Percutaneous tibial nerve stimulation in patients with severe low anterior resection syndrome: randomized clinical trial.

BACKGROUND: Treatment of low anterior resection syndrome (LARS) is challenging. Percutaneous tibial nerve stimulation (PTNS) can improve select bowel disorders. An RCT was conducted to assess the efficacy of PTNS compared with sham stimulation in patients with severe LARS. METHOD: This was a multicentre, double-blind RCT. Patients with major LARS score were allocated to receive PTNS or sham therapy (needle placement simulation without nerve stimulation). The study included 16 sessions of 30 min once a week for 12 consecutive weeks, followed by four additional sessions once a fortnight for the following 4 weeks. The primary endpoint was efficacy of PTNS defined by the LARS score 12 months after treatment. Secondary endpoints included faecal incontinence, quality of life (QoL), and sexual function. RESULTS: Between September 2016 and July 2018, 46 eligible patients were assigned randomly in a 1 : 1 ratio to PTNS or sham therapy. Baseline characteristics were similar. LARS scores were reduced in both groups, but only patients who received PTNS maintained the effect in the long term (mean(s.d.) score 36.4(3.9) at baseline versus 30.7(11.5) at 12 months; P = 0.018; effect size -5.4, 95 per cent c.i. -9.8 to -1.0), with a mean reduction of 15.7 per cent at 12-month follow-up. The faecal incontinence score was improved after 12 months in the PTNS group (mean(s.d.) score 15.4(5.2) at baseline versus 12.5(6.4) at 12 months; P = 0.018). No major changes in QoL and sexual function were observed in either group. There was no therapy-associated morbidity. Three patients discontinued the study, but none owing to study-related issues. CONCLUSION: PTNS has positive effects in some patients with major LARS, especially in those with faecal incontinence. Registration number: NCT02517853 (http://www.clinicaltrials.gov).

Preoperative oral antibiotic prophylaxis reduces Pseudomonas aeruginosa surgical site infections after elective colorectal surgery: a multicenter prospective cohort study.

BACKGROUND: Healthcare-associated infections caused by Pseudomonas aeruginosa are associated with poor outcomes. However, the role of P. aeruginosa in surgical site infections after colorectal surgery has not been evaluated. The aim of this study was to determine the predictive factors and outcomes of surgical site infections caused by P. aeruginosa after colorectal surgery, with special emphasis on the role of preoperative oral antibiotic prophylaxis. METHODS: We conducted an observational, multicenter, prospective cohort study of all patients undergoing elective colorectal surgery at 10 Spanish hospitals (2011-2014). A logistic regression model was used to identify predictive factors for P. aeruginosa surgical site infections. RESULTS: Out of 3701 patients, 669 (18.1%) developed surgical site infections, and 62 (9.3%) of these were due to P. aeruginosa. The following factors were found to differentiate between P. aeruginosa surgical site infections and those caused by other microorganisms: American Society of Anesthesiologists' score III-IV (67.7% vs 45.5%, p = 0.001, odds ratio (OR) 2.5, 95% confidence interval (95% CI) 1.44-4.39), National Nosocomial Infections Surveillance risk index 1-2 (74.2% vs 44.2%, p < 0.001, OR 3.6, 95% CI 2.01-6.56), duration of surgery ≥75thpercentile (61.3% vs 41.4%, p = 0.003, OR 2.2, 95% CI 1.31-3.83) and oral antibiotic prophylaxis (17.7% vs 33.6%, p = 0.01, OR 0.4, 95% CI 0.21-0.83). Patients with P. aeruginosa surgical site infections were administered antibiotic treatment for a longer duration (median 17 days [interquartile range (IQR) 10-24] vs 13d [IQR 8-20], p = 0.015, OR 1.1, 95% CI 1.00-1.12), had a higher treatment failure rate (30.6% vs 20.8%, p = 0.07, OR 1.7, 95% CI 0.96-2.99), and longer hospitalization (median 22 days [IQR 15-42] vs 19d [IQR 12-28], p = 0.02, OR 1.1, 95% CI 1.00-1.17) than those with surgical site infections due to other microorganisms. Independent predictive factors associated with P. aeruginosa surgical site infections were the National Nosocomial Infections Surveillance risk index 1-2 (OR 2.3, 95% CI 1.03-5.40) and the use of oral antibiotic prophylaxis (OR 0.4, 95% CI 0.23-0.90). CONCLUSIONS: We observed that surgical site infections due to P. aeruginosa are associated with a higher National Nosocomial Infections Surveillance risk index, poor outcomes, and lack of preoperative oral antibiotic prophylaxis. These findings can aid in establishing specific preventive measures and appropriate empirical antibiotic treatment.

