Ten-year Evaluation of a Large Retrospective Cohort Treated by Sacral Nerve Modulation for Fecal Incontinence: Results of a French Multicenter Study.

OBJECTIVE: The aim of this study was to assess the effectiveness of sacral nerve modulation (SNM) in a large cohort of patients implanted for at least 10 years, quantify adverse event rates, and identify predictive factors of long-term success. SUMMARY BACKGROUND DATA: Few studies have evaluated the long-term success of SNM. METHODS: Data collected prospectively from patients implanted for fecal incontinence (FI) in 7 French centers between January 1998 and December 2008 were retrospectively analyzed. Patient FI severity scores were assessed before and 10 years after implantation. The main evaluation criterion was the success of SNM defined by the continuation of the treatment without additional therapies. The secondary evaluation criteria were the rate of device revisions and explantations. Preoperative predictors of success at 10 years were sought. RESULTS: Of the 360 patients (27 males, mean age: 59 ± 12 years) implanted for FI, 162 (45%) had a favorable outcome 10 years post-implantation, 115 (31.9%) failed, and 83 (23.1%) were lost to follow-up. The favorable outcome derived from the time-to-event Kaplan-Meier curve at 10 years was 0.64 (95% CI 0.58-0.69). FI severity scores were significantly better 10 years post-implantation compared to preimplantation (7.4 ± 4.3 vs 14.0 ± 3.2; P < 0.0001). During the 10-year follow-up, 233 patients (64.7%) had a surgical revision and 94 (26.1%) were explanted. A history of surgery for FI and sex (male) were associated with an increased risk of an unfavorable outcome. CONCLUSIONS: Long-term efficacy was maintained in approximately half of the FI patients treated by SNM at least 10 years post-implantation.

End Colostomy With or Without Mesh to Prevent a Parastomal Hernia (GRECCAR 7): A Prospective, Randomized, Double Blinded, Multicentre Trial.

OBJECTIVE: To evaluate whether systematic mesh implantation upon primary colostomy creation was effective to prevent PSH. SUMMARY OF BACKGROUND DATA: Previous randomized trials on prevention of PSH by mesh placement have shown contradictory results. METHODS: This was a prospective, randomized controlled trial in 18 hospitals in France on patients aged ≥18 receiving a first colostomy for an indication other than infection. Participants were randomized by blocks of random size, stratified by center in a 1:1 ratio to colostomy with or without a synthetic, lightweight monofilament mesh. Patients and outcome assessors were blinded to patient group. The primary endpoint was clinically diagnosed PSH rate at 24 months of the intention-to-treat population. This trial was registered at ClinicalTrials.gov, number NCT01380860. RESULTS: From November 2012 to October 2016, 200 patients were enrolled. Finally, 65 patients remained in the no mesh group (Group A) and 70 in the mesh group (Group B) at 24 months with the most common reason for drop-out being death (n = 41). At 24 months, PSH was clinically detected in 28 patients (28%) in Group A and 30 (31%) in Group B [P = 0.77, odds ratio = 1.15 95% confidence interval = (0.62;2.13)]. Stoma-related complications were reported in 32 Group A patients and 37 Group B patients, but no mesh infections. There were no deaths related to mesh insertion. CONCLUSION: We failed to show efficiency of a prophylactic mesh on PSH rate. Placement of a mesh in a retro-muscular position with a central incision to allow colon passage cannot be recommended to prevent PSH. Optimization of mesh location and reinforcement material should be performed.

Impact of hospital volume on outcomes after emergency management of obstructive colon cancer: a nationwide study of 1957 patients.

