Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome (SANLARS)

Vall d'Hebron University Hospital (HUVH)

Status: Completed

Conditions: Sacral Neuromodulation - Interstim Therapy; Low Anterior Resection Syndrome; Rectal Cancer

Treatments: Device: Sacral neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03598231

SANLARS

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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45 participants in 2 patient groups

Arm OFF-ON

Sham Comparator group

Description:

Patients are subjected to a test phase by stimulation with an external temporal generator and, if there is improvement in their symptomatology, a subcutaneous impulse generator for sacral neuromodulation is implanted. Once the generator is placed it will be disconnected for 4 weeks. Then it will be continued to be turned OFF for 2 weeks as a wash-out period. Then, the stimulator will be turn ON for 4 weeks and will be left on afterwards at the maximum subsensory stimulus. Specific scales will be passed after each sequence crossing.

Treatment:

Device: Sacral neuromodulation

Arm ON-OFF

Active Comparator group

Description:

Patients are subjected to a test phase by stimulation with an external temporal generator and, if there is improvement in their symptomatology, a subcutaneous impulse generator sacral neuromodulation is implanted. Once the generator is placed it will be turned ON for 4 weeks at the maximum subsensory stimulus. Then it will be turned OFF for 2 weeks as a wash-out period. Then, the stimulator will be kept OFF for 4 weeks. After this sequence it will be turned on again and will be left on afterwards at the maximum subsensory stimulus. Specific scales will be passed after each sequence crossing.

Treatment:

Device: Sacral neuromodulation