The impact of anastomotic leak on long-term oncological outcomes after low anterior resection for mid-low rectal cancer: extended follow-up of a randomised controlled trial.

PURPOSE: The impact of anastomotic leaks (AL) on oncological outcomes after low anterior resection for mid-low rectal cancer is still debated. The aim of this study was to evaluate overall survival (OS), disease-free survival (DFS), and local and distant recurrence in patients with AL following low anterior resection. METHODS: This is an extension of a multicentre RCT (NCT01110798). Kaplan-Meier method and the log-rank test were used to estimate and compare the 3-, 5-, and 10-year OS and DFS, and local and distant recurrence in patients with and without AL. Predictors of OS and DFS were evaluated using the Cox regression analysis as secondary aim. RESULTS: Follow-up was available for 311 patients. Of them, 252 (81.0%) underwent neoadjuvant chemoradiotherapy and 138 (44.3%) adjuvant therapy. AL occurred in 63 (20.3%) patients. At a mean follow-up of 69.5 ± 31.9 months, 23 (7.4%) patients experienced local recurrence and 49 (15.8%) distant recurrence. The 3-, 5-, and 10-year OS and DFS were 89.2%, 85.3%, and 70.2%; and 80.7%, 75.1%, and 63.5% in patients with AL, and 88.9%, 79.8% and 72.3%; and 83.7, 74.2 and 62.8%, respectively in patients without (p = 0.89 and p = 0.84, respectively). At multivariable analysis, AL was not an independent predictor of OS (HR 0.65, 95%CI 0.34-1.28) and DFS (HR 0.70, 95%CI 0.39-1.25), whereas positive circumferential resection margins and pathological stage impaired both. CONCLUSIONS: In the context of modern multimodal rectal cancer treatment, AL does not affect long-term OS, DFS, and local and distant recurrence in patients with mid-low rectal cancer.

Sacral nerve stimulation for fecal incontinence related to external sphincter atrophy.

BACKGROUND: Atrophy of the external anal sphincter, a pathologic muscle volume anomaly associated with fecal incontinence, has been shown to be a negative predictor of the outcome of surgery for defects of the external anal sphincter. It is unclear whether external anal sphincter atrophy also affects the outcome of sacral nerve stimulation for fecal incontinence. OBJECTIVE: Our aim was to assess the effectiveness of sacral nerve stimulation in patients with fecal incontinence and external anal sphincter atrophy and to determine whether severity of atrophy and concomitant presence of a sphincter defect are negative predictors of outcome. DESIGN: This was a prospective observational study of treatment outcome. SETTING: The study was conducted from November 2004 through November 2010 at a regional hospital in Italy. PATIENTS: Consecutive patients with fecal incontinence and external anal sphincter atrophy were included. By means of MRI, patients were determined to have either moderate (<50%) or severe (≥ 50%) thinning of and/or replacement of sphincter muscle by fat. The concomitant presence of defects of the external anal sphincter was also detected by MRI. INTERVENTION: All patients underwent sacral nerve stimulation through a staged implantation procedure. MAIN OUTCOME MEASURES: The main outcome measures were improvement in the Cleveland Clinic Florida Fecal Incontinence Scale (Wexner score), number of episodes of incontinence per week, and the Fecal Incontinence Quality of Life Scale. RESULTS: A total of 28 patients underwent definitive implantation of the sacral nerve stimulation device. Wexner scores decreased from a median of 16 (range, 10-20) at baseline to 3 (range, 0-8) at 6-month follow-up (p < 0.001). Weekly incontinence episodes decreased from a mean (SD) of 14.7 (12.5) to 0.40 (0.82); p < 0.001. Improvement was significantly related to severity of fecal incontinence (r = 0.86; p < 0.001). Overall quality-of-life scores improved from a mean of 1.8 (0.6) to 3.8 (0.4);p < 0.001. Sacral nerve stimulation was effective in both moderate (n = 16) and severe (n = 12) atrophy and in patients with (n = 8) or without (n = 20) external anal sphincter defects. LIMITATIONS: The study was limited by its observational nature and relatively small sample size. CONCLUSIONS: Sacral nerve stimulation can be effective in restoring continence and improving quality of life in patients with fecal incontinence related to atrophy of the external anal sphincter, regardless of the severity of atrophy. Moreover, the presence of EAS atrophy does not influence the success of the outcome of SNS in patients with a sphincter defect. These findings are consistent with the hypothesis that the effects of SNS are not achieved solely by its action on the anal sphincter complex.

Is sacral nerve stimulation an effective treatment for chronic idiopathic anal pain?

BACKGROUND: Chronic idiopathic anal pain is a common, benign symptom, the etiology of which remains unclear. Traditional treatments are often ineffective. This study investigated the efficacy of sacral nerve stimulation in treating chronic idiopathic anal pain. METHODS: Twelve patients (10 women and 2 men; mean age, 61.0 +/- 10.3 years; range, 48-82 years) implanted with a permanent device for sacral nerve stimulation were followed in the Italian Group for Sacral Neuromodulation (GINS) Registry. All patients had frequent chronic anal or perianal pain; 75 percent had previously undergone pelvic surgery. Pharmacologic and rehabilitative therapy had yielded poor results. Changes from baseline to last follow-up examination were evaluated for scores on a visual analog pain scale (0-10) and the Short-Form 36 (SF-36) health status questionnaire. Manometric measurements recorded at last follow-up were compared with preimplantation values. RESULTS: In one patient, the permanent device was removed because of technical failure. After a mean follow-up of 15 (range, 3-80) months, visual analog pain scores had significantly improved (from 8.2 +/- 1.7 to 2.2 +/- 1.3, P < 0.001). SF-36 physical component scores increased from 26.27 +/- 5.65 to 38.95 +/- 9.08, P < 0.02). Scores on the mental component showed improvement, although not significant. Postimplantation changes in manometric functional data were not significant, but sensitivity thresholds showed a considerable decrease. CONCLUSIONS: Long-term follow-up data showing improvements in scores on the visual analog pain scale and quality of life questionnaire indicate that, before adopting more aggressive surgical procedures, SNS should be considered for patients with chronic idiopathic anal pain in whom pharmacologic and biofeedback treatments have failed to produce effective results.