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Background: Primary perineal wound closure after conventional abdominoperineal resection (cAPR) for rectal cancer has been the standard of care for many years. Since the introduction of neo-adjuvant radiotherapy and the extralevator APR (eAPR), oncological outcome has been improved, but at the cost of increased rates of perineal wound healing problems and perineal hernia. This has progressively increased the use of biological meshes, although not supported by sufficient evidence. The aim of this study is to determine the effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo) radiotherapy compared to primary perineal wound closure. Methods/Design: In this multicentre randomized controlled trial, patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo) radiotherapy will be considered eligible. Exclusion criteria are prior radiotherapy, sacral resection above S4/S5, allergy to pig products or polysorbate, collagen disorders, and severe systemic diseases affecting wound healing, except for diabetes. After informed consent, 104 patients will be randomized between standard care using primary wound closure of the perineum and the experimental arm consisting of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm. Patients will be followed for one year after the intervention and outcome assessors and patients will be blinded for the study treatment. The primary endpoint is the percentage of uncomplicated perineal wound healing, defined as a Southampton wound score of less than II on day 30. Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs. Discussion: The BIOPEX-study is the first randomized controlled multicentre study to determine the additive value of using a biological mesh for perineal wound closure after eAPR with neo-adjuvant radiotherapy compared to primary perineal wound closure with regard to perineal wound healing and the occurrence of perineal hernia

Perioperative strategy in colonic surgery; LAparoscopy and/or FAst track multimodal management versus standard care (LAFA trial)

BACKGROUND: Recent developments in large bowel surgery are the introduction of laparoscopic surgery and the implementation of multimodal fast track recovery programs. Both focus on a faster recovery and shorter hospital stay. The randomized controlled multicenter LAFA-trial (LAparoscopy and/or FAst track multimodal management versus standard care) was conceived to determine whether laparoscopic surgery, fast track perioperative care or a combination of both is to be preferred over open surgery with standard care in patients having segmental colectomy for malignant disease. METHODS/DESIGN: The LAFA-trial is a double blinded, multicenter trial with a 2 × 2 balanced factorial design. Patients eligible for segmental colectomy for malignant colorectal disease i.e. right and left colectomy and anterior resection will be randomized to either open or laparoscopic colectomy, and to either standard care or the fast track program. This factorial design produces four treatment groups; open colectomy with standard care (a), open colectomy with fast track program (b), laparoscopic colectomy with standard care (c), and laparoscopic surgery with fast track program (d). Primary outcome parameter is postoperative hospital length of stay including readmission within 30 days. Secondary outcome parameters are quality of life two and four weeks after surgery, overall hospital costs, morbidity, patient satisfaction and readmission rate. Based on a mean postoperative hospital stay of 9 +/- 2.5 days a group size of 400 patients (100 each arm) can reliably detect a minimum difference of 1 day between the four arms (alfa = 0.95, beta = 0.8). With 100 patients in each arm a difference of 10% in subscales of the Short Form 36 (SF-36) questionnaire and social functioning can be detected. DISCUSSION: The LAFA-trial is a randomized controlled multicenter trial that will provide evidence on the merits of fast track perioperative care and laparoscopic colorectal surgery in patients having segmental colectomy for malignant disease

A multicenter randomized clinical trial investigating the cost-effectiveness of treatment strategies with or without antibiotics for uncomplicated acute diverticulitis (DIABOLO trial)

Background. Conservative treatment of uncomplicated or mild diverticulitis usually includes antibiotic therapy. It is, however, uncertain whether patients with acute diverticulitis indeed benefit from antibiotics. In most guidelines issued by professional organizations antibiotics are considered mandatory in the treatment of mild diverticulitis. This advice lacks evidence and is merely based on experts' opinion. Adverse effects of the use of antibiotics are well known, including allergic reactions, development of bacterial resistance to antibiotics and other side-effects. Methods. A randomized multicenter pragmatic clinical trial comparin

The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitisA and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitisB in perforated diverticulitis (NTR2037)

Background: Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy. The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis). Methods/Design: In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVA-arm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVA-arm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and powe

A Systematic Review of Pericolic Extraluminal Air in Left-Sided Acute Colonic Diverticulitis