Multistate modelling to estimate excess length of stay and risk of death associated with organ/space infection after elective colorectal surgery.

BACKGROUND: Accounting for time-dependency and competing events are strongly recommended to estimate excess length of stay (LOS) and risk of death associated with healthcare-associated infections. AIM: To assess the effect of organ/space (OS) surgical site infection (SSI) on excess LOS and in-hospital mortality in patients undergoing elective colorectal surgery (ECS). METHODS: A multicentre prospective adult cohort undergoing ECS, January 2012 to December 2014, at 10 Spanish hospitals was used. SSI was considered the time-varying exposure and defined as incisional (superficial and deep) or OS. Discharge alive and death were the study endpoints. The mean excess LOS was estimated using a multistate model which provided a weighted average based on the states patients passed through. Multivariate Cox regression models were used to assess the effect of OS-SSI on risk of discharge alive or in-hospital mortality. FINDINGS: Of 2778 patients, 343 (12.3%) developed SSI: 194 (7%) OS-SSI and 149 (5.3%) incisional SSI. Compared to incisional SSI or no infection, OS-SSI prolonged LOS by 4.2 days (95% confidence interval (CI): 4.1-4.3) and 9 days (8.9-9.1), respectively, reduced the risk of discharge alive (adjusted hazard ratio (aHR): 0.36 (95% CI: 0.28-0.47) and aHR: 0.17 (0.14-0.21), respectively), and increased the risk of in-hospital mortality (aHR: 8.02 (1.03-62.9) and aHR: 10.7 (3.7-30.9), respectively). CONCLUSION: OS-SSI substantially extended LOS and increased risk of death in patients undergoing ECS. These results reinforce OS-SSI as the SSI with the highest health burden in ECS.

Predictive factors for early- and late-onset surgical site infections in patients undergoing elective colorectal surgery. A multicentre, prospective, cohort study.

BACKGROUND: Surgical site infections (SSIs) are the leading cause of healthcare-associated infections in acute care hospitals in Europe. However, the risk factors for the development of early-onset (EO) and late-onset (LO) SSI have not been elucidated. AIM: This study investigated the predictive factors for EO-SSI and LO-SSI in a large cohort of patients undergoing colorectal surgery. METHODS: We prospectively followed-up adult patients undergoing elective colorectal surgery in 10 hospitals (2011-2014). Patients were divided into three groups: EO-SSI, LO-SSI, or no infection (no-SSI). The cut-off defining EO-SSI and LO-SSI was seven days (median time to SSI development). Different predictive factors for EO-SSI and LO-SSI were analysed, comparing each group with the no-SSI patients. FINDINGS: Of 3701 patients, 320 (8.6%) and 349 (9.4%) developed EO-SSI and LO-SSI, respectively. The rest had no-SSI. Patients with EO-SSI were mostly males, had colon surgery and developed organ-space SSI whereas LO-SSI patients frequently received chemotherapy or radiotherapy and had incisional SSI. Male sex (odds ratio (OR): 1.92; P < 0.001), American Society of Anesthesiologists' physical status >2 (OR: 1.51; P = 0.01), administration of mechanical bowel preparation (OR: 0.7; P = 0.03) and stoma creation (OR: 1.95; P < 0.001) predicted EO-SSI whereas rectal surgery (OR: 1.43; P = 0.03), prolonged surgery (OR: 1.4; P = 0.03) and previous chemotherapy (OR: 1.8; P = 0.03) predicted LO-SSI. CONCLUSION: We found distinctive predictive factors for the development of SSI before and after seven days following elective colorectal surgery. These factors could help establish specific preventive measures in each group.