PURPOSE: Volume-outcome relationship is well established in elective colorectal surgery for cancer, but little is known for patients managed for obstructive colon cancer (OCC). We aimed to compare the management and outcomes according to the hospital volume in this particular setting. METHODS: Patients managed for OCC between 2005 and 2015 in centers of the French National Surgical Association were retrospectively analyzed. Hospital volume was dichotomized between low and high volume on the median number of patients included per center during the study period. RESULTS: A total of 1957 patients with OCC were managed in 56 centers with a median number of 28 (1-123) patients per center: 298 (15%) were treated in low-volume hospitals (LVHs) and 1659 (85%) in high-volume hospitals (HVHs). Patients in LVH were significantly younger, and had fewer comorbidities and synchronous metastases. Proximal diverting stoma was the preferred surgical option in LVH (p < 0.0001), whereas tumor resection with primary anastomosis was more frequently performed in HVH (p < 0.0001). Cumulative morbidity (59 vs. 50%, p = 0.003), mortality (13 vs. 8%, p = 0.03), and length of hospital stay (22 ± 19 vs. 18 ± 14 days, p = 0.002) were significantly higher in LVH. At multivariate analysis, LVH was a predictor for cumulative morbidity (p < 0.0001) and mortality (p = 0.03). There was no difference between the two groups for tumor resection and stoma rates, and for oncological outcomes. CONCLUSIONS: The hospital volume has no impact on outcomes after the first-stage surgery in OCC patients. When all surgical stages are considered, hospital volume influences cumulative postoperative morbidity and mortality but has no impact on oncological outcomes.

30-Day Postoperative Morbidity of Emergency Surgery for Obstructive Right- and Left-Sided Colon Cancer in Obese Patients: A Multicenter Cohort Study of the French Surgical Association.

BACKGROUND: Emergency surgery impairs postoperative outcomes in colorectal cancer patients. No study has assessed the relationship between obesity and postoperative results in this setting. OBJECTIVE: To compare the results of emergency surgery for obstructive colon cancer (OCC) in an obese patient population with those in overweight and normal weight patient groups. METHODS: From 2000 to 2015, patients undergoing emergency surgery for OCC in French surgical centers members of the French National Surgical Association were included. Three groups were defined: normal weight (body mass index [BMI] < 25.0 kg/m2), overweight (BMI 25.0-29.9 kg/m2), and obese (BMI ≥30.0 kg/m2). RESULTS: Of 1,241 patients, 329 (26.5%) were overweight and 143 (11.5%) were obese. Obese patients had significantly higher American society of anesthesiologists score, more cardiovascular comorbidity and more hemodynamic instability at presentation. Overall postoperative mortality and morbidity were 8 and 51%, respectively, with no difference between the 3 groups. For obese patients with left-sided OCC, stoma-related complications were significantly increased (8 vs. 5 vs. 15%, p = 0.02). CONCLUSION: Compared with lower BMI patients, obese patients with OCC had a more severe presentation at admission but similar surgical management. Obesity did not increase 30-day postoperative morbidity except stoma-related complications for those with left-sided OCC.

What is the Best Option Between Primary Diverting Stoma or Endoscopic Stent as a Bridge to Surgery with a Curative Intent for Obstructed Left Colon Cancer? Results from a Propensity Score Analysis of the French Surgical Association Multicenter Cohort of 518 Patients.

BACKGROUND: Endoscopic stent (ES) as a bridge to surgery in obstructed left colon cancer (OLCC) is controversial. Our goal was to compare the operative and oncological results of primary diverting colostomy (PDC) and ES for the curative treatment of OLCC. METHODS: Between 2000 and 2015, patients who underwent PDC or ES in a curative intent for OLCC at member centers of the French Surgical Association were included. Patients with unresectable tumors and/or synchronous metastases were excluded. Comparisons between the two groups were performed after ponderation with propensity score for: demographic and tumor characteristics, operative, and oncological results. RESULTS: A total of 518 patients were included: PDC (n = 327); ES (n = 191). The demographic characteristics were similar between the groups. ES failed in 23% of the patients (11% perforation). Cumulative tumor resection rates were 80% and 86% after PDC and ES, respectively (p = 0.049). The rates of primary anastomosis were 57% in the PDC group and 40% in the ES group (p < 0.0001). The permanent stoma rates were similar between the two groups (29% vs. 28%, p = 0.0586). Cumulative overall, surgical, and medical complications were significantly higher in PDC group. The resected tumors were significantly smaller and less frequently perforated and metastatic in the PDC group. The median overall survival was significantly higher after PDC (123.6 vs. 58.5 months, p = 0.046), whereas the median disease-free survival was similar between the two groups (54.1 vs. 53.6 months, p = 0.646). CONCLUSIONS: Although endoscopic stenting is associated with better surgical outcomes than diverting stoma, it may negatively impact histological features and overall survival.

Emergency Surgery for Obstructive Colon Cancer in Elderly Patients: Results of a Multicentric Cohort of the French National Surgical Association.

