Effectiveness, safety and cost-effectiveness of sacral neuromodulation for idiopathic slow-transit constipation: a systematic review.

AIM: Sacral neuromodulation (SNM) is a minimally invasive treatment option for functional constipation. Evidence regarding its effectiveness is contradictory, driven by heterogeneous study populations and designs. The aim of this study was to assess the effectiveness, safety and cost-effectiveness of SNM in children and adults with refractory idiopathic slow-transit constipation (STC). METHOD: OVID Medline, OVID Embase, Cochrane Library, the KSR Evidence Database, the NHS Economic Evaluation Database and the International HTA Database were searched up to 25 May 2023. For effectiveness outcomes, randomized controlled trials (RCTs) were selected. For safety outcomes, all study designs were selected. For cost-effectiveness outcomes, trial- and model-based economic evaluations were selected for review. Study selection, risk of bias and quality assessment, and data extraction were independently performed by two reviewers. For the intervention 'sacral neuromodulation' effectiveness outcomes included defaecation frequency and constipation severity. Safety and cost-effectiveness outcomes were, respectively, adverse events and incremental cost-effectiveness ratios. RESULTS: Of 1390 records reviewed, 67 studies were selected for full-text screening. For effectiveness, one cross-over and one parallel-group RCT was included, showing contradictory results. Eleven studies on safety were included (four RCTs, three prospective cohort studies and four retrospective cohort studies). Overall infection rates varied between 0% and 22%, whereas reoperation rates varied between 0% and 29%. One trial-based economic evaluation was included, which concluded that SNM was not cost-effective compared with personalized conservative treatment at a time horizon of 6 months. The review findings are limited by the small number of available studies and the heterogeneity in terms of study populations, definitions of refractory idiopathic STC and study designs. CONCLUSION: Evidence for the (cost-)effectiveness of SNM in children and adults with refractory idiopathic STC is inconclusive. Reoperation rates of up to 29% were reported.

The Artificial Bowel Sphincter in the Treatment of Fecal Incontinence, Long-term Complications.

BACKGROUND: Fecal incontinence is a common and debilitating condition, of which the prevalence increases with age. Several medical and minimally invasive treatment modalities are available. However, for patients with greater sphincter defects, these treatments are often not sufficient. For these patients, the artificial bowel sphincter could be an alternative to colostomy. The artificial bowel sphincter has proven to be effective in the short term. Less is known whether the benefits sustain over time. OBJECTIVE: The aim of this study was to assess the long-term outcome of the artificial bowel sphincter in patients with refractory fecal incontinence. DESIGN: A retrospective record review was conducted in conjunction with questionnaires. SETTING: This study was conducted in a tertiary hospital setting. MAIN OUTCOME MEASURES: The primary end point was any complication. The secondary end point was fecal loss. PATIENTS: The patients included were adults experiencing severe fecal incontinence treated with artificial bowel sphincter, operated on between 1997 and 2014. RESULTS: Sixty-three patients were included in this study. After a median follow-up of 57 months (range, 1-198), the device had been explanted in 31 patients (49.2%; 95% CI, 36.5-62.0). In total, 101 reoperations were conducted, ranging from 1 to 6 reoperations per patient. The main reasons for revision were device failure and infection. At 5 years follow-up, 80% of the cohort had experienced a complication requiring surgery. Twenty-two (35%) patients had restored continence. LIMITATIONS: This study was limited by its retrospective design and subjective secondary outcome. CONCLUSION: Patients with severe end-stage fecal incontinence can benefit from artificial bowel sphincter, but this requires a large number of reoperations, and at least 20% of patients will eventually have a colostomy. Therefore, careful patient selection and the involvement of patients in decision making regarding the potential benefits and limitations of this technique are paramount. See Video Abstract at http://links.lww.com/DCR/B242. EL ESFÍNTER INTESTINAL ARTIFICIAL EN EL TRATAMIENTO DE LA INCONTINENCIA FECAL, COMPLICACIONES A LARGO PLAZO: La incontinencia fecal es una condición común y debilitante, cuya prevalencia aumenta con la edad. Se encuentran disponibles varias modalidades de tratamiento médico y mínimamente invasivo. Sin embargo, para pacientes con defectos del esfínter mayores, estos tratamientos a menudo no son suficientes. Para estos pacientes, el esfínter intestinal artificial (ABS) podría ser una alternativa a la colostomía. El esfínter intestinal artificial demostró ser efectivo a corto plazo. Se sabe menos si los beneficios se mantienen a lo largo del tiempo.El objetivo de este estudio fue evaluar el resultado a largo plazo del esfínter intestinal artificial en pacientes con incontinencia fecal refractaria.Se realizó una revisión retrospectiva de los registros junto con los cuestionarios.Realizado en un entorno de hospital de tercel nivel.El punto final primario fue cualquier complicación, el punto final secundario fue la pérdida fecal.Los pacientes incluidos fueron adultos que padecían incontinencia fecal severa tratados con esfínter intestinal artificial, operados entre 1997 y 2014.Sesenta y tres pacientes fueron incluidos en este estudio. Después de una mediana de seguimiento de 57 meses (rango 1-198), el dispositivo había sido explantado en 31 pacientes (49.2%; 95CI 36.5-62.0). En total, se realizaron 101 reoperaciones, que oscilaron de una a seis reoperaciones por paciente. Las principales razones para la revisión fueron la falla del dispositivo y la infección. A los cinco años de seguimiento, el 80% de la cohorte había experimentado una complicación que requería cirugía. 22 pacientes habían recuperado la continencia (35%).Diseño retrospectivo y resultado secundario subjetivo.Los pacientes con incontinencia fecal grave en etapa terminal pueden beneficiarse del esfínter intestinal artificial, pero esto requiere una gran cantidad de reoperaciones y al menos el 20% de los pacientes eventualmente tendrán una colostomía. Por lo tanto, la selección cuidadosa del paciente y la participación de los pacientes en la toma de decisiones con respecto a los posibles beneficios y limitaciones de esta técnica es primordial. Consulte Video Resumen en http://links.lww.com/DCR/B242.

