Synthetic Versus Biological Mesh in Laparoscopic and Open Ventral Hernia Repair (LAPSIS): Results of a Multinational, Randomized, Controlled, and Double-blind Trial.

OBJECTIVE: The aim of this study was to investigate the approach (open or laparoscopic) and mesh type (synthetic or biological) in ventral hernias in a clean setting.Summary of Background Data: The level of evidence on the optimal surgical approach and type of mesh in ventral hernia repair is still low. METHODS: Patients with a ventral abdominal hernia (diameter 4-10 cm) were included in this double-blind randomized controlled trial across 17 hospitals in 10 European countries. According to a 2 × 2-factorial design, patients were allocated to 4 arms (open retromuscular or laparoscopic intraperitoneal, with synthetic or Surgisis Gold biological mesh). Patients and outcome assessors were blinded to mesh type used. Major postoperative complication rate (hernia recurrence, mesh infection, or reoperation) within 3 years after surgery, was the primary endpoint in the intention-to-treat population. RESULTS: Between September 1st, 2005, and August 7th, 2009, 253 patients were randomized and 13 excluded. Six of 61 patients (9.8%) in the open synthetic mesh arm, 15 of 66 patients (22.7%) in the open biological mesh arm, 7 of 64 patients (10.9%) in the laparoscopic synthetic mesh arm and 17 of 62 patients (27.4%) in the laparoscopic biological mesh arm had a major complication. The use of biological mesh resulted in significantly more complications (P = 0.013), also after adjusting for hernia type, body mass index, and study site. The trial was prematurely stopped due to an unacceptable high recurrence rate in the biological mesh arms. CONCLUSIONS: The use of Surgisis Gold biological mesh is not recommended for noncomplex ventral hernia repair. TRIAL REGISTRATION: This trial was registered at controlled-trials.com (ISRCTN34532248).

Laparoscopic versus open surgery for suspected appendicitis.

BACKGROUND: The removal of the acute appendix is one of the most frequently performed surgical procedures. Open surgery associated with therapeutic efficacy has been the treatment of choice for acute appendicitis. However, in consequence of the evolution of endoscopic surgery, the operation can also be performed with minimally invasive surgery. Due to smaller incisions, the laparoscopic approach may be associated with reduced postoperative pain, reduced wound infection rate, and shorter time until return to normal activity.This is an update of the review published in 2010. OBJECTIVES: To compare the effects of laparoscopic appendectomy (LA) and open appendectomy (OA) with regard to benefits and harms. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE and Embase (9 February 2018). We identified proposed and ongoing studies from World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov and EU Clinical Trials Register (9 February 2018). We handsearched reference lists of identified studies and the congress proceedings of endoscopic surgical societies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing LA versus OA in adults or children. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed the risk of bias, and extracted data. We performed the meta-analyses using Review Manager 5. We calculated the Peto odds ratio (OR) for very rare outcomes, and the mean difference (MD) for continuous outcomes (or standardised mean differences (SMD) if researchers used different scales such as quality of life) with 95% confidence intervals (CI). We used GRADE to rate the quality of the evidence. MAIN RESULTS: We identified 85 studies involving 9765 participants. Seventy-five trials included 8520 adults and 10 trials included 1245 children. Most studies had risk of bias issues, with attrition bias being the largest source across studies due to incomplete outcome data.In adults, pain intensity on day one was reduced by 0.75 cm on a 10 cm VAS after LA (MD -0.75, 95% CI -1.04 to -0.45; 20 RCTs; 2421 participants; low-quality evidence). Wound infections were less likely after LA (Peto OR 0.42, 95% CI 0.35 to 0.51; 63 RCTs; 7612 participants; moderate-quality evidence), but the incidence of intra-abdominal abscesses was increased following LA (Peto OR 1.65, 95% CI 1.12 to 2.43; 53 RCTs; 6677 participants; moderate-quality evidence).The length of hospital stay was shortened by one day after LA (MD -0.96, 95% CI -1.23 to -0.70; 46 RCTs; 5127 participant; low-quality evidence). The time until return to normal activity occurred five days earlier after LA than after OA (MD -4.97, 95% CI -6.77 to -3.16; 17 RCTs; 1653 participants; low-quality evidence). Two studies showed better quality of life scores following LA, but used different scales, and therefore no pooled estimates were presented. One used the SF-36 questionnaire two weeks after surgery and the other used the Gastro-intestinal Quality of Life Index six weeks and six months after surgery (both low-quality evidence).In children, we found no differences in pain intensity on day one (MD -0.80, 95% CI -1.65 to 0.05; 1 RCT; 61 participants; low-quality evidence), intra-abdominal abscesses after LA (Peto OR 0.54, 95% CI 0.24 to 1.22; 9 RCTs; 1185 participants; low-quality evidence) or time until return to normal activity (MD -0.50, 95% CI -1.30 to 0.30; 1 RCT; 383 participants; moderate-quality evidence). However, wound infections were less likely after LA (Peto OR 0.25, 95% CI 0.15 to 0.42; 10 RCTs; 1245 participants; moderate-quality evidence) and the length of hospital stay was shortened by 0.8 days after LA (MD -0.81, 95% CI -1.01 to -0.62; 6 RCTs; 316 participants; low-quality evidence). Quality of life was not reported in any of the included studies. AUTHORS' CONCLUSIONS: Except for a higher rate of intra-abdominal abscesses after LA in adults, LA showed advantages over OA in pain intensity on day one, wound infections, length of hospital stay and time until return to normal activity in adults. In contrast, LA showed advantages over OA in wound infections and length of hospital stay in children. Two studies reported better quality of life scores in adults. No study reported this outcome in children. However, the quality of evidence ranged from very low to moderate and some of the clinical effects of LA were small and of limited clinical relevance. Future studies with low risk of bias should investigate, in particular, the quality of life in children.