BACKGROUND: Although elderly patients constitute most of the patients undergoing surgery for obstructed colon cancer, available data in the literature are very limited. OBJECTIVE: The purpose of this study was to assess the management and outcomes of elderly patients treated for obstructed colon cancer. DESIGN: This was a multicenter, retrospective cohort study. SETTINGS: Between 2000 and 2015, 2325 patients managed for an obstructed colon cancer in member centers of the French National Surgical Association were identified. Data were collected by each center on a voluntary basis after institutional approval. Bowel obstruction was defined clinically and confirmed by imaging. PATIENTS: Three age groups were defined, including patients <75 years, 75 to 84 years, and ≥85 years. MAIN OUTCOME MEASURES: Postoperative and oncologic results in elderly patients with an obstructed colon cancer were measured. Relative survival was calculated as the ratio of the overall survival with the survival that would have been expected based on the corresponding general population. INTERVENTIONS: A total of 302 patients (13%) underwent colonic stent insertion, and 1992 (87%) underwent surgery as emergency procedure. RESULTS: A total of 2294 patients were analyzed (<75 y, n = 1200 (52%); 75-84 y, n = 650 (28%); and ≥85 y, n = 444 (20%)). Elderly patients were more likely to be women (p < 0.0001), to have proximal colon cancer (p < 0.0001), and to have a higher incidence of comorbidities (p < 0.0001). The use of colonic stent or the type of surgery was identical regardless of age. In patients with resected colon cancer, elderly patients had less stage IV disease (p < 0.0001). The absence of tumor resection (p < 0.0001) and definitive stoma rate increased with age (p < 0.0001). Postoperative mortality and morbidity were significantly higher in elderly patients (p < 0.0001), but surgical morbidity was similar across age groups (p = 0.60). Postoperative morbidity was correlated to the 6-month mortality rate in elderly (p < 0.0001). Overall and disease-free survivals were significantly lower in more elderly patients (p < 0.0001) but relative survival was not (p = 0.09). LIMITATIONS: It is quite difficult to know how to interpret these data as a whole, given the inherent bias in the study population, lack of ability to stratify by performance status, and long study period duration. CONCLUSIONS: Elderly patients have high morbidity with lower survival in the highest age ranges of elderly subgroups. These data should be considered when deciding on an operative approach. See Video Abstract at http://links.lww.com/DCR/A964.

Right-sided vs. left-sided obstructing colonic cancer: results of a multicenter study of the French Surgical Association in 2325 patients and literature review.

PURPOSE: Few studies compared management and outcomes of obstructing colonic cancer (OCC), according to the tumor site. Our aim was to compare patient and tumor characteristics, postoperative and pathological results, and oncological outcomes after emergency management of right-sided vs. left-sided OCC. METHODS: A national cohort study including all consecutive patients managed for OCC from 2000 to 2015 in French surgical centers members of the French National Surgical Association (AFC). RESULTS: During the study period, 2325 patients with OCC were divided in right-sided (n = 819, 35%) and left-sided (n = 1506, 65%) locations. Patients with right-sided OCC were older, more frequently females, and associated with comorbidities, history of cancer, or previous laparotomy. Surgical management was more frequently performed for right-sided than left-sided OCC (99 vs. 96%, p < 0.0001). Tumor resection was more frequently performed in right-sided OCC (95 vs. 90%, p < 0.0001). Among the resected patients, primary anastomosis was more frequently performed in case of right-sided OCC (86 vs. 62%, p < 0.0001). Definitive stoma rate was lower in right-sided location (17 vs. 46%, p < 0.0001). There was no significant difference between locations in terms of cumulative morbidity, anastomotic leak, unplanned reoperation, and mortality. Five-year overall and disease-free survival rates were significantly lower in right-sided OCC (43 and 36%) than in left-sided OCC (53 and 46%, p < 0.0001 and p = 0.001, respectively). CONCLUSIONS: Although patients with right-sided OCC are frailer than left-sided OCC, tumor resection and anastomosis are more frequently performed, without difference in surgical results. However, right-sided OCC is associated with worse prognosis than distal location.

Prognostic factors and patterns of recurrence after emergency management for obstructing colon cancer: multivariate analysis from a series of 2120 patients.

