Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome

NCT ID: NCT03598231

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-25
• Study Completion Date: 2022-02-17

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm OFF-ON

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.

Group Type: SHAM_COMPARATOR

Sacral neuromodulation

Intervention Type: DEVICE

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.

Arm ON-OFF

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.

Group Type: ACTIVE_COMPARATOR

Sacral neuromodulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

InterStim Therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari de Bellvitge

OTHER

Sponsor Role: collaborator

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

OTHER

Sponsor Role: collaborator

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Franco Marinello, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Vall d'Hebrón

Locations

Hospital Universitari Vall d'Hebrón Research Institute

Barcelona, , Spain

Countries

Spain

Other Identifiers

SANLARS

Identifier Type: -

Identifier Source: org_study_id