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 ).

EAES, SAGES, and ESCP rapid guideline: bowel preparation for minimally invasive colorectal resection.

BACKGROUND: Variation exists in practice pertaining to bowel preparation before minimally invasive colorectal surgery. A survey of EAES members prioritized this topic to be addressed by a clinical practice guideline. OBJECTIVE: The aim of the study was to develop evidence-informed clinical practice recommendations on the use of bowel preparation before minimally invasive colorectal surgery, through evidence synthesis and a structured evidence-to-decision framework by an interdisciplinary panel of stakeholders. METHODS: This is a collaborative project of EAES, SAGES, and ESCP. We updated a previous systematic review and performed a network meta-analysis of interventions. We appraised the certainty of the evidence for each comparison, using the GRADE and CINeMA methods. A panel of general and colorectal surgeons, infectious diseases specialists, an anesthetist, and a patient representative discussed the evidence in the context of benefits and harms, the certainty of the evidence, acceptability, feasibility, equity, cost, and use of resources, moderated by a GIN-certified master guideline developer and chair. We developed the recommendations in a consensus meeting, followed by a modified Delphi survey. RESULTS: The panel suggests either oral antibiotics alone prior to minimally invasive right colon resection or mechanical bowel preparation (MBP) plus oral antibiotics; MBP plus oral antibiotics prior to minimally invasive left colon and sigmoid resection, and prior to minimally invasive right colon resection when there is an intention to perform intracorporeal anastomosis; and MBP plus oral antibiotics plus enema prior to minimally invasive rectal surgery (conditional recommendations); and recommends MBP plus oral antibiotics prior to minimally invasive colorectal surgery, when there is an intention to localize the lesion intraoperatively (strong recommendation). The full guideline with user-friendly decision aids is available in https://app.magicapp.org/#/guideline/LwvKej . CONCLUSION: This guideline provides recommendations on bowel preparation prior to minimally invasive colorectal surgery for different procedures, using highest methodological standards, through a structured framework informed by key stakeholders. Guideline registration number PREPARE-2023CN045.

Sacral nerve modulation for patients with fecal incontinence: long-term outcome and effects on sexual function.

Sacral nerve modulation has become an established treatment for fecal and urinary incontinence, and sexual disorders. The objective of this study was to evaluate the long-term outcome of sacral neuromodulation in patients with fecal or combined fecal and urinary incontinence (double incontinence), assessing its safety, efficacy, and impact on quality of life and sexual function. This was a multicentric, retrospective, cohort study including patients with fecal or double incontinence who received sacral neuromodulation at seven European centers between 2007 and 2017 and completed a 5-year follow-up. The main outcome measures included improvements of incontinence symptoms and quality of life compared with baseline, evaluated using validated tools and questionnaires at 1-, 6-, 12-, 36- and 60-month follow-up. 108 (102 women, mean age 62.4 ± 13.4 years) patients were recruited, of whom 88 (81.4%) underwent definitive implantation of the pacemaker. Patients' baseline median Cleveland Clinic Incontinence Score was 15 (10-18); it decreased to 2 (1-4) and 1 (1-2) at the 12- and 36-month follow-up (p < 0.0001), remaining stable at the 5-year follow-up. Fecal incontinence quality of life score improved significantly. All patients with sexual dysfunction (n = 48) at baseline reported symptom resolution at the 5-year follow-up. The study was limited by the retrospective design and the relatively small patient sample. Sacral nerve modulation is an effective treatment for fecal and double incontinence, achieving satisfactory long-term success rates, with resolution of concomitant sexual dysfunction.

BNT162b2 mRNA COVID-19 vaccine is safe in a setting of patients on biologic therapy with inflammatory bowel diseases: a monocentric real-life study.

OBJECTIVES: Patients with inflammatory bowel disease were excluded from trials that led to the approval of anti-COVID-19 vaccines and are worthy of real-life studies providing information on the safety of these vaccines in this clinical setting. METHODS: A prospective observational study was performed to estimate BNT162b2 mRNA COVID-19 Vaccine local and systemic adverse events (AEs) incidence related to administration in patients with inflammatory bowel disease through a questionnaire administered at the first, second, and third doses. Disease activity by Mayo Partial Score and Harvey-Bradshaw Index was also evaluated. RESULTS: Eighty patients with a median age of 47.5 years were initially enrolled. The local AEs rate was 26.25%, 58.75%, and 28.37% at the first, second, and third doses of the vaccine, respectively. In contrast, the systemic AEs rate was 52.2%, 48.75%, and 43.24%. Clinic-demographic predictor variables for AEs were not identified. Vaccination did not affect disease activity and no statistically significant difference in disease activity index scores was observed between the three doses. No serious adverse events were observed. CONCLUSION: This vaccine was safe in a population of patients with inflammatory bowel disease and, therefore, could be safely administered in this clinical setting.