PURPOSE: At equal TNM stage, obstructing colon cancer (OCC) is associated with worse prognosis in comparison with uncomplicated cancer. Our aim was to identify prognostic factors of overall (OS) and disease-free survival (DFS) in patients treated for OCC. METHODS: From 2000 to 2015, 2325 patients were treated for OCC in French surgical centers, members of the French National Surgical Association (AFC). Patients with palliative management were excluded. The main endpoints were OS and DFS. A multivariate analysis, using Cox proportional hazards regression model, was performed to determine independent prognostic factors. RESULTS: The cohort included 2120 patients. The median of follow-up was 13.2 months. In multivariate analysis, age > 75 years, ASA score ≥ 3, ECOG score ≥ 3, right-sided colon cancer, presence of synchronous metastases, anastomotic leakage, and absence of adjuvant chemotherapy were independent OS factors. Age > 75 years, ASA score ≥ 3, right-sided colon cancer, presence of synchronous metastases, and absence of postoperative chemotherapy were independent factors of poor OS after exclusion of patients who died postoperatively. Age ≥ 75 years, ASA score ≥ 3, ECOG score ≥ 3, right-sided colon cancer, lymph node involvement, presence of vascular, lymphatic or perineural invasion, less than 12 harvested lymph nodes, and absence of adjuvant chemotherapy were independent DFS factors. CONCLUSIONS: Management of OCC should take into account prognostic factors related to the patient (age, comorbidities), tumor location, and tumor stage. Adjuvant chemotherapy administration plays an important role. For patients undergoing initial defunctionning stoma, neoadjuvant chemotherapy could be an option to improve prognosis.

Is Sacral Nerve Modulation a Good Option for Fecal Incontinence in Men?

OBJECTIVE: The objective was to assess the efficacy and the safety of sacral nerve modulation (SNM) in men with fecal incontinence (FI) compared with those of SNM in women. METHOD: Prospectively collected data from patients from seven tertiary colorectal units who underwent an implant procedure between January 2010 and December 2015 were reviewed retrospectively. Outcomes and surgical revision and definitive explantation rates were compared between men and women. RESULTS: A total of 469 patients (60 men [12.8%]; mean age = 61.4 ± 12.0 years) were included in the study, 352 (78.1%) (31 men [8.8%]) of whom received a permanent implant. The ratio of implanted/tested men was significantly lower than the ratio of implanted/tested women (p = 0.0004). After a mean follow-up of 3.4 ± 1.9 years, the cumulative successful treatment rates tended to be less favorable in men than in women (p = 0.0514): 88.6% (75.6-95.1), 75.9% (60.9-86.4), 63.9% (48.0-77.3), and 43.9% (26.7-62.7) at one, two, three, and five years, respectively, in men; 92.0% (89.1-94.2), 84.2% (80.3-87.4), 76.8% (72.3-80.7), and 63.6% (57.5-69.3) at one, two, three, and five years, respectively, in women. The revision rate for infection and the definitive explantation rate for infection were higher in men than in women (p = 0.0001 and p = 0.0024, respectively). CONCLUSION: Both short- and long-term success rates of SNM for FI were lower in men than in women. The revision and definitive explantation for long-term infection rates were significantly higher in men.

Embolization of the Superior Rectal Arteries for Hemorrhoidal Disease: Prospective Results in 25 Patients.

PURPOSE: To evaluate efficacy and safety of superior rectal artery embolization of hemorrhoidal disease as a first-line invasive treatment. MATERIALS AND METHODS: This prospective study was conducted between 2014 and 2015 on 25 consecutive patients (16 men and 9 women with a mean age of 53 y [range, 30-76 y]) with grade II-III hemorrhoids refractory to medical treatment. A transfemoral superselective superior rectal artery branch embolization was performed using 2- and 3-mm diameter microcoils. Over the following 12 months, clinical outcomes were evaluated using the French bleeding score, Goligher prolapse score, visual analog scale (VAS) score for pain, quality-of-life score. The primary endpoint was relief of symptoms by 12 months based on a 2-point minimum improvement on VAS score and bleeding score. RESULTS: At 12 months after embolization, clinical success was obtained in 18 patients (72%), 8 of whom had 2 embolizations. VAS score decreased from 4.6 to 2.3 (P < .01), and bleeding score decreased from 5.5 to 2.3 (P < .01). Quality-of-life and prolapse scores also showed improvement (P < .05), and no patients experienced any early or late complications. Complete clinical failure was observed in 7 patients. After coil embolization, the collateral supply to the hemorrhoidal cushions was significantly related to any recurrence (P = .001). CONCLUSIONS: Hemorrhoidal artery coil embolization was found to be a safe and effective treatment for grade II-III hemorrhoids.

