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NCT Number: NCT07761884

Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.

A randomized, prospective, multicenter, open-label, pragmatic pilot study of patients with Low Anterior Resection Syndrome treated early (<120 days after discharge following intestinal bypass reconstruction) with sacral nerve root neuromodulation, compared with another group receiving personalized conservative treatment as performed in routine clinical practice.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vall d'Hebron Barcelona Hospital Campus

Barcelona, Catalonia, 08035, Spain

Location contact

Franco Marinello, Dr.

CONTACT

[email protected]

+34 934896587

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (18 years of age or older) who are capable of signing the appropriate informed consent form.
  • Patients who have undergone an anterior rectal resection for rectal cancer, with an anastomosis, whether or not they have received neoadjuvant therapy, and who have bowel function, either via a direct anastomosis or following reconstruction of a lateral ileostomy.
  • Patients who experience more than 6 episodes of urgency and/or incontinence in the following two weeks after the screening visit, as recorded in a daily bowel diary.
  • Patients with a LARS score >21 points (major or minor LARS).
  • Patients who report at least one symptom and one consequence as defined by the international definition.

Exclusion criteria

  • Metastatic disease at the time of surgery.
  • Need for adjuvant chemotherapy at the time of assessment.
  • Active chemotherapy.
  • Patients with an ileostomy.
  • Intellectual or language-related difficulty in answering the questionnaires.
  • Refusal to participate in the study or failure to commit to follow-up visits.
  • Patients with contraindications for sacral neuromodulation implantation (those with pacemakers, active infections, or allergies to prosthetic materials).
  • Patients with active inflammatory bowel disease at the time of surgery.
  • Patients who have undergone other intestinal resections in addition to rectal resection.

Treatment and study plan

Sacral Neuromodulation

Device

Sacral neuromodulation implantation within 120 days from discharge following rectal surgery or bowel reconstruction (ileostomy closure)

Primary outcomes

  1. To evaluate bowel function in terms of at least a 50% improvement in episodes of urgency and/or incontinence due to LARS, as measured by a two-week bowel diary, following early NMS implantation compared with personalized conservative treatment.

    Time frame: 6 months

Secondary outcomes

  1. Assess changes in the fragmentation component of the syndrome as recorded in the patient's daily bowel movement diary.

    Time frame: 6 months

  2. Assess changes in stool consistency as recorded in the patient's daily bowel movement diary.

    Time frame: 6 months

  3. Assess changes in soiling episodes as recorded in the patient's daily bowel movement diary.

    Time frame: 6 months

  4. Assess changes in symptoms and outcomes as defined by the International Consensus Definition of LARS.

    Time frame: 6 months

  5. Assess changes in bowel function in both groups using patient's daily bowel function and quality-of-life scales: the LARS score (Low Anterior Resection Syndrome Score), which divides patients in three groups: 0-20 No LARS; 21-29: Mild LARS; 30-42: Severe

    Time frame: 6 months

  6. Assess changes in bowel function in both groups using patient's daily bowel function and quality-of-life scales: the Vaizey score, which measures the presence and severity of incontinence assigning a score from 0 (meaning complete continence) to 24 (mean

    Time frame: 5 years

  7. Assess changes in bowel function in both groups using patient's daily bowel function and quality-of-life scales: ad hoc scale. The minimum value for the scale is 0 (meaning the worst health the patient can imagine) and the maximum value is 100 (meaning t

    Time frame: 6 months

  8. Analyze subjective clinical improvement as assessed by patients using PGI-I scale (Patient Global Impression of Improvement). It consists of the answer to a question choosing one of 7 options from "1=Much better" to "7=Much worst".

    Time frame: 6 months

  9. Examine changes in urinary and sexual function, analyzed by gender and specific scale. For male, the IIEF-5 (Índice Internacional De Función Erectil) will be used, which assesses erectile dysfunction from 5 (severe) to 25 (healthy). For female, The Rec

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome: a Randomized, Multicenter, Prospective, Open-label, Pragmatic Study.

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

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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