ARTHROSCOPIC SURGERY FOR KNEE OSTEOARTHRITIS: IMPACT OF HEALTH TECHNOLOGY ASSESSMENT IN GERMANY.

OBJECTIVES: This study aims to describe how a negative reimbursement decision-based on the health technology assessment (HTA) report of a nondrug intervention-affects healthcare providers in Germany. METHODS: Knee arthroscopy was chosen as an example, because as of April 2016 this procedure is no longer reimbursed for osteoarthritis, but is still covered for other indications, including meniscal lesions. The exclusion followed an HTA report prepared by the Institute for Quality and Efficiency in Health Care (IQWiG). Here, we examine how the decision to revoke reimbursement for arthroscopy was perceived by the surgical community. Information was collected from official hospital statistics, the internet, and informal interviews with orthopedic surgeons. RESULTS: In 2015, a total of 37,920 arthroscopic procedures were performed for knee osteoarthritis in Germany. Several surgical societies were unhappy with the negative decision, which was issued as a directive in November 2015, and they challenged the decision-making process as well as the underlying scientific evidence. In March 2016, fifteen societies issued joint recommendations on how to differentiate osteoarthritis from other knee diseases and how to document other diseases in a way that inspections by representatives of health insurance funds would not detect any deficiencies. In informal interviews, orthopedic surgeons indicated that miscoding of the principal diagnosis (meniscal tear rather than knee osteoarthritis) is to be expected, especially in the hospital sector. CONCLUSIONS: HTA can have a significant impact on the provision of health services, but various loopholes allow physicians to undermine policy decisions. Therefore, it is important to involve all stakeholders in HTA and to convince them of the benefits of evidence-based medicine.

Single-incision versus standard multi-incision laparoscopic colectomy in patients with malignant or benign colonic disease: a systematic review, meta-analysis and assessment of the evidence.