A comparison of surgical devices for grade II and III hemorrhoidal disease. Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy.

PURPOSE: Little is presently known on the impact of device type for Doppler-guided hemorrhoidal artery ligation/mucopexy (DGHAL) or circular stapled hemorrhoidopexy (CSH) when a surgical treatment is considered for hemorrhoidal disease (HD). In this study, we aimed to compare the outcome in terms of adverse events and recurrence rate, of patients included in the multicenter LigaLongo RCT ( ClinicalTrials.gov NCT01240772) according to the type of devices used. METHODS: In the DGHAL arm (N = 193), the procedure was done with transanal hemorrhoidal dearterialization (THD)™ (THD, Correggio, Italy) (104 patients) and with HAL-RAR™ (Agency for Medical Innovations (AMI) GmbH, Feldkirch, Austria) (89 patients). In the CSH arm (N = 184), procedure for prolapse and hemorrhoids (PPH)-03™ (Ethicon Endo-Surgery, Cincinnati OH) and hemorrhoidopexy and prolapse (HEM)™ (Covidien, Inc.) staplers were used in respectively 106 and 78 cases. Surgery-related morbidity at 90 postoperative days (POD) based on the Clavien-Dindo procedure-related complication score and clinical outcome in terms of recurrence and reoperation rate at 12 postoperative months (POM) was collected. RESULTS: Three hundred and seventy-seven patients were randomized according to HD grade. In the DGHAL arm, the number of ligations and mucopexies was higher in the AMI group (p < 0.0001); at 90 POD, the overall morbidity was similar between the two groups. In the CSH arm, donut sizes were similar; at 90 POD, the PPH group had a higher risk of postoperative grade 1 morbidity (anal urgency or incontinence) compared to the HEM group (p = 0.003). At 12 POM, no statistical difference was found between the two groups of each arm in terms of grade III recurrence or reoperation. CONCLUSION: Postoperative morbidity and outcome at 1 year were similar regardless of the type of devices used. These findings suggest that device type has little impact on HD treatment results. TRIAL REGISTRATION: clinicaltrials.gov -Identifier NCT01240772.

To Drain or Not to Drain Infraperitoneal Anastomosis After Rectal Excision for Cancer: The GRECCAR 5 Randomized Trial.

OBJECTIVE: To assess the effect of pelvic drainage after rectal surgery for cancer. BACKGROUND: Pelvic sepsis is one of the major complications after rectal excision for rectal cancer. Although many studies have confirmed infectiveness of drainage after colectomy, there is still a controversy after rectal surgery. METHODS: This multicenter randomized trial with 2 parallel arms (drain vs no drain) was performed between 2011 and 2014. Primary endpoint was postoperative pelvic sepsis within 30 postoperative days, including anastomotic leakage, pelvic abscess, and peritonitis. Secondary endpoints were overall morbidity and mortality, rate of reoperation, length of hospital stay, and rate of stoma closure at 6 months. RESULTS: A total of 494 patients were randomized, 25 did not meet the criteria and 469 were analyzed: 236 with drain and 233 without. The anastomotic height was 3.5 ±â€Š1.9 cm from the anal verge. The rate of pelvic sepsis was 17.1% (80/469) and was similar between drain and no drain: 16.1% versus 18.0% (P = 0.58). There was no difference of surgical morbidity (18.7% vs 25.3%; P = 0.83), rate of reoperation (16.6% vs 21.0%; P = 0.22), length of hospital stay (12.2 vs 12.2; P = 0.99) and rate of stoma closure (80.1% vs 77.3%; P = 0.53) between groups. Absence of colonic pouch was the only independent factor of pelvic sepsis (odds ratio = 1.757; 95% confidence interval 1.078-2.864; P = 0.024). CONCLUSIONS: This randomized trial suggests that the use of a pelvic drain after rectal excision for rectal cancer did not confer any benefit to the patient.

Temporary successful results of ventral rectopexy for enterocele surgical correction, about 138 patients.