Update on advances and controversy in rectal cancer treatment.

Changes in the multidisciplinary treatment of rectal cancer have been recently proposed. We performed a comprehensive review of the current data on neoadjuvant and adjuvant treatment of rectal cancer, focussing on chemoradiotherapy treatment and timing of surgery. Six components were proposed as the framework for the treatment of rectal cancer: neoadjuvant therapy and changing patterns in patient selection, long- or short-course radiotherapy, adverse effects of radiotherapy, timing of surgery, non-operative management of rectal cancer and postoperative adjuvant therapy. Lack of a consistent difference in terms of local recurrence has been observed between short-course radiotherapy and long-course chemoradiotherapy. Indications for preoperative radiotherapy have been reconsidered in the last years. An interval of 10-11 weeks seemed to be the optimal timing, with no impact on patient safety. Since assessment criteria of clinical complete response are not well defined, and the basis for non-operative management of rectal cancer is still not clear, further investigations are required. There is controversy about standard treatments for patients with locally advanced rectal cancer that are being analyzed by ongoing studies. Tailored treatments could avoid over-treatment for a large number of patients without any impairment of the oncologic results.

Risk factors for surgical site infection after elective resection for rectal cancer. A multivariate analysis on 2131 patients.

AIM: Surgical site infection (SSI) is the most common cause of morbidity after colorectal surgery. The aim of this study was to analyze risk factors for SSI in patients who had undergone surgery for rectal cancer. METHOD: A multicentre observational study was carried out on 2131 patients operated on for rectal cancer between May 2006 and May 2009. Twenty-nine centres were involved. SSI included wound infection and organ space infection within 30 days after the operation. Univariate and multivariate analyses were carried out to study possible risk factors for SSI. RESULTS: Wound infection and organ space infection were diagnosed in 8.9% and 10%, respectively, of patients. The anastomotic leakage rate was 8%. Multivariate analysis showed that wound infection was related to tumour stage, a converted laparoscopic procedure and open surgery. Organ space infection was related to Stage IV tumour, a tumour < 11 cm from the anal verge, low anterior resection and Hartmann's procedure. CONCLUSION: Rectal surgery for malignant disease is associated with a considerable rate of SSI. Wound infection and organ space infection are related to different factors and therefore should be evaluated separately.

Differences between proximal and distal obstructing colonic cancer after curative surgery.

AIM: To study any possible differences in morbidity, mortality and overall survival rate after curative surgery for obstructive colon cancer according to tumour location. METHOD: From January 1994 to December 2006, patients with colonic cancer presenting as obstruction were analysed. The two groups were defined as proximal and distal according to the tumour location with respect to the splenic flexure. In relation to the surgeon specialization, patients were operated on by a colorectal surgeon and by a general surgeon. Postoperative morbidity and mortality and cancer-related survival at 3 years were analysed. RESULTS: Of the 377 patients included in the study, there were 173 patients (45.9%) in the proximal group and 204 patients (54.1%) in the distal group. The global morbidity was 54.9% without differences in postoperative morbidity except for anastomotic leakage, which was higher in the proximal group (P < 0.014). No differences in postoperative mortality were observed. After patients were stratified by the tumour node metastasis system, the differences between the groups, with respect to 3-year overall survival, cancer-related survival and probability of being free from recurrence, did not reach statistical significance. The overall survival after radical surgery for colonic obstruction was 57.6%. CONCLUSION: Mortality and morbidity after emergency surgery for obstructing colon cancer are high. Specialization in colorectal surgery influences postoperative results in terms of lower anastomotic dehiscence rate after emergency proximal colon resection. After radical surgery, tumour location does not appear to influence the prognosis of obstructive colon cancer.

