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2023-12-11

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Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/212229

Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome: The SANLARS Randomized Clinical Trial

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https://doi.org/10.1097/DCR.0000000000003143

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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.

Matèries

Cirurgia colorectal, Complicacions quirúrgiques

Matèries (anglès)

Colorectal surgery, Complications of surgery

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Col·leccions

Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

Citació

MARINELLO, Franco, FRACCALVIERI, Doménico, PLANELLAS, Pere, ADELL TRAPÉ, Montse, GIL, Julia m., KREISLER, Esther, PELLINO, Gianluca, ESPÍN BASANY, Eloy. Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome: The SANLARS Randomized Clinical Trial. _Diseases of the Colon & Rectum_. 2023. Vol. 67, núm. 3, pàgs. 435-447. [consulta: 1 de febrer de 2026]. ISSN: 1530-0358. [Disponible a: https://hdl.handle.net/2445/212229]

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