PURPOSE: This work aimed to analyse short- and long-term results of enterocele surgical treatment by ventral rectopexy. METHODS: All females who underwent ventral rectopexy for enterocele in our department were included. All patients underwent standardized preoperative evaluation. Data was retrospectively collected, after examination of patients or by telephone survey. Postoperative evaluation was performed by an independent observer. RESULTS: One hundred thirty-eight females (median age = 63 years [21-86 years]) were included. They were postmenopausal and multiparous in 94 and 70% of cases, respectively. Pelvic pressure, vaginal prolapse, or the both were observed in 28, 16 or 56% of the patients, respectively. The most frequent associated symptoms were dyschezia (63%) and faecal incontinence (30%). On preoperative workup, enterocele was isolated in two cases. Rectocele, internal rectal prolapse and cervicocystoptosis were the most frequently associated pelvic floor disorders. Ventral rectopexy was performed through laparoscopy in 128 patients (93%). In the short term, all pelvic symptoms were significantly improved, except urinary incontinence. At the end of follow-up (56 months [7-125]), specific symptoms and dyschezia were still significantly improved. Secondary failure was reported in 31% of patients. By multivariate analysis, two predictive factors for long-term failure were found: diagnosis of rectocele on preoperative MRI (odd ratio = 15; 95% CI 1.4-163; p = 0.03) and conversion into open surgery (odd ratio = 8; 95% CI 1.4-43; p = 0.02). CONCLUSION: This study suggests that ventral rectopexy is an effective treatment of enterocele, but secondary failure can be observed. Patients should be informed of the potential risk of long-term degradation.

The origin and concentration of circulating microparticles differ according to cancer type and evolution: A prospective single-center study.

Microparticles are plasma membrane vesicles produced by apoptotic or activated cells and resting cancer cells. The concentration, origin and procoagulant properties of circulating microparticles are reported to differ according to pathological settings (inflammation, cancer and cardiovascular diseases). In case of cancer, different studies have reported a variation in the concentration of circulating microparticles, with an increase in procoagulant and tumor-associated antigen-bearing microparticles. However, the cancer specificity of these results remains unknown. The objective was to establish a specific signature of colorectal and pancreatic cancers (CRC, PC) by characterizing circulating microparticles. Patients presenting with CRC, PC, inflammatory bowel or pancreatic diseases, and healthy subjects, were prospectively included. Circulating microparticles were analyzed by flow cytometry, combining the analysis of Annexin V-positive with characterization of their origin and determination of their procoagulant activities. We included 85, 36, 15, 18 and 20 patients presenting with CRC, PC, inflammatory bowel or pancreatic diseases, and healthy subjects, respectively. Here, we depict a specific signature, which differed between CRC, PC, associated inflammatory bowel and pancreatic diseases and healthy subjects. Furthermore, in patients with remission, this signature returned to the levels observed in associated inflammatory or healthy patients. Our results indicate that circulating microparticles differ depending on the evolution of a cancer. The analysis of the circulating microparticles reveals the specificity of the signature and can be used as a new complex biomarker reflecting the evolution of the disease.

Early Enteral Versus Total Parenteral Nutrition in Patients Undergoing Pancreaticoduodenectomy: A Randomized Multicenter Controlled Trial (Nutri-DPC).

OBJECTIVES: The aim of this study was to compare nasojejunal early enteral nutrition (NJEEN) with total parenteral nutrition (TPN), after pancreaticoduodenectomy (PD), in terms of postoperative complications. BACKGROUND: Current nutritional guidelines recommend the use of enteral over parenteral nutrition in patients undergoing gastrointestinal surgery. However, the NJEEN remains controversial in patients undergoing PD. METHODS: Multicenter, randomized, controlled trial was conducted between 2011 and 2014. Nine centers in France analyzed 204 patients undergoing PD to NJEEN (n = 103) or TPN (n = 101). Primary outcome was the rate of postoperative complications according to Clavien-Dindo classification. Successful NJEEN was defined as insertion of a nasojejunal feeding tube, delivering at least 50% of nutritional needs on PoD 5, and no TPN for more than consecutive 48 hours. RESULTS: Postoperative complications occurred in 77.5% [95% confidence interval (95% CI) 68.1-85.1] patients in the NJEEN group versus 64.4% (95% CI 54.2-73.6) in TPN group (P = 0.040). NJEEN was associated with higher frequency of postoperative pancreatic fistula (POPF) (48.1% vs 27.7%, P = 0.012) and higher severity (grade B/C 29.4% vs 13.9%; P = 0.007). There was no significant difference in the incidence of post-pancreatectomy hemorrhage, delayed gastric emptying, infectious complications, the grade of postoperative complications, and the length of postoperative stay. A successful NJEEN was achieved in 63% patients. In TPN group, average energy intake was significantly higher (P < 0.001) and patients had an earlier recovery of oral feeding (P = 0.0009). CONCLUSIONS: In patients undergoing PD, NJEEN was associated with an increased overall postoperative complications rate. The frequency and the severity of POPF were also significantly increased after NJEEN. In terms of safety and feasibility, NJEEN should not be recommended.

