Low Anterior Resection Syndrome (LARS)
Conditions
Brief summary
A randomized, prospective, multicenter, open-label, pragmatic pilot study of patients with Low Anterior Resection Syndrome treated early (\<120 days after discharge following intestinal bypass reconstruction) with sacral nerve root neuromodulation, compared with another group receiving personalized conservative treatment as performed in routine clinical practice.
Interventions
DEVICESacral neuromodulation
Sacral neuromodulation implantation within 120 days from discharge following rectal surgery or bowel reconstruction (ileostomy closure)
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (18 years of age or older) who are capable of signing the appropriate informed consent form. * Patients who have undergone an anterior rectal resection for rectal cancer, with an anastomosis, whether or not they have received neoadjuvant therapy, and who have bowel function, either via a direct anastomosis or following reconstruction of a lateral ileostomy. * Patients who experience more than 6 episodes of urgency and/or incontinence in the following two weeks after the screening visit, as recorded in a daily bowel diary. * Patients with a LARS score \>21 points (major or minor LARS). * Patients who report at least one symptom and one consequence as defined by the international definition.
Exclusion criteria
* Metastatic disease at the time of surgery. * Need for adjuvant chemotherapy at the time of assessment. * Active chemotherapy. * Patients with an ileostomy. * Intellectual or language-related difficulty in answering the questionnaires. * Refusal to participate in the study or failure to commit to follow-up visits. * Patients with contraindications for sacral neuromodulation implantation (those with pacemakers, active infections, or allergies to prosthetic materials). * Patients with active inflammatory bowel disease at the time of surgery. * Patients who have undergone other intestinal resections in addition to rectal resection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate bowel function in terms of at least a 50% improvement in episodes of urgency and/or incontinence due to LARS, as measured by a two-week bowel diary, following early NMS implantation compared with personalized conservative treatment. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Assess changes in the fragmentation component of the syndrome as recorded in the patient's daily bowel movement diary. | 6 months |
| Assess changes in stool consistency as recorded in the patient's daily bowel movement diary. | 6 months |
| Assess changes in soiling episodes as recorded in the patient's daily bowel movement diary. | 6 months |
| Assess changes in symptoms and outcomes as defined by the International Consensus Definition of LARS. | 6 months |
| Assess changes in bowel function in both groups using patient's daily bowel function and quality-of-life scales: the LARS score (Low Anterior Resection Syndrome Score), which divides patients in three groups: 0-20 No LARS; 21-29: Mild LARS; 30-42: Severe | 6 months |
| Assess changes in bowel function in both groups using patient's daily bowel function and quality-of-life scales: the Vaizey score, which measures the presence and severity of incontinence assigning a score from 0 (meaning complete continence) to 24 (mean | 5 years |
| Assess changes in bowel function in both groups using patient's daily bowel function and quality-of-life scales: ad hoc scale. The minimum value for the scale is 0 (meaning the worst health the patient can imagine) and the maximum value is 100 (meaning t | 6 months |
| Analyze subjective clinical improvement as assessed by patients using PGI-I scale (Patient Global Impression of Improvement). It consists of the answer to a question choosing one of 7 options from "1=Much better" to "7=Much worst". | 6 months |
| Examine changes in urinary and sexual function, analyzed by gender and specific scale. For male, the IIEF-5 (Índice Internacional De Función Erectil) will be used, which assesses erectile dysfunction from 5 (severe) to 25 (healthy). For female, The Rec | 6 months |
Countries
Spain
Outcome results
None listed