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NCT Number: NCT03598231

Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome

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.

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Key information

Conditions

Low Anterior Resection Syndrome Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Cancer Rectal Diseases Rectal Neoplasms Sacral Neuromodulation - Interstim Therapy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Vall d'Hebrón Research Institute

Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: InterStim Therapy

Primary outcomes

  1. Proportion of Responders of Low Anterior Resection Syndrome

    Time frame: 3 months

    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.

  2. Proportion of Responders of Low Anterior Resection Syndrome

    Time frame: 6 months

    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.

  3. Proportion of Responders of Low Anterior Resection Syndrome

    Time frame: 12 months

    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.

Secondary outcomes

  1. Fecal incontinence

    Time frame: 3 months, 6 months and 12 months

    Fecal continence will be assessed by the St Mark's-Vaizey continence scale, ranging from 0 points (normal - no incontinence, best result) to 24 points (total incontinence, worst result).

    Changes will be compared to basal data

  2. Quality of life in patients with cancer

    Time frame: 6 months and 12 months

    Validated Quality of life Quality of life questionnaire score developed by the European Organization for Research and Treatment of Cancer (EORTC) named QLQ-C30, which assesses function, symptoms and global health status of cancer patients.

    All of the scales and single-item measures range in score from 0 to 100 points. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    Changes will be compared to basal data

  3. Sexual function

    Time frame: 6 months and 12 months

    Sexual function will be assessed by validated scales according to patient gender.

    Males: International Index of Erectile Function (or IFE scale) - Score ranges from 5 to 25 points. A higher score corresponds to normal erectile function.

    Female: Female sexual function Index (or FSFI scale) - Minimal score 2 points. Maximum score 36 points. A higher score corresponds to sexual dysfunction.

    Changes will be compared to basal data

  4. Urinary function

    Time frame: 6 months and 12 months

    Urinary incontinence will be assesed by the International Consultation on Incontinence Questionnaire Short Form (or ICIQ-SF).

    Scale ranges from 0 to 21 points. Any value above 0 points means urinary incontinence. A higher value corresponds to worse urinary incontinence.

    Changes will be compared to basal data.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

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

Registry information

Official study title

Prospective Randomized Cross-over Trial to Assess the Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome. SANLARS Trial (SAcral Neuromodulation for Low Anterior Resection Syndrome)

Acronym: SANLARS

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jul 26, 2018
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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