Suprapubic versus transurethral catheterization for bladder drainage in male rectal cancer surgery (GRECCAR10), a randomized clinical trial.

BACKGROUND: Bladder drainage is systematically used in rectal cancer surgery; however, the optimal type of drainage, transurethral catheterization (TUC) or suprapubic catheterization (SPC), is still controversial. The aim was to compare the rates of urinary tract infection on the fourth postoperative day (POD4) between TUC and SPC, after rectal cancer surgery regardless of the day of removal of the urinary drain. METHODS: This randomized clinical trial in 19 expert colorectal surgery centers in France and Belgium was performed between October 2016 and October 2019 and included 240 men (with normal or subnormal voiding function) undergoing mesorectal excision with low anastomosis for rectal cancer. Patients were followed at postoperative days 4, 30, and 180. RESULTS: In 208 patients (median age 66 years [IQR 58-71]) randomized to TUC (n = 99) or SPC (n = 109), the rate of urinary infection at POD4 was not significantly different whatever the type of drainage (11/99 (11.1%) vs. 8/109 (7.3%), 95% CI, - 4.2% to 11.7%; p = 0.35). There was significantly more pyuria in the TUC group (79/99 (79.0%) vs. (60/109 (60.9%), 95% CI, 5.7-30.0%; p = 0.004). No difference in bacteriuria was observed between the groups. Patients in the TUC group had a shorter duration of catheterization (median 4 [2-5] vs. 4 [3-5] days; p = 0.002). Drainage complications were more frequent in the SPC group at all followup visits. CONCLUSIONS: TUC should be preferred over SPC in male patients undergoing surgery for mid and/or lower rectal cancers, owing to the lower rate of complications and shorter duration of catheterization. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02922647.

Risk factors for severe morbidity and definitive stoma after elective surgery for sigmoid diverticulitis: a multicenter national cohort study.

BACKGROUND: In the decision to perform elective surgery, it is of great interest to have data about the outcomes of surgery to individualize patients who could safely undergo sigmoid resection. The aim of this study was to provide information on the outcomes of elective sigmoid resection for sigmoid diverticular disease (SDD) at a national level. METHODS: All consecutive patients who had elective surgery for SDD (2010-2021) were included in this retrospective, multicenter, cohort study. Patients were identified from institutional review board-approved databases in French member centers of the French Surgical Association. The endpoints of the study were the early and the long-term postoperative outcomes and an evaluation of the risk factors for 90-day severe postoperative morbidity and a definitive stoma after an elective sigmoidectomy for SDD. RESULTS: In total, 4617 patients were included. The median [IQR] age was 61 [18.0;100] years, the mean ± SD body mass index (BMI) was 26.8 ± 4 kg/m2, and 2310 (50%) were men. The indications for surgery were complicated diverticulitis in 50% and smoldering diverticulitis in 47.4%. The procedures were performed laparoscopically for 88% and with an anastomosis for 83.8%. The severe complication rate on postoperative day 90 was 11.7%, with a risk of anastomotic leakage of 4.7%. The independent risk factors in multivariate analysis were an American Society of Anesthesiologists (ASA) score ≥ 3, an open approach, and perioperative blood transfusion. Age, perioperative blood transfusion, and Hartmann's procedure were the three independent risk factors for a permanent stoma. CONCLUSIONS: This series provides a real-life picture of elective sigmoidectomy for SDD at a national level. TRIAL REGISTRATION: Comité National Information et Liberté (CNIL) (n°920361).

Study of surfactant cross-linking by click chemistry on a model water/oil interface.

In this study, we explored how chemical reactions of amphiphile compounds can be characterized and followed-up on model interfaces. A custom-made surfactant containing three alkyne sites was first adsorbed and characterized at a water/oil interface. These amphiphiles then underwent interfacial crosslinking by click chemistry upon the addition of a second reactive agent. The monolayer properties and dilatational elasticity, were compared before and after the polymerization. Using bulk phase exchange, the composition of the aqueous bulk phase was finely controlled and washed to specifically measure the interfacial effects of the entities adsorbed and trapped at the interface. In this study, we aim to emphasize an original experimental approach to follow complex phenomena occurring on model interfaces, and also show the potential of this method to characterize multifactorial processes.