BACKGROUND: Single-incision laparoscopic colectomy (SILC) requires only one umbilical port site and (depending on technique) a specimen extraction site. The aim of this study was the assessment of the available evidence for the comparison of SILC to conventional multi-port laparoscopic colectomy (MLC) in adult patients, in whom elective colectomy is indicated because of malignant or benign disease. First, previous meta-analyses on this topic were assessed. Secondly, a systematic review and meta-analysis of randomised controlled trials, was performed. METHODS: Electronic literature searches (CENTRAL, MEDLINE and EMBASE; up to March 2016) were performed. Additionally, we searched clinical trials registries and abstracts from surgical society meetings. For meta-analysis, risk ratios (RR) or mean differences (MD) with 95 % confidence intervals were calculated and pooled. The quality of previous meta-analyses was evaluated against established criteria (AMSTAR) and their reported results were investigated for consistency. RESULTS: We identified 6 previous meta-analyses of mostly low methodological quality (AMSTAR total score: 2 - 5 out of 11 items). To fill the evidence gaps, all these meta-analyses had included non-randomised studies, but usually without assessing their risk of bias. In our systematic review and meta-analysis of randomised controlled trials exclusively, we included two randomised controlled trials with a total of 82 colorectal cancer patients. There was insufficient evidence to clarify whether SILC leads to less local complications (RR = 0.52, 95 % CI 0.14 - 1.94) or lower mortality (1 death per treatment group). Length of hospital stay was significantly shorter in the SILC group (MD = -1.20 days, 95 % CI -1.95 to -0.44). One of the two studies found postoperative pain intensity to be lower at the first day. We also identified 7 ongoing trials with a total sample size of over 1000 patients. CONCLUSION: The currently available study results are too sparse to detect (or rule out) relevant differences between SILC and MLC. The quality of the current evidence is low, and the additional analysis of non-randomised data attempts, but does not solve this problem. SILC should still be considered as an experimental procedure, since the evidence of well-designed randomised controlled trials is too sparse to allow any recommendation.

Tamponade dressings may be unnecessary after haemorrhoidectomy: a randomised controlled clinical trial.

PURPOSE: Bleeding after haemorrhoidectomy is common. Many surgical textbooks recommend insertion of an anal tampon in order to reduce postoperative bleeding. This practice, however, is bothersome and probably painful for patients. The effect of using a tamponade has not been validated in randomised controlled trials. METHODS: The study included 100 patients who were scheduled for Milligan-Morgan haemorrhoidectomy. During surgery, patients were randomly assigned to receive or not to receive an anal tampon at the end of the procedure. Data on pain, complications and wound care were collected. The trial was registered (DRKS00003116) and all analyses were by intention-to-treat. RESULTS: There were 48 patients in the group with tamponade, and 52 patients were left without tamponade. The trial's primary outcome and maximum pain intensity, averaged 6.1 and 4.2 in the two groups (P = 0.001). In the group with tamponade, a complication was recorded in seven patients (15 %), which was similar to the group without tamponade (21 %). Severe anal bleeding occurred in two and five patients, respectively. Bandage changes were less necessary often in the group treated without tamponade (P = 0.013). Hospital stay was 4 days in both groups. CONCLUSIONS: Data indicate that insertion of an anal tampon after haemorrhoidectomy does not reduce postoperative bleeding but causes significantly more pain. After haemorrhoidectomy, anal tampons should not be used routinely but may be considered when specific indications justify its use.

Approaches to assessing the benefits and harms of medical devices for application in surgery.

BACKGROUND: The surgical community and the medical device industry enjoy a fruitful cooperation for the benefit of patients, but during the last years several high-risk products have led to problems and scandals, thus highlighting the need for reforms in European CE marking requirements. In October 2013, the European Parliament voted on a draft regulation on medical devices that intends to replace the current directives in 2014. PURPOSE: This article offers guidance to surgeons on how to select and assess medical devices for clinical use. Examples include artificial sphincters, surgical meshes, as well as single-incision and robot-assisted surgery. It is important that surgeons have a basic understanding of the requirements for CE marking of new medical devices. Because device performance rather than effectiveness is required for European market entry, surgeons (and their patients) are often left with the burden of using potentially harmful devices. In addition, potential problems concerning the safety or effectiveness of approved devices are concealed by the lack of data transparency. Because regulatory reforms were blocked at the European level, many member states will now seek other ways of restricting the use of medical devices with unknown effectiveness. One interesting model in this regard is to link the reimbursement of new medical devices to the conduct of clinical trials. CONCLUSIONS: Surgeons should develop a structured multidisciplinary approach to innovation management in their hospitals before using a new high-risk device. The key question is how to strike the right balance between innovation and safety.

Efficacy and safety of sclerotherapy with polidocanol foam in comparison with fluid sclerosant in the treatment of first-grade haemorrhoidal disease: a randomised, controlled, single-blind, multicentre trial.

