Incisional Hernia Cannot Be Diagnosed by a Patient-Reported Diagnostic Questionnaire.

BACKGROUND: Incisional hernia (IH) is one of the most frequent complications after abdominal surgery. Follow-up with regard to IH remains challenging. Physical examination and imaging to diagnose IH are time-consuming and costly, require devotion of both the physician and patient, and are often not prioritized. Therefore, a patient-reported diagnostic questionnaire for the diagnosis of IH was developed. Objective of this study was to validate this questionnaire in a consecutive sample of patients. METHODS: All patients above 18 y of age who underwent abdominal surgery with a midline incision at least 12 mo ago were eligible for inclusion. Included patients visited the outpatient clinic where they filled out the diagnostic questionnaire and underwent physical examination. The questionnaire answers were compared with the physical examination results. The diagnostic accuracy of the entire questionnaire was assessed by multivariable logistic regression. RESULTS: In total, 241 patients visited the outpatient clinic prospectively. 54 (22%) patients were diagnosed with IH during physical examination. The area under the receiver operating characteristic curve of the diagnostic questionnaire was 0.82. Sensitivity and specificity were respectively 81.5% and 77.5%. The positive and negative predictive values were 51.2% and 94%, respectively. Ten (19%) patients with IH were missed by the questionnaire. CONCLUSIONS: The patient-reported diagnostic questionnaire as currently proposed cannot be used to diagnose IH. However, given the high negative predictive value, the questionnaire might be used to rule out an IH. Long-term follow-up for the diagnosis of IH should be performed by clinical examination.

Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial.

BACKGROUND: Acute appendicitis is one of the most common indications for emergency surgery. In patients with a complex appendicitis, prolonged antibiotic prophylaxis is recommended after appendectomy. There is no consensus regarding the optimum duration of antibiotics. Guidelines propose 3 to 7 days of treatment, but shorter courses may be as effective in the prevention of infectious complications. At the same time, the global issue of increasing antimicrobial resistance urges for optimization of antibiotic strategies. The aim of this study is to determine whether a short course (48 h) of postoperative antibiotics is non-inferior to current standard practice of 5 days. METHODS: Patients of 8 years and older undergoing appendectomy for acute complex appendicitis - defined as a gangrenous and/or perforated appendicitis or appendicitis in presence of an abscess - are eligible for inclusion. Immunocompromised or pregnant patients are excluded, as well as patients with a contraindication to the study antibiotics. In total, 1066 patients will be randomly allocated in a 1:1 ratio to the experimental treatment arm (48 h of postoperative intravenously administered (IV) antibiotics) or the control arm (5 days of postoperative IV antibiotics). After discharge from the hospital, patients participate in a productivity-cost-questionnaire at 4 weeks and a standardized telephone follow-up at 90 days after appendectomy. The primary outcome is a composite endpoint of infectious complications, including intra-abdominal abscess (IAA) and surgical site infection (SSI), and mortality within 90 days after appendectomy. Secondary outcomes include IAA, SSI, restart of antibiotics, length of hospital stay (LOS), reoperation, percutaneous drainage, readmission rate, and cost-effectiveness. The non-inferiority margin for the difference in the primary endpoint rate is set at 7.5% (one-sided test at ɑ 0.025). Both per-protocol and intention-to-treat analyses will be performed. DISCUSSION: This trial will provide evidence on whether 48 h of postoperative antibiotics is non-inferior to a standard course of 5 days of antibiotics. If non-inferiority is established, longer intravenous administration following appendectomy for complex appendicitis can be abandoned, and guidelines need to be adjusted accordingly. TRIAL REGISTRATION: Dutch Trial Register, NTR6128 . Registered on 20 December 2016.

Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement versus primary suture only in midline laparotomies (PRIMA): 2-year follow-up of a multicentre, double-blind, randomised controlled trial.