A Reappraisal of Outcome of Elective Surgery After Successful Non-Operative Management of an Intra-Abdominal Abscess Complicating Ileocolonic Crohn's Disease: A Subgroup Analysis of a Nationwide Prospective Cohort.

BACKGROUND AND AIMS: Few prospective data exist on outcomes of surgery in Crohn's disease [CD] complicated by an intra-abdominal abscess after resolution of this abscess by antibiotics optionally combined with drainage. METHODS: From 2013 to 2015, all patients undergoing elective surgery for CD after successful non-operative management of an intra-abdominal abscess [Abscess-CD group] were selected from a nationwide multicentre prospective cohort. Resolution of the abscess had to be computed tomography/magnetic resonance-proven prior to surgery. Abscess-CD group patients were 1:1 matched to uncomplicated CD [Non-Penetrating-CD group] using a propensity score. Postoperative results and long-term outcomes were compared between the two groups. RESULTS: Among 592 patients included in the registry, 63 [11%] fulfilled the inclusion criteria. The abscess measured 37 ±â€…20 mm and was primarily managed with antibiotics combined with drainage in 14 patients and nutritional support in 45 patients. At surgery, a residual fluid collection was found in 16 patients [25%]. Systemic steroids within 3 months before surgery [p = 0.013] and the absence of preoperative enteral support [p = 0.001] were identified as the two significant risk factors for the persistence of a fluid collection. After propensity score matching, there was no significant difference between the Abscess-CD and Non-Penetrating-CD groups in the rates of primary anastomosis [84% vs 90% respectively, p = 0.283], overall [28% vs 15% respectively, p = 0.077] and severe postoperative morbidity [7% vs 7% respectively, p = 1.000]. One-year recurrence rates for endoscopic recurrence were 41% in the Abscess-CD and 51% in the Non-Penetrating-CD group [p = 0.159]. CONCLUSIONS: Surgery after successful non-operative management of intra-abdominal abscess complicating CD provides good early and long-term outcomes.

Embarazo y nuevo coronavirus: experiencia global reportada / Pregnancy and novel coronavirus: worldwide reported experience

INTRODUCCIÓN: La Organización Mundial de La Salud ha reportado recientemente que el nuevo foco de la pandemia global de la enfermedad Covid-19 es el continente americano. OBJETIVO: Realizar una revisión de la literatura sobre la experiencia internacional de la pandemia Covid 19 y embarazo. MÉTODO: Se realiza una búsqueda de la base de datos PubMed para las palabras clave Pregnancy / Pregnant / Novel Coronavirus / SARS-CoV-2 / Covid-19, desde el 1 de noviembre 2019 hasta el 21 de mayo 2020. RESULTADOS: Un total de 365 artículos fueron inicialmente seleccionados de acuerdo con la estrategia de búsqueda diseñada. El total de artículos revisados de acuerdo con los criterios fueron 42. Las series clínicas seleccionadas acumularon un total de 1098 embarazadas y enfermedad de Covid-19. Las co-morbilidades mas frecuentes fueron hipertensión arterial, diabetes mellitus, obesidad y asma. La mortalidad en relación con el total de pacientes fue de un 1,2 % y la transmisión al recién nacido de 1,7% (15 de 875). CONCLUSIÓN: La información obtenida permite inferir que la presentación clínica de la enfermedad es a lo menos equivalente a la de mujeres de la misma edad no embarazadas. Dada la severidad de la enfermedad por SARS-CoV-2 reportada, las lecciones aprendidas deben ser rápidamente asimiladas y utilizadas en el contexto de la situación nacional epidémica.

INTRODUCTION: The World Health Organization has recently reported that the new focus of the global pandemic of Covid-19 disease is the American continent. OBJECTIVE: To conduct a literature review on the international experience of the Covid 19 pandemic and pregnancy. METHOD: A PubMed database search is performed for the keywords Pregnancy / Pregnant / Novel Coronavirus / SARS-CoV-2 / Covid-19, from November 1, 2019 to May 21, 2020. RESULTS: A total of 365 articles were initially selected according to the designed search strategy. The total of articles reviewed according to the criteria was 42. The selected clinical series accumulated a total of 1098 pregnant women and Covid-19 disease. The most frequent comorbidities were hypertension, diabetes mellitus, obesity, and asthma. Mortality in relation to the total number of patients was 1.2% and transmission to the newborn was 1.7% (15 of 875). CONCLUSION: The information obtained allows us to infer that the clinical presentation of the disease is at least equivalent to that of non-pregnant women of the same age. Given the severity of the reported SARS-CoV-2 disease, the lessons learned must be quickly assimilated and used in the context of the national epidemic situation.