PURPOSE: Sclerotherapy is the treatment of choice for first-grade haemorrhoidal disease. Numerous studies have shown that sclerotherapy with foamed sclerosants is more efficacious than liquid in the treatment of varicose veins. The aim of this study was to assess the efficacy and safety of polidocanol foam in comparison with liquid for haemorrhoidal disease. METHODS: A total of 130 patients were randomised to foam or liquid sclerotherapy (polidocanol 3%). Patients with first-grade haemorrhoidal disease were included and blinded to treatment assignment. The primary endpoint was the stopping of perianal bleeding after one sclerotherapy session. Sclerotherapy was repeated until patients were free of bleeding (2-week intervals). The final follow-up was 12 weeks after the last sclerotherapy session. RESULTS: In the foam group, significantly more patients (88%) were treated successfully after one sclerotherapy session compared to the liquid group (69%; p = 0.01). There was high patient satisfaction in both groups, but significantly more patients were satisfied with their treatment in the foam group than in the liquid group (99 vs. 84%; p = 0.009). Additionally, in the foam group, significantly less treatment sessions were required (p < 0.001), and the total amount of injected polidocanol was reduced (p < 0.001). CONCLUSION: In the therapy of first-grade haemorrhoidal disease, polidocanol 3 % foam is more effective and equally safe compared to liquid polidocanol. The results of this trial show that foam sclerotherapy is a new, innovative, effective and safe non-surgical treatment option for haemorrhoidal disease.

Multimedia-based training on Internet platforms improves surgical performance: a randomized controlled trial.

BACKGROUND: Surgical procedures are complex motion sequences that require a high level of preparation, training, and concentration. In recent years, Internet platforms providing surgical content have been established. Used as a surgical training method, the effect of multimedia-based training on practical surgical skills has not yet been evaluated. This study aimed to evaluate the effect of multimedia-based training on surgical performance. METHODS: A 2 × 2 factorial, randomized controlled trial with a pre- and posttest design was used to test the effect of multimedia-based training in addition to or without practical training on 70 participants in four groups defined by the intervention used: multimedia-based training, practical training, and combination training (multimedia-based training + practical training) or no training (control group). The pre- and posttest consisted of a laparoscopic cholecystectomy in a Pelvi-Trainer and was video recorded, encoded, and saved on DVDs. These were evaluated by blinded raters using a modified objective structured assessment of technical skills (OSATS). The main evaluation criterion was the difference in OSATS score between the pre- and posttest (ΔOSATS) results in terms of a task-specific checklist (procedural steps scored as correct or incorrect). RESULTS: The groups were homogeneous in terms of demographic parameters, surgical experience, and pretest OSATS scores. The ΔOSATS results were highest in the multimedia-based training group (4.7 ± 3.3; p < 0.001). The practical training group achieved 2.5 ± 4.3 (p = 0.028), whereas the combination training group achieved 4.6 ± 3.5 (p < 0.001), and the control group achieved 0.8 ± 2.9 (p = 0.294). CONCLUSION: Multimedia-based training improved surgical performance significantly and thus could be considered a reasonable tool for inclusion in surgical curricula.

Pre-market clinical evaluations of innovative high-risk medical devices in Europe.

OBJECTIVES: High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. METHODS: The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information. RESULTS: In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. CONCLUSIONS: For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.

Evidence-based German guidelines for surgery for obesity.

BACKGROUND: The young field of obesity surgery (bariatric surgery) in Germany expands as a consequence of the rapid increase of overweight and obesity. New surgical methods, minimal access techniques, and the enormous increase of scientific studies and evidence, all contribute to the success of bariatric surgery, which is the only realistic chance of permanent weight loss and regression of secondary diseases in many cases. METHODS: A systematic literature review, classification of evidence, graded recommendations, and interdisciplinary consensus. RESULTS: Obesity surgery is an integral component of the multimodal treatment of obesity, which consists of multidisciplinary evaluation and preparation, conservative and surgical treatment elements, and a life-long follow-up. The guideline confirms the body mass index (BMI)-based spectrum of indications (BMI > 40 kg/m(2) or >35 kg/m(2) with secondary diseases) and extends it through elimination of all age restrictions (>18 years and <60 years) and most of the contraindications. Precondition for surgery is the failure of a structured conservative program of 6-12 months or the expected futility of it. Type II diabetes mellitus becomes an independent indication criterion for BMI < 35 kg/m(2) (metabolic surgery). The standard techniques are gastric balloon, gastric banding, gastric bypass, gastric sleeve, and biliopancreatic diversion. The choice of procedure is based on profound knowledge of results, long-term effects, complications, and patient-specific circumstances. The after-care should be structured and organized long term. CONCLUSION: The S3-guidelines contain evidence-based recommendations for the indication, selection of procedure, technique, and follow-up. Patient care should improve after implementation of these guidelines in clinical practice. Compliance by decision makers and health insurers is warranted.