Background: Although approximately 15% of all patients with acute colonic diverticulitis have pericolic extraluminal air found on computed tomography (CT), studies on the natural course and treatment of these patients are scarce. It is not clear whether these patients behave as mild uncomplicated diverticulitis or as severe diverticulitis needing more aggressive treatment. Consequently, there is no consensus about the treatment, guidelines do not discuss this group of patients, and physicians treat these patients based on their own experiences and opinion. An evidence-based approach is needed to prevent overtreatment or undertreatment in patients with pericolic extraluminal air. Methods: PubMed and EMBASE databases were searched for all studies reporting clinical outcomes of the initial diverticulitis episode of CT-proven left-sided colonic diverticulitis. Primary outcome measures were the need for emergency surgery and percutaneous abscess drainage. Results: A total of eight studies with 251 patients with pericolic extraluminal air were included. Rates of emergency surgery in isolated patients with pericolic extraluminal air were reported in six studies, yielding a pooled rate of 6% (95% confidence interval [CI] 3%-12%). In three studies reporting a combined total of only 56 patients, no patient underwent percutaneous abscess drainage. The long-term (6 mo) need for surgery was 38% in one study, although reasons for surgery were lacking. Conclusion: An initial 94% success rate of non-operative treatment in left-sided colonic diverticulitis patients with pericolic extraluminal air seems to justify a conservative approach including antibiotic agents. Low-quality evidence indicates the need for surgery in up to 38% in the medium-long term

Endoloops or endostapler use in laparoscopic appendectomy for acute uncomplicated and complicated appendicitis : No difference in infectious complications

The most appropriate closure for the appendicular stump with either endoloops or an endostapler in laparoscopic appendectomy remains unclear and under debate because of limited and conflicting evidence. In a 2-month prospective, observational, resident-led nationwide cohort study, patients undergoing laparoscopic appendectomy for both uncomplicated and complicated appendicitis were analysed. Logistic regression analyses were performed for identifying the possible effect of stump closure type and other risk factors for infectious complications. Laparoscopic appendectomy for acute appendicitis was performed in 1369 patients in 62 hospitals; endoloops were used in 76.7 % and an endostapler in other patients. Median operating time was not different between endoloop and endostapler use (42.0 vs. 44.0 min, P = 0.243). A superficial surgical site infection was seen in 2.0 % after uncomplicated appendicitis and in 0.8 % after complicated appendicitis. The intra-abdominal abscess rate was 1.9 % after uncomplicated and 11.0 % after complicated appendicitis. No significant effect of stump closure type was observed for any infectious complication (OR 1.05; 95 % CI 0.625-1.766, P = 0.853) or an intra-abdominal abscess (OR OR 0.96; 95 % CI 0.523-1.768, P = 0.899). In multivariable analysis, complicated appendicitis was identified as the only independent risk factor for an intra-abdominal abscess (OR 6.26; 95 % CI 3.454-11.341, P < 0.001). The infectious complication rate is not influenced by the type of appendicular stump closure with either endoloops or an endostapler in this study. If technically feasible, closure with endoloops is advised for cost consideration

Antibiotic Duration After Laparoscopic Appendectomy for Acute Complicated Appendicitis

Optimal duration of antibiotic treatment to reduce infectious complications after an appendectomy for acute complicated appendicitis remains unclear. To investigate the effect of antibiotic duration on infectious complications after laparoscopic appendectomy for acute complicated appendicitis. National multicenter prospective, observational, surgical resident-led cohort study conducted in June and July 2014. This study involved academic teaching hospitals (n = 8), community teaching hospitals (n = 38), and community nonteaching hospitals (n = 16), and all consecutive patients (n = 1975) who underwent surgery for suspected acute appendicitis. Patients treated laparoscopically for whom the antibiotic regimens were prolonged postoperatively because of complicated appendicitis. Receiving either 3 or 5 days of antibiotic treatment as planned and additional variables were explored as risk factors for infectious complications using regression analyses. A total of 1975 patients were included in 62 participating Dutch hospitals; 1901 (96.3%) of these underwent an appendectomy for acute appendicitis and laparoscopy was used in 74.4% of these patients (n = 1415). In 415 laparoscopically treated patients, antibiotic treatment was continued for more than 24 hours because of acute complicated appendicitis (29.3%). The prescribed antibiotic duration varied between 2 and 6 days in all of these patients. In 123 patients (29.6%), the length of treatment was adjusted. A shorter duration of antibiotic treatment (3 days instead of 5) had no significant effect on any infectious complication (odds ratio [OR], 0.93; 95% CI, 0.38-2.32; P = .88) or on intra-abdominal abscess development (OR, 0.89; 95% CI, 0.34-2.35; P = .81). Perforation of the appendix was the only independent risk factor for the development of an infectious complication (OR, 4.90; 95% CI, 1.41-17.06; P = .01) and intra-abdominal abscess (OR, 7.46; 95% CI, 1.65-33.66; P = .009) in multivariable regression analysis. Lengthening of postoperative antibiotic treatment to 5 days was not associated with a reduction in infectious complications. Further restriction of antibiotic treatment can be considered in nonperforated complicated appendiciti