BACKGROUND: Incisional hernia is a frequent long-term complication after abdominal surgery, with a prevalence greater than 30% in high-risk groups. The aim of the PRIMA trial was to evaluate the effectiveness of mesh reinforcement in high-risk patients, to prevent incisional hernia. METHODS: We did a multicentre, double-blind, randomised controlled trial at 11 hospitals in Austria, Germany, and the Netherlands. We included patients aged 18 years or older who were undergoing elective midline laparotomy and had either an abdominal aortic aneurysm or a body-mass index (BMI) of 27 kg/m2 or higher. We randomly assigned participants using a computer-generated randomisation sequence to one of three treatment groups: primary suture; onlay mesh reinforcement; or sublay mesh reinforcement. The primary endpoint was incidence of incisional hernia during 2 years of follow-up, analysed by intention to treat. Adjusted odds ratios (ORs) were estimated by logistic regression. This trial is registered at ClinicalTrials.gov, number NCT00761475. FINDINGS: Between March, 2009, and December, 2012, 498 patients were enrolled to the study, of whom 18 were excluded before randomisation. Therefore, we included 480 patients in the primary analysis: 107 were assigned primary suture only, 188 were allocated onlay mesh reinforcement, and 185 were assigned sublay mesh reinforcement. 92 patients were identified with an incisional hernia, 33 (30%) who were allocated primary suture only, 25 (13%) who were assigned onlay mesh reinforcement, and 34 (18%) who were assigned sublay mesh reinforcement (onlay mesh reinforcement vs primary suture, OR 0·37, 95% CI 0·20-0·69; p=0·0016; sublay mesh reinforcement vs primary suture, 0·55, 0·30-1·00; p=0·05). Seromas were more frequent in patients allocated onlay mesh reinforcement (34 of 188) than in those assigned primary suture (five of 107; p=0·002) or sublay mesh reinforcement (13 of 185; p=0·002). The incidence of wound infection did not differ between treatment groups (14 of 107 primary suture; 25 of 188 onlay mesh reinforcement; and 19 of 185 sublay mesh reinforcement). INTERPRETATION: A significant reduction in incidence of incisional hernia was achieved with onlay mesh reinforcement compared with sublay mesh reinforcement and primary suture only. Onlay mesh reinforcement has the potential to become the standard treatment for high-risk patients undergoing midline laparotomy. FUNDING: Baxter; B Braun Surgical SA.

A scoring system to predict the severity of appendicitis in children.

BACKGROUND: It appears that two forms of appendicitis exist. Preoperative distinction between the two is essential to optimize treatment outcome. This study aimed to develop a scoring system to accurately determine the severity of appendicitis in children. MATERIALS AND METHODS: Historical cohort study of pediatric patients (aged 0-17 y old) with appendicitis treated between January 2010 and December 2012. Division into simple, complex appendicitis, or another condition based on preset criteria. Multiple logistic regression analysis was used to build the prediction model with subsequent validation. RESULTS: There were 64 patients with simple and 66 with complex appendicitis. Five variables explained 64% of the variation. Independent validation of the derived prediction model in a second cohort (55 simple and 10 complex appendicitis patients) demonstrated 90% sensitivity (54-99), 91% specificity (79-97), a positive predictive value of 64% (36-86), and an negative predictive value of 98% (88-100). The likelihood ratio+ was 10 (4.19-23.42), and likelihood ratio- was 0.11 (0.02-0.71). Diagnostic accuracy was 91% (84-98). CONCLUSIONS: Our scoring system consisting of five variables can be used to exclude complex appendicitis in clinical practice if the score is <4.

Impact of the European Working Time Directive (EWTD) on the operative experience of surgery residents.

BACKGROUND: In Europe and the United States, work hour restrictions are considered to be particularly burdensome for residents in surgery specialties. The aim of this study was to examine whether reduction of the work week to 48 hours resulting from the implementation of the European Working Time Directive has affected the operative experience of surgery residents. METHODS: This study was conducted in a general surgery training region in the Netherlands, consisting of 1 university hospital and 6 district training hospitals. Operating records summarizing the surgical procedures performed as "primary surgeon" in the operating theater for different grades of surgeons were retrospectively analyzed for the period 2005-2012 by the use of linear regression models. Operative procedures performed by residents were considered the main outcome measure. RESULTS: In total, 235,357 operative procedures were performed, including 47,458 (20.2%) in the university hospital and 187,899 (79.8%) in the district training hospitals (n = 5). For residents in the university hospital, the mean number of operative procedures performed per 1.0 full-time equivalent increased from 128 operations in 2005 to 204 operations in 2012 (P = .001), whereas for residents in district training hospitals, no substantial differences were found over time. The mean (±SD) operative caseload of 64 residents who completed the 6-year training program between 2005 and 2012 was 1,391 ± 226 (range, 768-1856). A comparison of the operative caseload according to year of board-certification showed no difference. CONCLUSION: Implementation of the European Working Time Directive has not affected adversely the number of surgical procedures performed by residents within a general surgical training region in the Netherlands.

