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

NCT07761884 | Not Yet Recruiting

• 1 other identifier: E-SANLARS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Anterior Resection Syndrome (LARS)

Outcome Measures

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.

  6 months

Secondary Outcomes (9)

• 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

Study Arms (2)

Sacral neuromodulation

EXPERIMENTAL

Device: Sacral neuromodulation

Personalized conservative treatment

NO INTERVENTION

Interventions

Sacral neuromodulation DEVICE

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

Sacral neuromodulation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Vall d'Hebron Barcelona Hospital Campus

Barcelona, Catalonia, 08035, Spain

Location

MeSH Terms

Conditions

Low Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 12, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: August 12, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)