Exploring the Efficacy of the Paula Method of Muscle Exercises in Managing Low Anterior Resection Syndrome Using an Integrative Approach: A Preliminary Study.

Background: Low anterior resection syndrome (LARS) is a post-proctectomy consequence characterized by variable and unpredictable bowel function, including clustering, urgency, and incontinence, which significantly impacts the quality of life. Currently, there is no established gold-standard therapy for LARS. Primary Study Objective: This study aimed to evaluate the effectiveness of the Paula method of exercise as part of an integrative treatment approach for patients with LARS. Design: This preliminary study utilized a single-arm pretest-posttest design. Setting: The study was conducted at a tertiary care medical center. Participants: Five patients diagnosed with LARS completed the study. Intervention: Participants underwent twelve weeks of individualized Paula method exercise sessions. Two questionnaires were employed to assess the severity of LARS and quality of life. Primary Outcome Measures: (1) Low Anterior Resection Syndrome (LARS) Score; (2) Memorial Sloan Kettering Cancer Bowel Function Instrument (MSK-BFI); (3) Global Quality-of-Life (QOLS) Score . Results: All participants completing the 12-week Paula exercise regimen reported no difficulty in engaging with the exercises. Statistically significant improvements were observed in both the LARS score and MSK-BFI (P = .039 and P = .043, respectively, Wilcoxon Rank Sum test). While there were improvements in the global quality-of-life score and functional scales of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, these improvements did not reach statistical significance. Conclusions: This preliminary study suggests that patients with LARS can successfully complete a 12-week exercise program using the Paula method, resulting in improved LARS scores. However, further investigation through larger, multicenter, randomized controlled trials is necessary to establish the efficacy of these exercises as a treatment for LARS.

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

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 . NEUROMODULACIN SACRA EN PACIENTES CON SNDROME DE RESECCIN ANTERIOR BAJA ENSAYO CLNICO ALEATORIZADO SANLARS: ANTECEDENTES:La neuromodulación sacra podría ser eficaz para paliar el síndrome de resección anterior baja después de la cirugía de cáncer de recto, pero no hay pruebas sólidas disponibles.OBJETIVO:Evaluar el impacto de la neuromodulación sacra en los síntomas del síndrome de resección anterior baja, medido mediante puntuaciones validadas y diarios intestinales.DISEÑO:Ensayo cruzado multicéntrico, controlado, aleatorizado, doble ciego, de dos fases (NCT02517853).LUGARES:Tres hospitales terciarios.PACIENTES:Pacientes con puntuación de resección anterior baja importante, 12 meses después de la reconstrucción del tránsito después de la resección rectal en quienes había fracasado el tratamiento conservador.INTERVENCIONES:Los pacientes se sometieron a una fase de prueba avanzada mediante estimulación durante tres semanas y se les implantó el generador de impulsos si se lograba una reducción del 50% en la puntuación del síndrome de resección anterior baja, ingresando a la fase aleatorizada en la que el generador se dejaba activo o inactivo durante cuatro semanas. Después de observar por 2 semanas, se cambió la secuencia. Después del cruce, todos los generadores quedaron activados.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue la reducción de la puntuación del síndrome de resección anterior baja. Los resultados secundarios incluyeron continencia y síntomas intestinales.RESULTADOS:Después de las pruebas, 35 de 46 pacientes (78%) tuvieron una reducción ≥50% en la puntuación del síndrome de resección anterior baja. Durante el cruce, todos los pacientes mostraron una reducción en las puntuaciones y una mejora de los síntomas, con un mejor rendimiento si el generador estaba activo. A los 6 y 12 meses de seguimiento, la reducción media en la puntuación del síndrome de resección anterior baja fue -6,2 (-8,97; -3,43; p < 0,001) y -6,97 (-9,74; -4,2; p < 0,001), con Puntuación de continencia de St. Mark's -7,57 (-9,19; -5,95, p < 0,001) y -8,29 (-9,91; -6,66; p < 0,001). La urgencia, la sensación de vacío intestinal y los episodios de agrupamiento disminuyeron en asociación con una mejora en la calidad de vida a los 6 y 12 meses de seguimiento.LIMITACIONES:La disminución en la puntuación del síndrome de resección anterior baja con neuromodulación se subestimó debido a un instrumento de medición no específico. Posible efecto de arrastre en la secuencia de estimulación simulada.CONCLUSIONES:La neuromodulación mejora los síntomas y la calidad de vida, lo que respalda su uso en el síndrome de resección anterior baja. (Traducción-Dr. Mauricio Santamaria ).

Effect of melatonin in patients with low anterior resection syndrome (MELLARS): a study protocol for a randomised, placebo-controlled, crossover trial.

INTRODUCTION: After rectal cancer surgery, a majority of patients suffer from sequelae known as low anterior resection syndrome (LARS). It is a collection of symptoms consisting of flatus and/or stool incontinence, evacuation frequency, re-evacuation and urgency. The circadian hormone, melatonin, has shown to possess anti-inflammatory properties, and in high doses, it reduces bowel movements. The aim of the study is to investigate if locally administered melatonin has an alleviating effect on LARS. Secondarily, the effect of melatonin on bowel movements, other patient-reported symptoms, quality of life, depression, anxiety, sleep disturbances, motilin levels and rectal mucosa histology will be examined. METHODS AND ANALYSIS: This is a randomised, placebo-controlled, double-blinded, two-period crossover trial. The participants are randomised to 28 days of 25 mg melatonin administered rectally via an enema daily (or placebo) followed by a 28-day washout and then 28 days of placebo (or melatonin). Three participants will be included in an internal feasibility test. They will receive 25 mg of melatonin daily for 28 days. Data from these participants will be used to assess the feasibility of the rectally administered melatonin and to analyse the course of recruitment and outcome measurements. Afterwards, 18 participants will be included in the crossover trial. The severity of the LARS symptoms will be evaluated using the LARS Score on the first and last day of each treatment period. ETHICS AND DISSEMINATION: The Regional Ethics Committee, the Danish Medicines Agency and the Data and Development Support in Region Zealand approved this study. The study will be performed according to the Helsinki II declaration. Written informed consent will be obtained from all participants. The results of the study will be submitted to peer-reviewed journals for publication and presented at congresses. TRIAL REGISTRATION NUMBERS: EudraCT Registry (2020-004442-11) and ClinicalTrial.gov Registry (NCT05042700).