Short-term results of a randomized controlled trial comparing primary suture with primary glued mesh augmentation to prevent incisional hernia.

BACKGROUND: Incisional hernia is one of the most frequent postoperative complications after abdominal surgery. Patients with an abdominal aortic aneurysm and patients with a body mass index of 27 or higher have an increased risk to develop incisional hernia. Primary mesh augmentation is a method in which the abdominal wall is strengthened to reduce incisional hernia incidence. This study focused on the short-term results of the PRImary Mesh Closure of Abdominal Midline Wounds trial, a multicenter double blind randomized controlled trial. METHODS: Between 2009 and 2012 patients were included if they were operated via midline laparotomy, and had an abdominal aortic aneurysm or a body mass index of 27 or higher. Patients were randomly assigned to either receive primary suture, onlay mesh augmentation (OMA), or sublay mesh augmentation. RESULTS: Outcomes represent results after 1-month follow-up. A total of 480 patients were randomized. During analysis, significantly (P = 0.002) more seromas were detected after OMA (n = 34, 18.1%) compared with primary suture (n = 5, 4.7%) and sublay mesh augmentation (n = 13, 7%). No differences were discovered in any of the other outcomes such as surgical site infection, hematoma, reintervention, or readmission. Multivariable analysis revealed an increase in seroma formation after OMA with an odds ratio of 4.3 (P = 0.004) compared with primary suture and an odds ratio of 2.9 (P = 0.003) compared with sublay mesh augmentation. CONCLUSIONS: On the basis of these short-term results, primary mesh augmentation can be considered a safe procedure with only an increase in seroma formation after OMA, but without an increased risk of surgical site infection.

Assessment of surgery residents' operative skills in the operating theater using a modified Objective Structured Assessment of Technical Skills (OSATS): a prospective multicenter study.

BACKGROUND: With the implementation of competency-based curricula, Objective Structured Assessment of Technical Skills (OSATS) increasingly is being used for the assessment of operative skills. Although evidence for its usefulness has been demonstrated in experimental study designs, data supporting OSATS application in the operating room are limited. This study evaluates the validity and reliability of the OSATS instrument to assess the operative skills of surgery residents in the operating theater. METHODS: Twenty-four residents were recruited from seven hospitals within a general surgical training region and classified equally into three groups according to postgraduate training year (PGY). Each resident had to perform five different types of operations. Surgical performance was measured using a modified OSATS consisting of three scales: Global Rating Scale, Overall Performance Scale, and Alphabetic Summary Scale. Validity and reliability metrics included construct validity (Kruskal-Wallis test) and internal consistency reliability (Cronbach's α coefficient). Spearman's correlation coefficients were calculated to determine correlations between the different scales. RESULTS: Eighteen residents (PGY 1-2 [n = 7]; PGY 3-4 [n = 8]; PGY 5-6 [n = 3]) performed 249 operations. Comparisons of the performance scores revealed that evidence for construct validity depended on the difficulty level of the selected procedures. For individual operations, internal consistency reliability of the Global Rating Scale ranged from 0.93 to 0.95. Scores on the different scales correlated strongly (r = 0.62-0.76, P < .001). CONCLUSION: Assessment of operative skills in the operating theater using this modified OSATS instrument has the potential to establish learning curves, allowing adequate monitoring of residents' progress in achieving operative competence. The Alphabetic Summary Scale seems to be of additional value. Use of the Overall Performance Scale should be reconsidered.

Intramucosal carcinoma of the rectum can be safely treated with transanal endoscopic microsurgery; clinical support of the revised Vienna classification.

