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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Anterior Resection Syndrome (LARS)
• Intervention / Treatment: Device: Sacral neuromodulation

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08035
      • Vall d'Hebron Barcelona Hospital Campus
      • Contact: Franco Marinello, Dr.; Phone Number: +34 934896587; Email: franco.marinello@vallhebron.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sacral neuromodulation	Device: Sacral neuromodulation; Sacral neuromodulation implantation within 120 days from discharge following rectal surgery or bowel reconstruction (ileostomy closure)
No Intervention: Personalized conservative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Assess changes in the fragmentation component of the syndrome as recorded in the patient's daily bowel movement diary.	6 months
Assess changes in stool consistency as recorded in the patient's daily bowel movement diary.	6 months
Assess changes in soiling episodes as recorded in the patient's daily bowel movement diary.	6 months
Assess changes in symptoms and outcomes as defined by the International Consensus Definition of LARS.	6 months
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	6 months
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	5 years
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	6 months
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".	6 months
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	6 months

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: July 27, 2026
• First Submitted That Met QC Criteria: August 10, 2026
• First Posted (Actual): August 12, 2026

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Low Anterior Resection Syndrome
• Other Study ID Numbers: E-SANLARS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No