Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome

NCT03598231 | Completed DMC

• 1 other identifier: SANLARS
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Proportion of Responders of Low Anterior Resection Syndrome

  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.

  3 months

• Proportion of Responders of Low Anterior Resection Syndrome

  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 40% reduction from basal score.

  6 months

• Proportion of Responders of Low Anterior Resection Syndrome

  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 40% reduction from basal score.

  12 months

Secondary Outcomes (4)

• Fecal incontinence

  3 months, 6 months and 12 months

• Quality of life in patients with cancer

  6 months and 12 months

• Sexual function

  6 months and 12 months

• Urinary function

  6 months and 12 months

Study Arms (2)

Arm OFF-ON

SHAM COMPARATOR

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.

Device: Sacral neuromodulation

Arm ON-OFF

ACTIVE COMPARATOR

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.

Device: Sacral neuromodulation

Interventions

Sacral neuromodulation 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.

Also known as: InterStim Therapy

Arm OFF-ON; Arm ON-OFF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Hospital Universitari de Bellvitge: collaborator
• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta: collaborator

Study Sites (1)

Hospital Universitari Vall d'Hebrón Research Institute

Barcelona, Spain

Location

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Franco Marinello, MD, PhD

  Hospital Universitari Vall d'Hebrón

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-over of two sequences (2x2: AB / BA)

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: July 26, 2018
• Study Start: May 25, 2018
• Primary Completion: February 17, 2021
• Study Completion: February 17, 2022
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)