Laparoscopic versus open surgical techniques for ventral or incisional hernia repair.

BACKGROUND: There are many different techniques currently in use for ventral and incisional hernia repair. Laparoscopic techniques have become more common in recent years, although the evidence is sparse. OBJECTIVES: We compared laparoscopic with open repair in patients with (primary) ventral or incisional hernia. SEARCH STRATEGY: We searched the following electronic databases: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, metaRegister of Controlled Trials. The last searches were conducted in July 2010. In addition, congress abstracts were searched by hand. SELECTION CRITERIA: We selected randomised controlled studies (RCTs), which compared the two techniques in patients with ventral or incisional hernia. Studies were included irrespective of language, publication status, or sample size. We did not include quasi-randomised trials. DATA COLLECTION AND ANALYSIS: Two authors assessed trial quality and extracted data independently. Meta-analytic results are expressed as relative risks (RR) or weighted mean difference (WMD). MAIN RESULTS: We included 10 RCTs with a total number of 880 patients suffering primarily from primary ventral or incisional hernia. No trials were identified on umbilical or parastomal hernia. The recurrence rate was not different between laparoscopic and open surgery (RR 1.22; 95% CI 0.62 to 2.38; I(2) = 0%), but patients were followed up for less than two years in half of the trials. Results on operative time were too heterogeneous to be pooled. The risk of intraoperative enterotomy was slightly higher in laparoscopic hernia repair (Peto OR 2.33; 95% CI 0.53 to 10.35), but this result stems from only 7 cases with bowel lesion (5 vs. 2). The most clear and consistent result was that laparoscopic surgery reduced the risk of wound infection (RR = 0.26; 95% CI 0.15 to 0.46; I(2)= 0%). Laparoscopic surgery shortened hospital stay significantly in 6 out of 9 trials, but again data were heterogeneous. Based on a small number of trials, it was not possible to detect any difference in pain intensity, both in the short- and long-term evaluation. Laparoscopic repair apparently led to much higher in-hospital costs. AUTHORS' CONCLUSIONS: The short-term results of laparoscopic repair in ventral hernia are promising. In spite of the risks of adhesiolysis, the technique is safe. Nevertheless, long-term follow-up is needed in order to elucidate whether laparoscopic repair of ventral/incisional hernia is efficacious.

Low-dose rate brachytherapy for men with localized prostate cancer.

BACKGROUND: Localized prostate cancer is a slow growing tumor for many years for the majority of affected men. Low-dose rate brachytherapy (LDR-BT) is short-distance radiotherapy using low-energy radioactive sources. LDR-BT has been recommended for men with low risk localized prostate cancer. OBJECTIVES: To assess the benefit and harm of LDR-BT compared to radical prostatectomy (RP), external beam radiotherapy (EBRT), and no primary therapy (NPT) in men with localized prostatic cancer. SEARCH STRATEGY: The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (from 1950), and EMBASE (from 1980) were searched in June 2010 as well as online trials registers and reference lists of reviews. SELECTION CRITERIA: Randomized, controlled trials comparing LDR-BT versus RP, EBRT, and NPT in men with clinically localized prostate cancer. DATA COLLECTION AND ANALYSIS: Data on study methods, participants, treatment regimens, observation period and outcomes were recorded by two reviewers independently. MAIN RESULTS: We identified only one RCT (N = 200; mean follow up 68 months). This trial compared LDR-BT and RP. The risk of bias was deemed high. Primary outcomes (overall survival, cause-specific mortality, or metastatic-free survival) were not reported. Biochemical recurrence-free survival at 5 years follow up was not significantly different between LDR-BT (78/85 (91.8%)) and RP (81/89 (91.0%)); P = 0.875; relative risk 0.92 (95% CI: 0.35 to 2.42).For severe adverse events reported at 6 months follow up, results favored LDR-BT for urinary incontinence (LDR-BT 0/85 (0.0%) versus RP 16/89 (18.0%); P < 0.001; relative risk 0) and favored RP for urinary irritation (LDR-BT 68/85 (80.0%) versus RP 4/89 (4.5%); P < 0.001; relative risk 17.80, 95% CI 6.79 to 46.66). The occurrence of urinary stricture did not significantly differ between the treatment groups (LDR-BT 2/85 (2.4%) versus RP 6/89 (6.7%); P = 0.221; relative risk 0.35, 95% CI: 0.07 to 1.68). Long-term information was not available.We did not identify significant differences of mean scores between treatment groups for patient-reported outcomes function and bother as well as generic health-related quality of life. AUTHORS' CONCLUSIONS: Low-dose rate brachytherapy did not reduce biochemical recurrence-free survival versus radical prostatectomy at 5 years. For short-term severe adverse events, low-dose rate brachytherapy was significantly more favorable for urinary incontinence, but radical prostatectomy was significantly more favorable for urinary irritation. Evidence is based on one RCT with high risk of bias.

