- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07761884
Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.
10. august 2026 opdateret af: Hospital Universitari Vall d'Hebron Research Institute
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Catalonia
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Barcelona, Catalonia, Spanien, 08035
- Vall d'Hebron Barcelona Hospital Campus
-
Kontakt:
- Franco Marinello, Dr.
- Telefonnummer: +34 934896587
- E-mail: franco.marinello@vallhebron.cat
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Sacral neuromodulation
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Sacral neuromodulation implantation within 120 days from discharge following rectal surgery or bowel reconstruction (ileostomy closure)
|
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Ingen indgriben: Personalized conservative treatment
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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.
Tidsramme: 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Assess changes in the fragmentation component of the syndrome as recorded in the patient's daily bowel movement diary.
Tidsramme: 6 months
|
6 months
|
|
Assess changes in stool consistency as recorded in the patient's daily bowel movement diary.
Tidsramme: 6 months
|
6 months
|
|
Assess changes in soiling episodes as recorded in the patient's daily bowel movement diary.
Tidsramme: 6 months
|
6 months
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Assess changes in symptoms and outcomes as defined by the International Consensus Definition of LARS.
Tidsramme: 6 months
|
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
Tidsramme: 6 months
|
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
Tidsramme: 5 years
|
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
Tidsramme: 6 months
|
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".
Tidsramme: 6 months
|
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
Tidsramme: 6 months
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
1. august 2029
Studieafslutning (Anslået)
1. februar 2030
Datoer for studieregistrering
Først indsendt
27. juli 2026
Først indsendt, der opfyldte QC-kriterier
10. august 2026
Først opslået (Faktiske)
12. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. august 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- E-SANLARS
Plan for individuelle deltagerdata (IPD)
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