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Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome

NCT03598231 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-03-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Hospital Universitari de Bellvitge

    collaborator OTHER

  • Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

    collaborator OTHER

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Franco Marinello, MD, PhD · Hospital Universitari Vall d'Hebrón

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-25
Primary Completion
2021-02-17
Completion
2022-02-17

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03598231 on ClinicalTrials.gov