Peri-operative chemotherapy for the treatment of resectable liver metastases from colorectal cancer: A systematic review and meta-analysis of randomized trials.

BACKGROUND: The role of peri-operative chemotherapy in patients with resected stage IV colorectal cancer (CRC) remains to be defined. This study was aimed at evaluating the effectiveness of peri-operative chemotherapy in patients with resected stage IV CRC by performing a meta-analysis of relevant trials. METHODS: We performed a literature search to identify trials comparing patients with stage IV CRC receiving peri-operative chemotherapy and surgery with patients undergoing surgery alone. The hazard ratio (HR) was estimated to assess any survival advantage of peri-operative chemotherapy. RESULTS: Eight trials conducted on a total of 1174 patients were identified by a literature search. In these trials, HR estimates suggested that peri-operative chemotherapy yielded no survival advantage over surgery alone (HR, 0.94; 95%CI, 0.8-1.10; p = 0.43). In a subset analysis on intra-arterial chemotherapy alone, no survival benefit was evident (HR, 1.0; 95% CI, 0.84-1.21; p = 0.96; I2 = 30%), whereas in the trials involving systemic chemotherapy, the difference between the groups approached statistical significance (HR, 0.74; 95% CI, 0.53-1.04; p = 0.08; I2 = 0%). Both peri-operative treatment groups had a significant recurrence-free survival benefit (HR, 0.78; 95% CI, 0.65-0.95; P = 0.01 for hepatic arterial infusion; and HR, 0.75; 95% CI, 0.62-0.91; p = 0.003 for systemic therapy). The toxicities of chemotherapy were acceptable in most trials. CONCLUSIONS: This is the first meta-analysis demonstrating the importance of peri-operative chemotherapy in the treatment of resected stage IV CRC. Although the results must be carefully interpreted because of some limitations, critical issues were identified that must be resolved by future studies.

Clinical effectiveness of selective granulocyte, monocyte adsorptive apheresis with the Adacolumn device in ulcerative colitis.

The purpose of this meta-analysis was to determine whether selective adsorptive granulocyte and monocyte apheresis (GMA apheresis) using the Adacolumn device can effectively reduce clinical symptoms and endoscopic signs of inflammation in patients with ulcerative colitis (UC). A comprehensive search for randomized controlled trials (RCTs) published up to May 2008 was performed. Each study's quality was evaluated, and the data reported in the results were abstracted. Pooled relative risk (RR) estimates and 95% confidence intervals (CIs) were calculated using the fixed-effects model. Heterogeneity was quantified statistically and explained by the variation in the trial design. Seven RCTs including 594 patients were found, and six RCTs on active UC contributed to the main analyses. In half of the trials, GMA apheresis was compared to steroids. Only one trial was fully blinded. A response or remission after 6 weeks was achieved more often in patients treated with GMA apheresis (RR 1.42; CI 1.15-1.75). Also, after 12 weeks, GMA apheresis produced significantly higher remission rates (RR 1.41; CI 1.08-1.83), but long-term data were sparse. In the trials that compared GMA apheresis and steroids (n = 220 patients), side effects were much less frequent in the GMA apheresis groups (RR 0.19; CI 0.11-0.34). Homogeneous evidence from seven RCTs shows that GMA apheresis induces a clinical remission in a higher proportion of UC patients as compared to conventional medical therapy.

Laparoscopic versus open surgery for suspected appendicitis.