Risk Factors for Small Bowel Obstruction After Laparoscopic Ileal Pouch-Anal Anastomosis for Inflammatory Bowel Disease: A Multivariate Analysis in Four Expert Centres in Europe.

BACKGROUND AND AIMS: Although laparoscopy is associated with a reduction in adhesions, no data are available about the risk factors for small bowel obstruction [SBO] after laparoscopic ileal pouch-anal anastomosis [IPAA]. Our aims here were to identify the risk factors for SBO after laparoscopic IPAA for inflammatory bowel disease [IBD]. METHODS: All consecutive patients undergoing laparoscopic IPAA for IBD in four European expert centres were included and divided into Groups A [SBO during follow-up] and B [no SBO]. RESULTS: From 2005 to 2015, SBO occurred in 41/521 patients [Group A; 8%]. Two-stage IPAA was more frequently complicated by SBO than 3- and modified 2-stage IPAA [12% vs 7% and 4%, p = 0.04]. After multivariate analysis, postoperative morbidity (odds ratio [OR] = 3, 95% confidence interval [CI] = 1.5-7, p = 0.002), stoma-related complications [OR = 3, 95% CI = 1-6, p = 0.03] and long-term incisional hernia [OR = 6, 95% CI = 2-18, p = 0.003] were predictive factors for SBO, while subtotal colectomy as first surgery was an independent protective factor [OR = 0.4, 95% CI = 0.2-0.8, p = 0.002]. In the subgroup of patients receiving restorative proctocolectomy as first operation, stoma-related or other surgical complications and long-term incisional hernia were predictive of SBO. In the patient subgroup of subtotal colectomy as first operation, postoperative morbidity and long-term incisional hernia were predictive of SBO, whereas ulcerative colitis and a laparoscopic approach during the second surgical stage were protective factors. CONCLUSIONS: We found that SBO occurred in less than 10% of patients after laparoscopic IPAA. The study also suggested that modified 2-stage IPAA could potentially be safer than procedures with temporary ileostomy [2- and 3-stage IPAA] in terms of SBO occurrence.

Mid term functional results following surgical treatment of recto-urinary fistulas postprostate cancer treatment.

INTRODUCTION: To evaluate the mid term functional results of patients treated for RUF and to determine an optimal treatment strategy to improve their quality of life. Recto-urinary Fistula (RUF) is a rare complication following prostate cancer treatment, and can have a major impact on patients' quality of life. There is a lack of consensus concerning the best approach and different techniques have been proposed: endoscopic, transrectal, perineal and transperitoneal (open, laparoscopic or robotic). MATERIALS AND METHODS: We retrospectively reviewed the charts of patients who underwent RUF repair from January 2001 to December 2010 at our Institute. 16 patients who developed RUF following prostate cancer treatment were included in the study. The fistula had to be confirmed both clinically and by imaging. All patients had follow up consultation every 3 month for the first year and then annually. They were asked to fill questionnaires evaluating functional outcomes. The International Continence Society (ICS) score was used to assess the postoperative urinary continence. Fecal continence was evaluated with the Wexner score and sexual function was assessed with the International Index for erectile function (IIEF-5) score. RESULTS: Eighty-seven percent patients (14/16) in our series developed RUF as a consequence of prostate cancer surgery and 13% (2/16) postbrachytherapy (BT). All patients initially had a diversion colostomy and a supra pubic catheter. 69% (11/16) underwent primary YM repair and 73% (8/11) were successful. 2/3 primary failures were successfully retreated with graciloplasty. Primary gracilis flap interposition (GFI), on 3 non-irradiated patients were successful (100%). Primary GFI postbrachytherapy, no patient had recover urinary and digestive continuity. In total primary GIF was successful in 60% (3/5). Over all long term, success rate with a urinary and digestive continuity and without recurrence of the fistula was 81% (13/16). Mid term functional results were evaluated at mean follow up of 40 months (14-92). 13% (2/16) achieved complete urinary continence, 48% (7/16) required single pad, 25% (4/16) developed major incontinence, 7% (1/16) required urinary diversion and 13% (2/16) developed complete urethral closure post BT requiring permanent suprapubic catheterization. Colostomy was reversed in 93% (15/16) cases. 75% (12/16) achieved complete faecal continence, minor incontinence (wexner score 3-4) was seen in 13% (2/16) and major incontinence (wexner score 14) in 7% (1/16) and 7% (1/16) required a long term colostomy. 19% (3/16) developed colostomy related complications. Only 13% (2/16) achieved adequate erections with the use of intra cavernosal prostaglandin injections. CONCLUSIONS: RUF following prostate cancer treatment is a serious complication with severe repercussion on patients' quality of life. Surgical repair with the York Mason technique or Gracilis Flap interposition is associated with good success rates. If available pediculed gracilis muscle should be used as it offers better success rates. LEVEL OF EVIDENCE: 3.

