Trials / Completed
CompletedNCT03598231
Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome
Prospective Randomized Cross-over Trial to Assess the Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome. SANLARS Trial (SAcral Neuromodulation for Low Anterior Resection Syndrome)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sacral 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. |
Timeline
- Start date
- 2018-05-25
- Primary completion
- 2021-02-17
- Completion
- 2022-02-17
- First posted
- 2018-07-26
- Last updated
- 2022-03-25
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT03598231. Inclusion in this directory is not an endorsement.