Preoperative oral antibiotics and surgical-site infections in colon surgery (ORALEV): a multicentre, single-blind, pragmatic, randomised controlled trial.

BACKGROUND: Previous studies have found that mechanical bowel preparation with oral antibiotics can reduce the incidence of surgical-site infections, but no randomised controlled trial has assessed oral antibiotics alone without mechanical bowel preparation. The aim of this study was to determine whether prophylaxis with oral antibiotics the day before elective colon surgery affects the incidence of postoperative surgical-site infections. METHODS: In this multicentre, pragmatic, randomised controlled trial (ORALEV), patients undergoing colon surgery were recruited from five major hospitals in Spain and 47 colorectal surgeons at these hospitals participated. Patients were eligible for inclusion if they were diagnosed with neoplasia or diverticular disease and if a partial colon resection or total colectomy was indicated. Participants were randomly assigned (1:1) using online randomisation tables to either administration of oral antibiotics the day before surgery (experimental group) or no administration of oral antibiotics before surgery (control group). For the experimental group, ciprofloxacin 750 mg was given every 12 h (two doses at 1200 h and 0000 h) and metronidazole 250 mg every 8 h (three doses at 1200 h, 1800 h, and 0000 h) the day before surgery. All patients were given intravenous cefuroxime 1·5 g and metronidazole 1 g at the time of anaesthetic induction. The primary outcome was incidence of surgical-site infections. Patients were followed up for 1 month after surgery and all postsurgical complications were registered. This study was registered with EudraCT, 2014-002345-21, and ClinicalTrials.gov, NCT02505581, and is closed to accrual. FINDINGS: Between May 2, 2015, and April 15, 2017, we assessed 582 patients for eligibility, of whom 565 were eligible and randomly assigned to receive either no oral antibiotics (n=282) or oral antibiotics (n=282) before surgery. 13 participants in the control group and 16 in the experimental group were subsequently excluded; 269 participants in the control group and 267 in the experimental group received their assigned intervention. The incidence of surgical-site infections in the control group (30 [11%] of 269) was significantly higher than in the experimental group (13 [5%] of 267; χ2 test p=0·013). Oral antibiotics were associated with a significant reduction in the risk of surgical-site infections compared with no oral antibiotics (odds ratio 0·41, 95% CI 0·20-0·80; p=0·008). More complications (including surgical-site infections) were observed in the control group than in the experimental group (76 [28%] vs 51 [19%]; p=0·017), although there was no difference in severity as assessed by Clavien-Dindo score. No differences were noted between groups in terms of local complications, surgical complications, or medical complications that were not related to septic complications. INTERPRETATION: The administration of oral antibiotics as prophylaxis the day before colon surgery significantly reduces the incidence of surgical-site infections without mechanical bowel preparation and should be routinely adopted before elective colon surgery. FUNDING: Fundación Asociación Española de Coloproctología.

A systematic review and network meta-analysis comparing treatments for faecal incontinence.

BACKGROUND: Although numerous treatments exist for fecal incontinence (FI), no consensus exists on the best treatment strategy. The aim was to review the literature and to compare the clinical outcomes and effectiveness of treatments available for FI. MATERIALS AND METHOD: A systematic literature review was performed, from inception to May 2018, of the following databases: MEDLINE, EMBASE, Science Citation Index Expanded, Cochrane Library. The search terms used were "faecal incontinence" and "treatment". Only randomized controlled trials (RCTs) comparing treatments for FI were considered. A Bayesian network meta-analysis was performed using the Markov chain Monte Carlo method. RESULT: Forty-seven RCTs were included comparing 37 treatments and reporting on 3748 participants. No treatment ranked best or worst with high probability for any outcome of interest. No significant difference was identified between treatments for frequency of FI per week, or in changing the resting pressure, maximum resting pressure, squeeze pressure, and maximum squeeze pressure. Radiofrequency resulted in more adverse events compared to placebo. Sacral nerve stimulation (SNS) and zinc-aluminium improved the fecal incontinence quality of life questionnaire (FIQL) lifestyle, coping, and embarrassment domains compared to placebo. Transcutaneous posterior tibial nerve stimulation (TPTNS) improved the FIQL embarrassment domain compared to placebo. Autologous myoblasts and zinc-aluminium improved the FIQL depression domain compared to placebo. SNS, artificial bowel sphincter (ABS), and zinc-aluminium significantly improved incontinence scores compared to placebo. Injection of non-animal stabilized hyaluronic acid/dextranomer (NASHA/Dx) resulted in more patients with ≥50% reduction in FI episodes compared to placebo. CONCLUSION: SNS, ABS, TPTNS, NASHA/Dx, zinc-aluminium, and autologous myoblasts resulted in isolated improvements in specific outcomes of interest. No difference was identified in incontinence episodes, no treatment ranked best persistently or persistently improved outcomes, and many included treatments did not significantly benefit patients compared to placebo. Large multicentre RCTs with long-term follow-up and standardized inclusion criteria and outcome measures are needed.