Outcome of restorative proctocolectomy with an ileo-anal pouch for ulcerative colitis: effect of changes in clinical practice.

AIM: Surgery for ileal pouch-anal anastomosis (IPAA) has evolved over time, especially since the introduction of laparoscopy. The aim of this retrospective study was to report the impact of surgical evolution on outcome over a period of 25 years. METHOD: All patients who had IPAA surgery for ulcerative colitis from 1990 to 2015 at the University Hospitals of Leuven were included. Patients were divided into three period arms (period A 1990-1999; period B 2000-2009; period C 2010-2015). The main outcome measure was anastomotic leakage. RESULTS: A total of 335 patients (58.8% male) with a median age of 39 years (interquartile range 32-49 years) at surgery were included. Median follow-up was 5 years (interquartile range 2-10 years). Overall anastomotic leakage (grades A-C) was 14.9%. A significant decrease in leakage rate was observed over time (from 21.4% in period A to 12.1% in period B to 10.0% in period C; P = 0.04). The defunctioning ileostomy rate at the time of pouch construction decreased from 91.7% (period A) to 40.3% (period B) to 11.1% (period C) (P < 0.001). We observed an increase in the use of laparoscopy (23.9% in period A vs 72.6% in period B, vs 84.4% in period C; P = 0.001) and a shift to a modified two-stage procedure (4.1% in period A, vs 66.7% in period C; P < 0.0001). In a monocentric study with some of the data retrieved retrospectively it was not possible to account for the impact of preoperative nutritional status (weight loss, serum albumin level) or disease burden. Other outcome factors were not measured, for example sexual function and fecundity. CONCLUSION: A higher rate of laparoscopic IPAA surgery, together with a shift towards modified two-stage procedures, was associated with a lower leakage rate despite a reduction in the use of defunctioning ileostomy.

Robot-assisted adrenalectomy: indications and drawbacks.

Adrenal tumors can vary from a benign adrenocortical adenoma with no hormonal secretion to a secretory adrenocortical malignancy (adrenocortical carcinoma) or a hormone-secreting tumor of the adrenal medulla (pheochromocytoma). Currently, laparoscopic adrenalectomy is regarded as the preferred surgical approach for the management of most adrenal surgical disorders, although there are no prospective randomized trials comparing this technique with open adrenalectomy. However, widespread adoption of robotic technology has positioned robotic adrenalectomy as an option in some medical centers. Speculative advantages associated with the use of the robotic system have rarely been evaluated in clinical settings and cost increase remains an important drawback associated with robotic surgery. This review summarizes current available data regarding robotic transperitoneal adrenalectomy including its indications, advantages, limitations, and comparison with conventional laparoscopic adrenalectomy. We believe that the use of a robotic system seems to be useful especially in more difficult patients with larger tumors, truncal paragangliomas, and bilateral and/or partial adrenalectomies. Overall, we believe that overcosts due to robotic system use could be balanced by hospital stay decrease, patients' referral increase, improved postoperative outcomes in more difficult patients and ergonomics for the surgeon. However, we also believe that the current surgical intuitive business model is counterproductive, because there are no available strong clinical data that could balance overcosts associated with the use of the robotic system.

Can contrast-enhanced MRI with gadoxetic acid predict liver failure and other complications after major hepatic resection?