Sacral neuromodulation in children and adolescents with chronic constipation refractory to conservative treatment.

PURPOSE: Functional constipation in children and adolescents is a common and invalidating condition. In a minority of patients, symptoms persist despite optimal conservative therapy. The aim of this study was to evaluate whether the short-term effects of sacral neuromodulation (SNM) in children and adolescents with constipation are sustained over prolonged period of time. METHODS: Patients aged 10-20 years, with refractory constipation, fulfilling the Rome III criteria, were included in our study. If SNM test treatment showed >50 % improvement in defecation frequency, a permanent stimulator was implanted. Primary outcome measure was defecation frequency during 3 weeks. Secondary endpoints were abdominal pain and Wexner score. To assess sustainability of treatment effect, a survival analysis was performed. Cross-sectional quality of life was assessed using the EQ-5D VAS score. RESULTS: Thirty girls, mean age 16 (range 10-20), were included. The mean defecation frequency increased from 5.9 (SD 6.5) in 21 days at baseline to 17.4 (SD 11.6) after 3 weeks of test treatment (p < 0.001). During test treatment, abdominal pain and Wexner score decreased from 3.6 to 1.5 and 18.6 to 8.5 (p < 0.001), respectively. Improvement of symptoms sustained during a median follow-up of 22.1 months (12.2-36.8) in 42.9 % of patients. On a scale from 0 to 100, quality of life was 7 points lower than the norm score (mean 70 vs. 77). CONCLUSION: SNM is a therapeutic option for children with chronic constipation not responding to intensive oral and/or laxative therapy, providing benefits that appear to be sustained over prolonged period of time.

To drain or not to drain: a cumulative meta-analysis of the use of routine abdominal drains after pancreatic resection.

BACKGROUND: To warrant the adoption or rejection of health care interventions in daily practice, it is important to establish the point at which the available evidence is considered sufficiently conclusive. This process must avoid bias resulting from multiple testing and take account of heterogeneity across studies. The present paper addresses the issue of whether the available evidence may be considered sufficiently conclusive to continue or discontinue the current practice of postoperative abdominal drainage after pancreatic resection. METHODS: A systematic review was conducted of randomized and non-randomized studies comparing outcomes after routine intra-abdominal drainage with those after no drainage after pancreatic resection. Studies were retrieved from the PubMed, Cochrane Central Trial Register and EMBASE databases and meta-analysed cumulatively, adjusting for multiple testing and heterogeneity using the iterated logarithm method. RESULTS: Three reports, describing, respectively, one randomized and two non-randomized studies with a comparative design, met the inclusion criteria predefined for primary studies reporting on drain management and complications after pancreatic resection. These studies included 89, 179 and 226 patients, respectively. The absolute differences in rates of postoperative complications in these studies were -6.4%, -9.5% and -6.3%, respectively, in favour of the no-drain groups. The cumulative risk difference in major complications, adjusted for multiple testing and heterogeneity, was -7.8%, with a 95% confidence interval of -20.2% to 4.7% (P = 0.214). CONCLUSIONS: The routine use of abdominal drains after pancreatic resection may result in a higher risk for major complications, but the evidence is inconclusive.

A systematic review of outcomes in patients undergoing liver surgery in an enhanced recovery after surgery pathways.

OBJECTIVES: Enhanced recovery after surgery (ERAS) or fast-track protocols have been implemented in different fields of surgery to attenuate the surgical stress response and accelerate recovery. The objective of this study was to systematically review the literature on outcomes of ERAS protocols applied in liver surgery. METHODS: The MEDLINE, EMBASE, PubMed and Cochrane Library databases were searched for randomized controlled trials (RCTs), case-control studies and case series published between January 1966 and October 2011 comparing adult patients undergoing elective liver surgery in an ERAS programme with those treated in a conventional manner. The primary outcome measure was hospital length of stay (LoS). Secondary outcome measures were time to functional recovery, and complication, readmission and mortality rates. RESULTS: A total of 307 articles were found, six of which were included in the review. These comprised two RCTs, three case-control studies and one retrospective case series. Median LoS ranged from 4 days in an ERAS group to 11 days in a control group. Morbidity, mortality and readmission rates did not differ significantly between the groups. Only two studies assessed time to functional recovery. Functional recovery in these studies was reached 2 days before discharge. CONCLUSIONS: This systematic review suggests that ERAS protocols can be successfully implemented in liver surgery. Length of stay is reduced without compromising morbidity, mortality or readmission rates.