BACKGROUND: Laparoscopic surgery for acute appendicitis has been proposed to have advantages over conventional surgery. OBJECTIVES: To compare the diagnostic and therapeutic effects of laparoscopic and conventional 'open' surgery. SEARCH STRATEGY: We searched the Cochrane Library, MEDLINE, EMBASE, LILACS, CNKI, SciSearch, study registries, and the congress proceedings of endoscopic surgical societies. SELECTION CRITERIA: We included randomized clinical trials comparing laparoscopic (LA) versus open appendectomy (OA) in adults or children. Studies comparing immediate OA versus diagnostic laparoscopy (followed by LA or OA if necessary) were separately identified. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality. Missing information or data was requested from the authors. We used odds ratios (OR), relative risks (RR), and 95% confidence intervals (CI) for analysis. MAIN RESULTS: We included 67 studies, of which 56 compared LA (with or without diagnostic laparoscopy) vs. OA in adults. Wound infections were less likely after LA than after OA (OR 0.43; CI 0.34 to 0.54), but the incidence of intraabdominal abscesses was increased (OR 1.87; CI 1.19 to 2.93). The duration of surgery was 10 minutes (CI 6 to 15) longer for LA. Pain on day 1 after surgery was reduced after LA by 8 mm (CI 5 to 11 mm) on a 100 mm visual analogue scale. Hospital stay was shortened by 1.1 day (CI 0.7 to 1.5). Return to normal activity, work, and sport occurred earlier after LA than after OA. While the operation costs of LA were significantly higher, the costs outside hospital were reduced. Seven studies on children were included, but the results do not seem to be much different when compared to adults. Diagnostic laparoscopy reduced the risk of a negative appendectomy, but this effect was stronger in fertile women (RR 0.20; CI 0.11 to 0.34) as compared to unselected adults (RR 0.37; CI 0.13 to 1.01). AUTHORS' CONCLUSIONS: In those clinical settings where surgical expertise and equipment are available and affordable, diagnostic laparoscopy and LA (either in combination or separately) seem to have various advantages over OA. Some of the clinical effects of LA, however, are small and of limited clinical relevance. In spite of the mediocre quality of the available research data, we would generally recommend to use laparoscopy and LA in patients with suspected appendicitis unless laparoscopy itself is contraindicated or not feasible. Especially young female, obese, and employed patients seem to benefit from LA.

Why so late?!--delay in treatment of colorectal cancer is socially determined.

PURPOSE: The interval between symptom onset and therapy in patients with colorectal cancer was studied. METHODS: One hundred twenty three patients with colorectal cancer were included. Demography data, symptoms, consultations, and tumour stage were obtained by standardized questionnaires. Risk factors for delayed treatment were analysed. RESULTS: Eighty six patients suffered from colonic cancer. The total time between the first symptoms and therapy ranged from 13 to 442 days (mean, 148). Delay of surgical therapy was responsible for significantly higher tumour grades. Delayed start of therapy was found to be correlated to the type of cancer, socioeconomic status, marital status, and quality of first consultation (univariate analysis). On multivariate analyses, type of cancer, marital and socioeconomic status remained significantly associated with delayed treatment (all p values ≤ 0.001, r(2) = 0.50). CONCLUSIONS: The delay in treatment of colorectal cancer depends on socioeconomic status and family background. Achieving equity in colorectal cancer detection may require consideration of high-risk subgroups.

Development and validation of study filters for identifying controlled non-randomized studies in PubMed and Ovid MEDLINE.

A retrospective analysis published by the German Institute for Quality and Efficiency in Health Care (IQWiG) in 2018 concluded that no filter for non-randomized studies (NRS) achieved sufficient sensitivity (≥92%), a precondition for comprehensive information retrieval. New NRS filters are therefore required, taking into account the challenges related to this study type. Our evaluation focused on the development of study filters for NRS with a control group ("controlled NRS"), as this study type allows the calculation of an effect size. In addition, we assumed that due to the more explicit search syntax, controlled NRS are easier to identify than non-controlled ones, potentially resulting in better performance measures of study filters for controlled NRS. Our aim was to develop study filters for identifying controlled NRS in PubMed and Ovid MEDLINE. We developed two new search filters that can assist clinicians and researchers in identifying controlled NRS in PubMed and Ovid MEDLINE. The reference set was based on 2110 publications in Medline extracted from 271 Cochrane reviews and on 4333 irrelevant references. The first filter maximizes sensitivity (92.42%; specificity 79.67%, precision 68.49%) and should be used when a comprehensive search is needed. The second filter maximizes specificity (92.06%; precision 82.98%, sensitivity 80.94%) and should be used when a more focused search is sufficient.