AIM: To determine whether a combination of clinical factors, the future liver remnant (FLR) ratio, and hepatic uptake of gadoxetic acid can be used to predict post-hepatectomy liver failure (PHLF) and other major complications (OMC). MATERIALS AND METHODS: Sixty-five consecutive patients who underwent pre-hepatectomy gadoxetic acid-enhanced magnetic resonance imaging (MRI) between October 2010 and December 2013 were included. The relative liver enhancement (RLE) of gadoxetic acid was calculated from regions of interest on MRI, and FLR ratios were obtained from computed tomography (CT). PHLF and OMC were defined by the International Study Group of Liver Surgery criteria and Clavien-Dindo grade of ≥3, respectively. Multivariate logistic regression modelling was performed to identify predictors of PHLF and OMC, including RLE, FLR ratio, age, sex, chemotherapy history, intra-operative blood loss, and intra-operative transfusion. RESULTS: Nine patients experienced PHLF and another nine patients experienced OMC. RLE was comparable to the FLR ratio in predicting PHLF (areas under the receiver operating characteristic [AUROC] curves, 0.665 and 0.705), but performed poorly in predicting OMCs (AUROCs, 0.556 and 0.702). Combining all clinical and imaging parameters as predictors yielded the best performing predictive models (AUROCs, 0.875 and 0.742 for PHLF and OMC, respectively). CONCLUSION: A model based on clinical parameters, the FLR ratio, and RLE of gadoxetic acid may improve pre-hepatectomy risk assessment.

Systematic review: outcomes and post-operative complications following colectomy for ulcerative colitis.

BACKGROUND: Colectomy for ulcerative colitis is associated with short- and long-term complications. Estimates of the frequency of such complications are variable and may have changed since the introduction of biological therapy. Understanding the true burden of surgical complications is important to clinicians in assessing risks and benefits of colectomy vs. continued medical therapy. AIM: To ascertain the outcomes of colectomy and ileal pouch surgery in patients with ulcerative colitis in the biologics era. METHODS: Embase, MEDLINE and The Cochrane Library were searched for studies (2002-2015) reporting the outcomes of colorectal procedures (total and subtotal colectomy, IPAA with J-, S-, W-pouch) in adults with ulcerative colitis. Conferences proceedings (2011-2015) were hand-searched. RESULTS: We identified 28 studies (20,801 patients) reporting outcomes from procedures conducted from 2002-2015. Early complications (≤30 days post-operatively), reported in 10 studies, occurred in 9-65% of patients with ulcerative colitis; late complications (>30 days post-operatively) occurred in 17-55% of patients. Most frequent short-term complications: infectious complications and ileus (mean incidence 20% and 18%). Most frequent long-term complications: pouchitis, faecal incontinence and small bowel obstruction (mean incidence 29%, 21% and 17%). Rates of early infection and late pouch failure decreased from 22% and 13% in 2002-2009 to 11% and 2% in 2010-2015. The mean incidence of post-operative mortality was 1.0% across 11 studies. CONCLUSIONS: Early and late complications arise in about one-third of patients undergoing surgery for ulcerative colitis. While colorectal surgical procedures are recommended for a specific group of patients, the post-operative complications associated with these procedures should not be underestimated.

Abdominal tuberculosis in a low prevalence country.

OBJECTIVE: Abdominal tuberculosis is a rare disease. The clinical and radiological manifestations are non-specific and the diagnosis is difficult. Our objective was to describe the characteristics and treatment of patients presenting with abdominal tuberculosis in a low-incidence country. PATIENTS AND METHODS: We reviewed the clinical, diagnostic, treatment, and outcome features of patients presenting with abdominal tuberculosis diagnosed by bacteriological and/or histological results and managed in five French university hospitals from January 2000 to December 2009. RESULTS: We included 21 patients. The mean diagnostic delay was 13 months. Twelve patients (57%) came from a low-incidence area and only two had a known immunosuppressed condition. Eighteen patients (86%) presented with abdominal symptoms. The main organs involved were the peritoneum (n=14, 66%), the mesenteric lymph nodes (n=13, 62%), and the bowel (n=7, 33%). Sixteen patients (76%) underwent surgery, including two in an emergency setting. Seventeen patients (81%) received six months or more of anti-tuberculosis treatment. Finally, 16 patients (76%) had a positive outcome. CONCLUSION: New diagnostic procedures, and especially molecular biology, may help diagnose unusual clinical presentations of tuberculosis. Invasive procedures are frequently necessary to obtain samples but also for the treatment of digestive involvement.