Impact of venous thromboembolism on the natural history of pancreatic adenocarcinoma.

BACKGROUND: Few studies have analyzed the effect of venous thromboembolism (VTE) events on the prognosis of pancreatic cancer, but their results were conflicting. The present study was undertaken to determine the effect of VTE on pancreatic adenocarcinoma (PA) outcomes. METHODS: All consecutive patients diagnosed with PA from May 2004 to January 2012 in a single oncology center were retrospectively studied. Clinical, radiological and histological data at time of diagnosis or within the first 3 months after surgery, including the presence (+) or absence (-) of VTE were collected. VTE was defined as radiological evidence of either pulmonary embolism (PE), deep venous thrombosis without infection or catheter-related thrombosis. PA with and without PE was compared for survival using the Kaplan-Meier method to estimate overall survival. RESULTS: Among 162 PA patients with a median follow-up of 15 (3-92) months after diagnosis, 28 demonstrated VTE (+). PA patients with and without PE were similar for age, American Society of Anesthesiologist score, body mass index, and history of treatment. The distribution of cancer stages was similar between the two groups VTE (+) and VTE (-). The median duration of survival was significantly worse in the VTE (+) group vs VTE (-) (12 vs 18 months, P=0.010). In multivariate analysis, the presence of VTE and surgical treatment were independent prognostic factors for overall survival. CONCLUSION: VTE (+) at time of diagnosis or within the first 3 months after surgery during treatment is an independent factor of poor prognosis in PA.

Effect of postoperative antibiotic administration on postoperative infection following cholecystectomy for acute calculous cholecystitis: a randomized clinical trial.

IMPORTANCE: Ninety percent of cases of acute calculous cholecystitis are of mild (grade I) or moderate (grade II) severity. Although the preoperative and intraoperative antibiotic management of acute calculous cholecystitis has been standardized, few data exist on the utility of postoperative antibiotic treatment. OBJECTIVE: To determine the effect of postoperative amoxicillin plus clavulanic acid on infection rates after cholecystectomy. DESIGN, SETTING, AND PATIENTS: A total of 414 patients treated at 17 medical centers for grade I or II acute calculous cholecystitis and who received 2 g of amoxicillin plus clavulanic acid 3 times a day while in the hospital before and once at the time of surgery were randomized after surgery to an open-label, noninferiority, randomized clinical trial between May 2010 and August 2012. INTERVENTIONS: After surgery, no antibiotics or continue with the preoperative antibiotic regimen 3 times daily for 5 days. MAIN OUTCOMES AND MEASURES: The proportion of postoperative surgical site or distant infections recorded before or at the 4-week follow-up visit. RESULTS: An imputed intention-to-treat analysis of 414 patients showed that the postoperative infection rates were 17% (35 of 207) in the nontreatment group and 15% (31 of 207) in the antibiotic group (absolute difference, 1.93%; 95% CI, -8.98% to 5.12%). In the per-protocol analysis, which involved 338 patients, the corresponding rates were both 13% (absolute difference, 0.3%; 95% CI, -5.0% to 6.3%). Based on a noninferiority margin of 11%, the lack of postoperative antibiotic treatment was not associated with worse outcomes than antibiotic treatment. Bile cultures showed that 60.9% were pathogen free. Both groups had similar Clavien complication severity outcomes: 195 patients (94.2%) in the nontreatment group had a score of 0 to I and 2 patients (0.97%) had a score of III to V, and 182 patients (87.8%) in the antibiotic group had a score of 0 to I and 4 patients (1.93%) had a score of III to V. CONCLUSIONS AND RELEVANCE: Among patients with mild or moderate calculous cholecystitis who received preoperative and intraoperative antibiotics, lack of postoperative treatment with amoxicillin plus clavulanic acid did not result in a greater incidence of postoperative infections. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01015417.

