-C30, which assesses function, symptoms and global health status of cancer patients. All of the scales and single-item measures range in score from 0 to 100 points. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. Changes will be compared to basal data |
| Sexual function | 6 months and 12 months | Sexual function will be assessed by validated scales according to patient gender. Males: International Index of Erectile Function (or IFE scale) - Score ranges from 5 to 25 points. A higher score corresponds to normal erectile function. Female: Female sexual function Index (or FSFI scale) - Minimal score 2 points. Maximum score 36 points. A higher score corresponds to sexual dysfunction. Changes will be compared to basal data |
| Urinary function | 6 months and 12 months | Urinary incontinence will be assesed by the International Consultation on Incontinence Questionnaire Short Form (or ICIQ-SF). Scale ranges from 0 to 21 points. Any value above 0 points means urinary incontinence. A higher value corresponds to worse urinary incontinence. Changes will be compared to basal data. |
Countries
Spain
Outcome results
None listed