Second-stage robot-assisted biliopancreatic diversion with duodenal switch after sleeve gastrectomy.

Biliopancreatic diversion (BPD) was initially described in 1979 and consisted of a distal gastrectomy with a 250-mL stomach pouch and a distal intestinal bypass with a 50 to 100-cm common channel resulting in malabsorption of dietary fat (Scopinaro et al. Br J Surg. 66(9):618-20, 1979). Later, several modifications (sleeve gastrectomy, pylorus preservation, and duodenal switch) were proposed to improve incidence of postoperative dumping syndrome, diarrhea, and anastomotic ulcerations (Lagacé et al. Obes Surg. 5(4):411-8, 1995). Gagner et al. developed a simplified and reproducible approach for laparoscopic BPD with duodenal switch (BPD-DS) after sleeve gastrectomy (Ren et al. Obes Surg. 10(6): 514-23, 2000). BPD-DS has been considered as one of the most difficult bariatric procedures for its surgical complexity and postoperative metabolic complications management. In this regard, the number of BPD-DS has remained extremely low (<4 %). We hypothesize that robotic approach could facilitate the feasibility of BPD-DS procedure. In this multimedia video (8 min), we present a step-by-step robotic BPD-DS.

Risk Factors for Postoperative Morbidity After Totally Robotic Gastric Bypass in 302 Consecutive Patients.

BACKGROUND: Totally robotic gastric bypass (robotic Roux-en-Y gastric bypass, R-RYGBP) has been adopted in some centers on the basis of large retrospective studies. In view of some data showing higher morbidity and higher costs, some authors have considered that robotic gastric bypass may no longer be justified with the existing system. Although low postoperative complication rates after R-RYGBP have been reported, risk factors for postoperative morbidity have never been evaluated. The goal of this study was to identify risk factors for postoperative morbidity after R-RYGBP. METHODS: A retrospective analysis of a prospectively maintained database was performed and included 302 consecutive patients after R-RYGBP performed between 2007 and 2013. This subset of patients represented 34 % of all gastric bypass procedures performed during this study period. Univariate and multivariate analyses were performed in order to identify risk factors for postoperative overall morbidity (Clavien scores 1-4 versus 0) and major morbidity (Clavien score ≥3 versus 0-1-2). RESULTS: Postoperative morbidity and mortality rates were 24.4 and 0.6 %, respectively. In multivariate analysis, independent risk factors for overall morbidity were American Society of Anesthesiologists (ASA) score ≥3 (odds ratio (OR) 2.0) and previous bariatric surgery (revisional gastric bypass) (OR 2.0). Independent risk factors for major morbidity (Clavien ≥3) were previous bariatric surgery (revisional gastric bypass) (OR 3.7), low preoperative hematocrit level (OR 0.9), and revisional gastric bypass procedure with concomitant gastric banding removal (OR 5.7). CONCLUSIONS: R-RYGBP is prone to increased complications in the setting of a high preoperative ASA score and revisional surgery. This should be taken into consideration by clinicians when evaluating R-RYGBP.

Long-term outcome of robotic-assisted laparoscopic rectopexy for full-thickness rectal prolapse in elderly patients.

AIM: Full-thickness rectal prolapse is common in the elderly, but there are no particular practice guidelines for its surgical management. We evaluated retrospectively the perioperative and long-term clinical results and function in elderly and younger patients with complete rectal prolapse after robotic-assisted laparoscopic rectopexy (RALR). METHOD: Seventy-seven patients who underwent RALR between 2002 and 2010 were divided into Group A (age < 75 years, n = 59) and Group B (age > 75 years, n = 18). Operative time, intra- and postoperative complications, length of hospital stay, short-term and long-term outcomes, recurrence rate and degree of satisfaction were evaluated. RESULTS: There was no significant difference between the groups regarding operation time, conversion, morbidity or length of hospital stay. At a median follow-up of 51.8 (5-115) months, there was no difference in the improvement of faecal incontinence, recurrence and the degree of satisfaction. CONCLUSION: Robotic-assisted laparoscopic rectopexy is safe in patients aged over 75 years and gives similar results to those in patients aged < 75 years.