Outcome and cost analysis of sacral nerve modulation for treating urinary and/or fecal incontinence.

BACKGROUND: Sacral nerve modulation (SNM) is an established treatment for urinary and fecal incontinence in patients for whom conservative management has failed. OBJECTIVE: This study assessed the outcome and cost analysis of SNM compared to alternative medical and surgical treatments. METHODS: Clinical outcome and cost-effectiveness analyses were performed in parallel with a prospective, multicenter cohort study that included 369 consecutive patients with urge urinary and/or fecal incontinence. The duration of follow-up was 24 months, and costs were estimated from the national health perspective. Cost-effectiveness outcomes were expressed as incremental costs per 50% of improved severity scores (incremental cost-effectiveness ratio). RESULTS: The SNM significantly improved the continence status (P < 0.005) and quality of life (P < 0.05) of patients with urge urinary and/or fecal incontinence compared to alternative treatments. The average cost of SNM for urge urinary incontinence was ∈8525 (95% confidence interval, ∈6686-∈10,364; P = 0.001) more for the first 2 years compared to alternative treatments. The corresponding increase in cost for subjects with fecal incontinence was ∈6581 (95% confidence interval, ∈2077-∈11,084; P = 0.006). When an improvement of more than 50% in the continence severity score was used as the unit of effectiveness, the incremental cost-effectiveness ratio for SNM was ∈94,204 and ∈185,160 at 24 months of follow-up for urinary and fecal incontinence, respectively. CONCLUSIONS: The SNM is a cost-effective treatment for urge urinary and/or fecal incontinence.

Rationale for possible targeting of histone deacetylase signaling in cancer diseases with a special reference to pancreatic cancer.

There is ongoing interest to identify signaling pathways and genes that play a key role in carcinogenesis and the development of resistance to antitumoral drugs. Given that histone deacetylases (HDACs) interact with various partners through complex molecular mechanims leading to the control of gene expression, they have captured the attention of a large number of researchers. As a family of transcriptional corepressors, they have emerged as important regulators of cell differentiation, cell cycle progression, and apoptosis. Several HDAC inhibitors (HDACis) have been shown to efficiently protect against the growth of tumor cells in vitro as well as in vivo. The pancreatic cancer which represents one of the most aggressive cancer still suffers from inefficient therapy. Recent data, although using in vitro tumor cell cultures and in vivo chimeric mouse model, have shown that some of the HDACi do express antipancreatic tumor activity. This provides hope that some of the HDACi could be potential efficient anti-pancreatic cancer drugs. The purpose of this review is to analyze some of the current data of HDACi as possible targets of drug development and to provide some insight into the current problems with pancreatic cancer and points of interest for further study of HDACi as potential molecules for pancreatic cancer adjuvant therapy.

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for resectable peritoneal metastases is feasible in elderly patients.

The aim is to evaluate the feasibility and the prognosis of cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) for resectable peritoneal metastases (RPM) in elderly patients. Patients who underwent CRS with HIPEC for RPM between 2012 and 2018 in one tertiary reference center were retrospectively included and divided according to the age: Group A (< 65 years) and Group B (≥ 65 years). Postoperative outcomes and survivals were compared. Ninety-five patients were included in Groups A (n = 65) and B (n = 30). The incidence of comorbidities was significantly higher in elderly patients (65 vs 90%, p = 0.01), but RPM characteristics were similar between groups. There was no difference between groups in terms of postoperative results: 30-day major morbidity (33 vs 23%, p = 0.4), 30-day mortality (0 vs 3%, p = 0.3), mean length of stay (26.7 ± 19.4 vs 22.4 ± 10.3 days, p = 0.3) and readmission's rate (15 vs 33%, p = 0.06). The only one significant difference was the 90-day mortality which never occurred before 65 years but in 10% of elderly patients (p = 0.03). There was no difference regarding recurrence's rate (56 vs 37%, p = 0.1), neither 1-, 3- and 5-year overall survival rates (86, 64 and 52% vs 85, 74% and not reached, p = 0.8) and disease-free survival rates (61, 28 and 28% vs 56, 45% and not reached, p = 0.6). CRS with HIPEC is feasible in elderly patients. Since the 90-day mortality appeared to be higher in elderly patients, additional criteria are necessary to improve the selection of elderly patients for this major surgery.