AIM: The revised Vienna criteria were proposed for classifying rectal neoplasia and subsequent treatment strategies. Restaging intramucosal carcinoma to a non-invasive subgroup seems logical, but clinical support is lacking. In this study, we investigated whether distinction between intramucosal carcinomas (IMC) and rectal adenoma (RA) is of clinical relevance and whether these neoplasms can all be similarly and safely treated by transanal endoscopic microsurgery (TEM). METHODS: All consecutive patients with IMC and RA, treated with TEM between 1996 and 2010 in tertiary referral centre for TEM were included. Long-term outcome of 88 IMC was compared to 356 pure rectal adenomas (RA). Local recurrence (LR) rate was the primary endpoint. Risk factors for LR were analysed. RESULTS: LR was diagnosed in 7/88 patients (8.0 %) with IMC and in 33/356 patients with primary RA (9.3 %; p = 0.700) and LR-free survival did not differ (p = 0.438). Median time to recurrence was 10 months (IQR IMC 5-30; RA 6-16). Overall recurrence occurred mainly in the first 3 years (38/40; 95 %). None of the LR revealed malignancy on pathological evaluation. No differences could be found in complication rates (IMC 9 %; RA 13 %; p = 0.34). Metastases did not occur in either group. Independent risk factors for LR were irradical margins at final histopathology (HR 2.32; 95 % CI 1.17-4.59; p = 0.016) and more proximal tumours (HR 0.84; 95 % CI 0.77-0.92; P = <0.001). CONCLUSION: In this study, IMC of the rectum and RA have similar recurrence rates. This supports the revised Vienna classification. Both entities can be safely treated with TEM.

Implementing a clinical pathway for hip fractures; effects on hospital length of stay and complication rates in five hundred and twenty six patients.

PURPOSE: Modern management of the elderly with a hip fracture is complex and costly. The aim of this study was to compare the treatment-related hospital length of stay (HLOS) before and after implementing a clinical pathway for patients undergoing hip fracture surgery. METHODS: This was a retrospective, before-and-after study. The first period ranged from June 21, 2008 to November 1, 2009 (N = 212), and the second was from January 7, 2010 to July 7, 2011 (N = 314). The electronic hospital system and patients records were reviewed for demographics, HLOS, mortality, complications and readmissions. RESULTS: In the first period 53 % had a femoral neck fracture, of which 57 % were treated with hemiarthroplasty. In the second period this was 46 % and 71 %. Pertrochanteric fractures were treated with a Gamma nail in 85 % in the first period, and in 92 % in the second period. The median HLOS decreased from nine to six days (p < 0.001). For the hemiarthroplasty group HLOS decreased from nine to seven days (p < 0.001); for internal fixation there was no significant difference (five versus six days, p = 0.557) and after Gamma nailing it decreased from ten to six days (p < 0.001). For mortality no statistically significant difference was found (6 % versus 5 %, p = 0.698). Complications decreased for the Gamma nail group (44 % versus 31 %, p = 0.049). Readmissions for the total group were not different (16 % versus 17 %, p = 0.720). CONCLUSIONS: Implementing a clinical pathway for hip fractures is a safe way to reduce the HLOS and it improves the quality of care.

Surgeons' attitude toward a competency-based training and assessment program: results of a multicenter survey.

BACKGROUND: Currently, most surgical training programs are focused on the development and evaluation of professional competencies. Also in the Netherlands, competency-based training and assessment programs were introduced to restructure postgraduate medical training. The current surgical residency program is based on the Canadian Medical Education Directives for Specialists (CanMEDS) competencies and uses assessment tools to evaluate residents' competence progression. In this study, we examined the attitude of surgical residents and attending surgeons toward a competency-based training and assessment program used to restructure general surgical training in the Netherlands in 2009. METHODS: In 2011, all residents (n = 51) and attending surgeons (n = 108) in 1 training region, consisting of 7 hospitals, were surveyed. Participants were asked to rate the importance of the CanMEDS competencies and the suitability of the adopted assessment tools. Items were rated on a 5-point Likert scale and considered relevant when at least 80% of the respondents rated an item with a score of 4 or 5 (indicating a positive attitude). Reliability was evaluated by calculating the Cronbach's α, and the Mann-Whitney test was applied to assess differences between groups. RESULTS: The response rate was 88% (n = 140). The CanMEDS framework demonstrated good reliability (Cronbach's α = 0.87). However, the importance of the competencies 'Manager' (78%) and 'Health Advocate' (70%) was undervalued. The assessment tools failed to achieve an acceptable reliability (Cronbach's α = 0.55), and individual tools were predominantly considered unsuitable for assessment. Exceptions were the tools 'in-training evaluation report' (91%) and 'objective structured assessment of technical skill' (82%). No significant differences were found between the residents and the attending surgeons. CONCLUSION: This study has demonstrated that, 2 years after the reform of the general surgical residency program, residents and attending surgeons in a large training region in the Netherlands do not acknowledge the importance of all CanMEDS competencies and consider the assessment tools generally unsuitable for competence evaluation.