Complicated Disease Course in Initially Computed Tomography-Proven Uncomplicated Acute Diverticulitis

Background: Although uncomplicated acute diverticulitis has a benign disease course, some patients are at increased risk for complications. Identification of these patients may aid the selection of treatment strategies such as outpatient treatment. This study aimed to assess the rate and timing of a complicated disease course in initially computed tomography (CT)-proven uncomplicated diverticulitis, and to identify risk factors for the development of these diverticular complications. Patients and Methods: Computed tomography-proven, left-sided uncomplicated diverticulitis patients from two cohorts were included. Main outcome measure was complicated diverticulitis (perforation, abscess, obstruction, or fistula) within three months after presentation. Risk factors for diverticular complications were identified using multivariable logistic regression. Results: Of the 1,087 patients with initially CT-proven uncomplicated diverticulitis, 4.9% (53/1,087) developed complicated diverticulitis. Most perforations and abscesses (16/21) occurred during the first 10 days, whereas colonic obstruction and fistula occurred during three months of follow-up. Independent risk factors for the transition from uncomplicated to complicated diverticulitis were American Society of Anesthesiologists (ASA) classification 3/4 (odds ratio [OR] 4.43, 95% confidence interval [CI] 1.57-12.48), duration of symptoms before presentation longer than five days (OR 3.25, 95% CI 1.72-6.13), vomiting (OR 3.94, 95% CI 1.96-7.92), and C-reactive protein (CRP) above 140 mg/L (OR 2.86, 95% CI 1.51-5.43). Conclusion: Approximately one in 20 patients with CT-proven uncomplicated diverticulitis develops a complicated disease course within three months; perforation and abscess occur predominantly within 10 days after presentation. Patients with systemic comorbidity, symptoms for more than five days, those who vomit, or have high CRP levels at presentation are at risk for diverticular complications after an uncomplicated initial presentation and may warrant closer observation

Outcome After Redo Surgery for Complicated Colorectal and Coloanal Anastomosis: A Systematic Review

BACKGROUND: When a colorectal or coloanal anastomosis fails because of persistent leakage or stenosis, or the anastomosis has to be resected for recurrent cancer, constructing a new anastomosis might be an option in selected patients. This is a rare and complex type of redo surgery

Perineal wound healing after abdominoperineal resection for rectal cancer: a two-centre experience in the era of intensified oncological treatment

Intensified treatment for distal rectal cancer has improved oncological outcome, but at the expense of more perineal wound complications in patients undergoing an abdominoperineal resection (APR). The aim of this study was to analyse perineal wound healing after APR with primary perineal wound closure over time. All patients undergoing APR for primary rectal cancer with primary wound closure between 2000 and 2013 were included and analysed in three consecutive time periods. Both early ( <30 days postoperatively) and late perineal wound complications were determined. Independent risk factors of early perineal wound complications were identified using multivariable analysis. A total of 136 patients were identified, of whom 129 patients underwent primary perineal wound closure. The use of neo-adjuvant (chemo)radiotherapy increased from 72 to 91%, and the use of an extralevator approach increased from 9 to 19%. The rate of early perineal wound complications increased from 18 to 31% and was independently associated with an extralevator approach [odds ratio (OR) 3.17; 95% confidence interval (CI) 1.16-8.66] and intra-operative perforation (OR 3.35; 95% CI 1.06-10.57). Perineal wound complications had no impact on local recurrence or 3-year overall survival rate. During a median follow-up of 28 months [interquartile range (IQR) 14-56], a persistent presacral sinus was diagnosed in 10%, and a perineal hernia occurred in 8% of the patients. The increased use of an extralevator APR for rectal cancer significantly increased the risk of perineal wound complications over time. Intra-operative perforation was also independently associated with impaired perineal wound healin