Comparative study to determine the need for intraoperative colonic irrigation for primary anastomosis in left-sided colonic emergencies.

OBJECTIVE: To compare the outcome of resection and primary anastomoses in patients undergoing emergency surgery of the left colon with and without intraoperative colonic irrigation. METHOD: From January 2004 to December 2006, 102 consecutive patients with acute occlusion or perforation of the left colon were operated on an emergency basis in two Coloproctology units. According to the sample size calculation, 61 patients from one unit underwent surgery with intraoperative colonic irrigation, whereas 41 patients from the second unit underwent surgery without intraoperative colonic irrigation. The endpoints were mortality and morbidity. RESULTS: Thirty (49.2%) patients with intraoperative colonic irrigation and 8 (19.5%) without colonic irrigation developed one or more complications postoperatively (odds ratio 4.0, 95% CI 1.6-10.0, P = 0.002). An increased number of wound infections was seen in the group managed with colonic irrigation 15 vs 3 (P = 0.034). The postoperative mortality rate and the occurrence of dehiscence of the anastomoses were similar in both study groups. CONCLUSION: The present findings indicate that resection and primary anastomosis in patients undergoing emergency surgery of the left colon can be safely performed without intraoperative colonic irrigation.

Comparative study of left colonic Peritonitis Severity Score and Mannheim Peritonitis Index.

BACKGROUND: Prognostic evaluation of patients with left colonic perforation is useful in predicting mortality. The aims of this prospective study were to determine the prognostic value of the left colonic Peritonitis Severity Score (PSS) and to compare it with the Mannheim Peritonitis Index (MPI). METHODS: One-hundred and fifty-six patients underwent emergency operation for distal colonic peritonitis. The PSS and MPI were calculated for each patient. The Spearman rank correlation coefficient was used to measure the association between the two scores. The predictive power of the two scoring systems and their differences were studied using the area under the receiver-operator characteristic (ROC) curve. RESULTS: Forty-one patients died (26.3 per cent). The relationship between scores and mortality was statistically significant for each scoring system (P < 0.001). The Spearman rank correlation coefficient for the correlation between the MPI and PSS was 0.55 (P < 0.001). There was no difference between areas under the ROC curves for the two systems. CONCLUSION: The PSS and MPI are both well validated scoring systems for left colonic peritonitis. Their routine use might allow stratification of patients according to mortality risk.

Acute colonic diverticulitis in patients under 50 years of age.

BACKGROUND: There is ongoing controversy concerning the virulence and management of diverticulitis in young patients. This study reports on the management of acute diverticulitis with reference to the virulence and outcome of the disease with respect to age. METHODS: Between January 1994 and June 1999, 327 patients were treated for acute left colonic diverticulitis. Patients were divided in two groups: those aged 50 years or less (group 1, 72 patients) and those older than 50 years (group 2, 255 patients). The diagnosis was confirmed histologically or radiologically in all patients. RESULTS: There were differences in gender distribution related to age (P < 0.001). During the first hospital stay, 226 patients (69.1 per cent) had successful conservative treatment, 78 (23.9 per cent) needed emergency surgery and 23 (7.0 per cent) had a semielective operation (P = 0.47). The recurrence rate was 25.5 per cent in group 1 and 22.3 per cent in group 2 (P = 0.93). The type of surgical procedure and grade of peritonitis in emergency patients were similar in the two groups. Overall the mortality rate in patients who underwent an operation was 16.3 per cent. The mortality rate was zero in group 1 and 2.2 per cent in group 2 after elective or semielective operation (P = 1.0), and zero in group 1 and 34.9 per cent in group 2 after emergency operation (P < 0.001). CONCLUSION: Diverticulitis in young patients does not have a particularly aggressive course and the risk of recurrence is similar to that of older patients.