Transanal endoscopic microsurgery for T1 rectal cancer: size matters!

BACKGROUND: Transanal endoscopic microsurgery (TEM) is considered a curative option for selected T1 rectal cancer. Although TEM is safe, local recurrence (LR) rates after TEM are unacceptably high. Evidence on selection criteria, however, is not abundant. To expand evidence on low- versus high-risk T1 rectal cancer with respect to LR, this study aimed to identify predictive histopathologic factors in a selected group of T1 rectal cancers treated with TEM only. METHODS: The study enrolled 62 patients for whom specimens of the primary tumor containing an invasive T1 carcinoma could be reevaluated. Tumors were scored according to predefined criteria, and analysis of predictive factors for locoregional failure was performed. RESULT: Local recurrence rates at 3 years for tumors 3 cm in size or smaller were significantly lower than for tumors larger than 3 cm (16 vs. 39%; P < 0.03). Combining smaller tumors with submucosal invasion depth and budding led to identifying tumors that likely will not recur (3-year LR rates, 7 and 10%, respectively). CONCLUSIONS: The findings showed that low- and high-risk criteria are too robust for identifying tumors at risk for LR. Tumor size alone or in combination with submucosal invasion depth or tumor budding appeared to be a significant predictive factor for locoregional failure after TEM for T1 rectal cancer.

[A man with a painful right hand]. / Een man met een pijnlijke rechter hand.

A young man visited the Emergency Department with a painful right hand after punching his fist against a wall. He suffered a luxation in the fifth carpometacarpal joint and a fracture at the base of the fourth metacarpal bone which were successfully treated by reposition and plaster bandage for 4 weeks.

Treatment of recurrence after transanal endoscopic microsurgery (TEM) for T1 rectal cancer.

PURPOSE: The aim of this study was to evaluate the management and outcome of local recurrences after transanal endoscopic microsurgery for T1 rectal cancer. METHODS: Consecutive patients who underwent transanal endoscopic microsurgery for pT1 rectal cancer at a Dutch referral center (IJsselland Hospital) were registered in a prospective database. Follow-up was according to Dutch guidelines on rectal cancer, with additional rigid rectoscopy and endorectal ultrasound examinations every 3 months for the first 2 years, and every 6 months thereafter. Annual MRI of the lesser pelvis was added during the last 2 years of the study. Patients with local recurrence during follow-up were selected for individual analysis of outcome. RESULTS: Of a total of 88 patients who underwent transanal endoscopic microsurgery for pT1 rectal cancer, 18 patients (20.5%) had a local recurrence. Median time to local recurrence was 10 (range, 4-50) months. Median age at diagnosis of recurrence was 74 (range, 56-84) years. Of the 18 patients, 2 did not undergo further surgery because of concomitant metastatic disease, and 16 underwent salvage surgery, without need for multivisceral resections. No postoperative mortality was observed. In 15 patients (94%), a microscopically negative excision margin was obtained; in 1 patient, the excision margin was microscopically positive. Median follow-up after salvage surgery was 20 (range, 2-112) months. One patient had a local renewal of recurrence, and 7 patients (39%) had distant metastases. At 3 years, overall survival was 31%; cancer-related survival was 58%. CONCLUSIONS: Recurrent disease after transanal endoscopic microsurgery for T1 rectal cancer is a major problem. Although salvage surgery for achieving local control is feasible in most patients, survival is limited, mainly because of distant metastases. Tailoring selection of T1 rectal cancers and exploring possible adjuvant treatment strategies following salvage procedures should be the next steps toward improving survival.