Sacral neuromodulation for low anterior resection syndrome: current status-a systematic review and meta-analysis.

INTRODUCTION: It is estimated that approximately 70% of patients with rectal cancer who undergo surgery will suffer from Low Anterior Resection Syndrome (LARS). In the last decades, sacral neuromodulation (SNM) has been widely used in urinary dysfunction and in faecal incontinence refractory to medical treatment. Its application in LARS has been investigated and has shown promising results. The paper's aim is to present a systematic review and meta-analysis of the available literature and evaluate the therapeutic success of SNM in patients with LARS. METHODS: A systematic search was performed in international health-related databases: Cochrane Library, EMBASE, PubMed and SciELO. No restrictions on year of publication or language were applied. Retrieved articles were screened and selected according to set inclusion criteria. Data items were collected and processed for each included article and a meta-analysis was done according to the PRISMA guidelines. The primary outcome was the number of successful definitive SNM implants. Further outcomes included changes in bowel habits, incontinence scores, quality of life scores, anorectal manometry data and complications. RESULTS: A total of 18 studies were included, with 164 patients being submitted to percutaneous nerve evaluation (PNE) with 91% responding successfully. During follow-up of therapeutic SNM some devices were explanted. The final clinical success rate was 77% after permanent implant. Other outcomes, such as the frequency of incontinent episodes, faecal incontinence scores, quality of life scores were overall improved after SNM. The meta-analysis showed a decrease in 10.11 incontinent episodes/week; a decrease of 9.86 points in the Wexner score and an increase in quality of life of 1.56 (pooled estimate). Changes in anorectal manometry were inconsistent. Local infection was the most common post-operative complication, followed by pain, mechanical issues, loss of efficacy and haematoma. DISCUSSION/CONCLUSION: This is the largest systematic review and meta-analysis concerning the use of SNM in LARS patients. The findings support the available evidence that sacral neuromodulation can be effective in the treatment of LARS, with significant improvement in total incontinent episodes and patients´ quality of life.

Pathway Of Low Anterior Resection syndrome relief after Surgery (POLARiS) feasibility trial protocol: a multicentre, feasibility cohort study with embedded randomised control trial to compare sacral neuromodulation and transanal irrigation to optimised conservative management in the management of major low anterior resection syndrome following rectal cancer treatment.

INTRODUCTION: Rectal cancer is common with a 60% 5-year survival rate. Treatment usually involves surgery with or without neoadjuvant chemoradiotherapy or adjuvant chemotherapy. Sphincter saving curative treatment can result in debilitating changes to bowel function known as low anterior resection syndrome (LARS). There are currently no clear guidelines on the management of LARS with only limited evidence for different treatment modalities. METHODS AND ANALYSIS: Patients who have undergone an anterior resection for rectal cancer in the last 10 years will be approached for the study. The feasibility trial will take place in four centres with a 9-month recruitment window and 12 months follow-up period. The primary objective is to assess the feasibility of recruitment to the POLARiS trial which will be achieved through assessment of recruitment, retainment and follow-up rates as well as the prevalence of major LARS.Feasibility outcomes will be analysed descriptively through the estimation of proportions with confidence intervals. Longitudinal patient reported outcome measures will be analysed according to scoring manuals and presented descriptively with reporting graphically over time. ETHICS AND DISSEMINATION: Ethical approval has been granted by Wales REC1; Reference 22/WA/0025. The feasibility study is in the process of set up. The results of the feasibility trial will feed into the design of an expanded, international trial. TRIAL REGISTRATION NUMBER: CT05319054.

The Role of Percutaneous Tibial Nerve Stimulation (PTNS) in Low Anterior Resection Syndrome (LARS): A Systematic Review and Meta-analysis.

PURPOSE: The aim of the present study was to evaluate the pooled efficacy of percutaneous tibial nerve stimulation (PTNS) in patients with low anterior resection syndrome (LARS). MATERIAL AND METHODS: This study was based on the Cochrane Handbook for Systematic Reviews of Interventions and the PRISMA guidelines. The primary endpoint was the pooled effect size of PTNS in LARS score (LARSS). Secondary endpoints included incontinence (Fecal Incontinence Score-FIC, Obstructive Defecation Syndrome-ODS), sexual functionality and quality of life (QoL) questionnaires, and manometric evaluations. Continuous outcomes were reported as weighted mean difference (WMD), with the corresponding 95% confidence interval (95% CI). Quality evaluation was performed via the National Institutes of Health (NIH) quality assessment tool. RESULTS: Overall, 5 studies were included. PTNS resulted to reduced LARSS values (WMD: - 5.68, 95%CI: - 7.73, - 3.63, p < 0.001). A similar effect was noted in St Mark's FIC (p < 0.001) and ODS (p = 0.02) score. An improvement in several QoL scales was found. There was no effect in sexual functionality and manometric measurements. Compared to sham, PTNS significantly improved LARSS. CONCLUSIONS: The application of PTNS in patients with LARS results in an improvement in multiple clinical parameters, including defecation functionality and quality of life. Due to several study limitations, further high quality RCTs are required to delineate the exact efficacy of PTNS.