2026-04-14T06:35:26Zhttps://recercat.cat/oai/request

oai:recercat.cat:2445/2122292025-12-05T12:07:59Zcom_2072_1057col_2072_478916col_2072_478917

urn:hdl:2445/212229 Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome: The SANLARS Randomized Clinical Trial Marinello, Franco Fraccalvieri, Doménico Planellas, Pere Adell Trapé, Montse Gil, Julia M. Kreisler, Esther Pellino, Gianluca Espín Basany, Eloy Cirurgia colorectal Complicacions quirúrgiques Colorectal surgery Complications of surgery BACKGROUND: Sacral neuromodulation might be effective to palliate low anterior resection syndrome after rectal cancer surgery, but robust evidence is not available. OBJECTIVE: To assess the impact of sacral neuromodulation on low anterior resection syndrome symptoms as measured by validated scores and bowel diaries. DESIGN: Randomized, double-blind, 2-phased, controlled, multicenter crossover trial (NCT02517853). SETTINGS: Three tertiary hospitals. PATIENTS: Patients with major low anterior resection syndrome 12 months after transit reconstruction after rectal resection who had failed conservative treatment. INTERVENTIONS: Patients underwent an advanced test phase by stimulation for 3 weeks and received the pulse generator implant if a 50% reduction in low anterior resection syndrome score was achieved. These patients entered the randomized phase in which the generator was left active or inactive for 4 weeks. After a 2-week washout, the sequence was changed. After the crossover, all generators were left activated. MAIN OUTCOME MEASURES: The primary outcome was low anterior resection syndrome score reduction. Secondary outcomes included continence and bowel symptoms. RESULTS: After testing, 35 of 46 patients (78%) had a 50% or greater reduction in low anterior resection syndrome score. During the crossover phase, all patients showed a reduction in scores and improved symptoms, with better performance if the generator was active. At 6- and 12-month follow-up, the mean reduction in low anterior resection syndrome score was -6.2 (95% CI -8.97 to -3.43; p < 0.001) and -6.97 (95% CI -9.74 to -4.2; p < 0.001), with St. Mark's continence score -7.57 (95% CI -9.19 to -5.95, p < 0.001) and -8.29 (95% CI -9.91 to -6.66; p < 0.001). Urgency, bowel emptiness sensation, and clustering episodes decreased in association with quality-of-life improvement at 6- and 12-month follow-up. LIMITATIONS: The decrease in low anterior resection syndrome score with neuromodulation was underestimated because of an unspecific measuring instrument. There was a possible carryover effect in sham stimulation sequence. CONCLUSIONS: Neuromodulation provides symptoms and quality-of-life amelioration, supporting its use in low anterior resection syndrome. See Video Abstract. 2024-05-30T17:54:45Z 2024-05-30T17:54:45Z 2023-12-11 2024-05-10T11:28:39Z info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Reproducció del document publicat a: https://doi.org/10.1097/DCR.0000000000003143 Diseases of the Colon & Rectum, 2023, vol. 67, num. 3, p. 435-447 https://doi.org/10.1097/DCR.0000000000003143 (c) © The American Society of Colon & Rectal Surgeons, Inc, 2024 info:eu-repo/semantics/openAccess Ovid Technologies (Wolters Kluwer Health) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))