Preoperative radiotherapy has no value for patients with T2-3, N0 adenocarcinomas of the rectum.

BACKGROUND: Treatment of rectal cancer with preoperative radiotherapy followed by total mesorectal excision is nowadays the standard treatment. It reduces local recurrences and improves overall survival. However, in patients with T2-3, N0 rectal cancer, the role of preoperative radiotherapy remains controversial. The aim of this study was to review the benefit of radiotherapy in T2 and T3, N0 rectal cancer patients. METHODS: Between 1996 and 2003, 103 patients with T2-3, N0 rectal cancer were identified in our prospective database. This study evaluated time to local recurrence, distant metastases and overall survival. RESULTS: Median follow-up was 4.3 years. The 5-year local control rate was 94%. The 5-year overall survival was 65%. The 5-year disease-free survival rate was 82%. Preoperative radiotherapy did not show any statistical differences. Abdominal perineal resection and T3 tumors negatively influenced overall survival (p = 0.02). Advanced age was of significant importance in overall survival. CONCLUSIONS: Preoperative radiotherapy does not seem to be of significant importance in patients with T2-3, N0 rectal cancer regarding local recurrence and survival. Since preoperative radiotherapy is associated with short- and long-term morbidity, patients with T2-3, N0 tumors should be identified and treated with surgery alone.

Total mesorectal excision for rectal cancer in an unselected population: quality assessment in a low volume center.

OBJECTIVE: The aim of this study was to review the results and long-term outcome after total mesorectal excision (TME) for adenocarcinoma of the rectum in an unselected population in a community teaching hospital. MATERIALS AND METHODS: Between 1996 and 2003, 210 patients with rectal cancer were identified in our prospective database, containing patient characteristics, radiotherapy plans, operation notes, histopathological reports, and follow-up details. An evaluation of prognostic factors for local recurrence, distant metastases, and overall survival was performed. RESULTS: The mean age at diagnosis was 69 years (range 40-91 years). A total of 145 patients were treated by anterior rectal resection; 65 patients had to undergo an abdominoperineal resection (APR). Anastomotic leakage rate was 5%. Postoperative mortality was 3%. After a median follow-up of 3.6 years, the local recurrence-free rate in patients with microscopically complete resections was 91%. The 5-year overall survival rate was 58%. An increased serum carcinoembryonic antigen, an APR, positive lymph nodes, and an incomplete resection all significantly influenced the 5-year overall survival and local recurrence rate. In a multivariate analysis, age was the most important prognostic factor for overall survival. CONCLUSIONS: Patients with rectal cancer can safely be treated with TME in a community teaching hospital and leads to a good overall survival and an excellent local control. In patients aged above 80, treatment-related mortality is an important competitive risk factor, which obscures the positive effect of modern rectal cancer treatment.

Spinal or local anesthesia in lichtenstein hernia repair: a randomized controlled trial.

BACKGROUND: With established protocols lacking, the choice of anesthetic technique remains arbitrary in inguinal hernia repair. Well-designed studies in this subject are important because of the gap or discrepancy between available scientific evidence and clinical practice. METHODS: Between August 2004 and June 2006, a multicenter prospective clinical trial was performed in which 100 patients with unilateral primary inguinal hernia were randomized to spinal or local anesthesia. Clinical examination took place within 2 weeks postoperatively and at 3 months in the outpatient clinic. RESULTS: Analysis of postoperative visual analogue scale scores showed that patients operated under local anesthesia had significant less pain shortly after surgery (P = 0.021). Significantly more urinary retention (P < 0.001) and more overnight admissions (P = 0.004) occurred after spinal anesthesia. Total operating time is significantly shorter in the local anesthesia group (P < 0.001). No significant differences were found between the 2 groups with respect to the activities of daily life and quality of life. CONCLUSIONS: Our study provides evidence that local anesthesia is superior to spinal anesthesia in inguinal hernia repair. Local anesthesia in primary, inguinal hernia repairs should be the method of choice.