European Crohn's and Colitis Organisation Topical Review on Complementary Medicine and Psychotherapy in Inflammatory Bowel Disease.

Patients with inflammatory bowel disease [IBD] increasingly use alternative and complementary therapies, for which appropriate evidence is often lacking. It is estimated that up to half of all patients with IBD use various forms of complementary and alternative medicine during some point in their disease course. Considering the frequent use of such therapies, it is crucial that physicians and patients are informed about their efficacy and safety in order to provide guidance and evidence-based advice. Additionally, increasing evidence suggests that some psychotherapies and mind-body interventions may be beneficial in the management of IBD, but their best use remains a matter of research. Herein, we provide a comprehensive review of some of the most commonly used complementary, alternative and psychotherapy interventions in IBD.

Comparison of Western and Asian Guidelines Concerning the Management of Colon Cancer.

BACKGROUND: Guidelines are important to standardize treatments and optimize outcomes. Several societies have published authoritative guidelines for patients with colon cancer, and a certain degree of variation can be predicted. OBJECTIVE: This study aims to compare Western and Asian guidelines for the management of colon cancer. DATA SOURCES: A literature review was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for studies published between 2010 and 2017 by the online resources from the official Web sites of the societies/panels. Sources included guidelines by European Society of Medical Oncology, the Japanese Society for Cancer of the Colon and Rectum, and the National Comprehensive Cancer Network. STUDY SELECTION: Only full-text studies and the latest guidelines dealing with colon cancer were included. Studies and guidelines were separately assessed by 2 authors, who independently identified discrepancies and areas for further research. These were discussed and agreed with by all the authors. MAIN OUTCOME MEASURES: The recommendations of the guidelines of each society were compared, seeking discrepancies and potential areas for improvement. RESULTS: Endoscopic techniques for the management of early colon cancer are discussed in detail in the Asian guidelines. Asian guidelines advocate extended (D3) lymphadenectomy on a routine basis in T3/T4 and in selected T2 patients, whereas such an approach is still under investigation in Western countries. Only US guidelines describe neoadjuvant chemotherapy and radiotherapy. All the guidelines recommend adjuvant treatment in selected stage II patients, but agreement exists that this is performed without solid evidence, because better outcomes are hypothesized based on studies including stage III or stage II/III patients. The role of cytoreductive surgery with intra-abdominal chemotherapy is dubious, and European guidelines only recommend it in the setting of trials. Asian guidelines endorse an aggressive surgical approach to peritoneal disease. Only US guidelines include a patient advocate in the drafting panel. LIMITATIONS: Bias may have arisen from country-specific socioeconomic and cultural issues, and from the latest available updates. CONCLUSIONS: Surgical approaches to colon cancer differ significantly among Western and Asian guidelines, reflecting different concepts of treatment. The role of adjuvant treatment in node-negative disease and quality-of-life assessment need further research.

Discrepancies between NCCN and ESMO guidelines in the management of anal cancer: a qualitative review.

There is an ever-growing need, with the ongoing developments in research and the progress towards patient centered care, to delineate standardized protocols of management of anal cancer. However, guidelines from different societies show some degree of disagreement. This is a systematic review of the literature to identify similarities and discrepancies between the guidelines for the management of anal cancer drafted by the European Society for Medical Oncology (ESMO) and by the National Comprehensive Cancer Network (NCCN). We found essentially similar management for investigation, diagnosis, chemotherapy regimens, and radiotherapy doses in both ESMO and NCCN recommendations in the management of anal cancer. There were few differences, which included the levels of evidence and grades of recommendations, the delineation of radiotherapy fields, and the treatment of the elderly and personalized medicine based on genetics. The follow-up regime is also marginally different in the first 2 years. Even if the observed differences may be justified by a different implementation of evidence-based medicine among different countries for particular management modalities of anal cancer, we identified the grey areas which need further study. In addition, these facets should be assessed more carefully when planning future guidelines.