Hans Groenewoud

Surgical techniques for parastomal hernia repair: a systematic review of the literature.

Background:Parastomal hernias are a frequent complication of enterostomies that require surgical treatment in approximately half of patients. This systematic review aimed to evaluate and compare the safety and effectiveness of the surgical techniques available for parastomal hernia repair. Methods:Systematic review was performed in accordance with PRISMA. Assessment of methodological quality and selection of studies of parastomal hernia repair was done with a modified MINORS. Subgroups were formed for each surgical technique. Primary outcome was recurrence after at least 1-year follow-up. Secondary outcomes were mortality and postoperative morbidity. Outcomes were analyzed using weighted pooled proportions and logistic regression. Results:Thirty studies were included with the majority retrospective. Suture repair resulted in a significantly increased recurrence rate when compared with mesh repair (odds ratio [OR] 8.9, 95% confidence interval [CI] 5.2–15.1; P < 0.0001). Recurrence rates for mesh repair ranged from 6.9% to 17% and did not differ significantly. In the laparoscopic repair group, the Sugarbaker technique had less recurrences than the keyhole technique (OR 2.3, 95% CI 1.2–4.6; P = 0.016). Morbidity did not differ between techniques. The overall rate of mesh infections was low (3%, 95% CI 2) and comparable for each type of mesh repair. Conclusions:Suture repair of parastomal hernia should be abandoned because of increased recurrence rates. The use of mesh in parastomal hernia repair significantly reduces recurrence rates and is safe with a low overall rate of mesh infection. In laparoscopic repair, the Sugarbaker technique is superior over the keyhole technique showing fewer recurrences.

Adrenal vein sampling versus CT scan to determine treatment in primary aldosteronism: an outcome-based randomised diagnostic trial

BACKGROUND The distinction between unilateral aldosterone-producing adenoma or bilateral adrenal hyperplasia as causes of primary aldosteronism is usually made by adrenal CT or by adrenal vein sampling (AVS). Whether CT or AVS represents the best test for diagnosis remains unknown. We aimed to compare the outcome of CT-based management with AVS-based management for patients with primary aldosteronism. METHODS In a randomised controlled trial, we randomly assigned patients with aldosteronism to undergo either adrenal CT or AVS to determine the presence of aldosterone-producing adenoma (with subsequent treatment consisting of adrenalectomy) or bilateral adrenal hyperplasia (subsequent treatment with mineralocorticoid receptor antagonists). The primary endpoint was the intensity of drug treatment for obtaining target blood pressure after 1 year of follow-up, in the intention-to-diagnose population. Intensity of drug treatment was expressed as daily defined doses. Key secondary endpoints included biochemical outcome in patients who received adrenalectomy, health-related quality of life, cost-effectiveness, and adverse events. This trial is registered with ClinicalTrials.gov, number NCT01096654. FINDINGS We recruited 200 patients between July 6, 2010, and May 30, 2013. Of the 184 patients that completed follow-up, 92 received CT-based treatment (46 adrenalectomy and 46 mineralocorticoid receptor antagonist) and 92 received AVS-based treatment (46 adrenalectomy and 46 mineralocorticoid receptor antagonist). We found no differences in the intensity of antihypertensive medication required to control blood pressure between patients with CT-based treatment and those with AVS-based treatment (median daily defined doses 3·0 [IQR 1·0-5·0] vs 3·0 [1·1-5·9], p=0·52; median number of drugs 2 [IQR 1-3] vs 2 [1-3], p=0·87). Target blood pressure was reached in 39 (42%) patients and 41 (45%) patients, respectively (p=0·82). On secondary endpoints we found no differences in health-related quality of life (median RAND-36 physical scores 52·7 [IQR 43·9-56·8] vs 53·2 [44·0-56·8], p=0·83; RAND-36 mental scores 49·8 [43·1-54·6] vs 52·7 [44·9-55·5], p=0·17) for CT-based and AVS-based treatment. Biochemically, 37 (80%) of patients with CT-based adrenalectomy and 41 (89%) of those with AVS-based adrenalectomy had resolved hyperaldosteronism (p=0·25). A non-significant mean difference of 0·05 (95% CI -0·04 to 0·13) in quality-adjusted life-years (QALYs) was found to the advantage of the AVS group, associated with a significant increase in mean health-care costs of €2285 per patient (95% CI 1323-3248). At a willingness-to-pay value of €30 000 per QALY, the probability that AVS compared with CT constitutes an efficient use of health-care resources in the diagnostic work-up of patients with primary aldosteronism is less than 0·2. There was no difference in adverse events between groups (159 events of which nine were serious vs 187 events of which 12 were serious) for CT-based and AVS-based treatment. INTERPRETATION Treatment of primary aldosteronism based on CT or AVS did not show significant differences in intensity of antihypertensive medication or clinical benefits for patients after 1 year of follow-up. This finding challenges the current recommendation to perform AVS in all patients with primary aldosteronism. FUNDING Netherlands Organisation for Health Research and Development-Medical Sciences, Institute of Cardiology, Warsaw.

To drain or not to drain: a cumulative meta-analysis of the use of routine abdominal drains after pancreatic resection

BACKGROUND To warrant the adoption or rejection of health care interventions in daily practice, it is important to establish the point at which the available evidence is considered sufficiently conclusive. This process must avoid bias resulting from multiple testing and take account of heterogeneity across studies. The present paper addresses the issue of whether the available evidence may be considered sufficiently conclusive to continue or discontinue the current practice of postoperative abdominal drainage after pancreatic resection. METHODS A systematic review was conducted of randomized and non-randomized studies comparing outcomes after routine intra-abdominal drainage with those after no drainage after pancreatic resection. Studies were retrieved from the PubMed, Cochrane Central Trial Register and EMBASE databases and meta-analysed cumulatively, adjusting for multiple testing and heterogeneity using the iterated logarithm method. RESULTS Three reports, describing, respectively, one randomized and two non-randomized studies with a comparative design, met the inclusion criteria predefined for primary studies reporting on drain management and complications after pancreatic resection. These studies included 89, 179 and 226 patients, respectively. The absolute differences in rates of postoperative complications in these studies were -6.4%, -9.5% and -6.3%, respectively, in favour of the no-drain groups. The cumulative risk difference in major complications, adjusted for multiple testing and heterogeneity, was -7.8%, with a 95% confidence interval of -20.2% to 4.7% (P = 0.214). CONCLUSIONS The routine use of abdominal drains after pancreatic resection may result in a higher risk for major complications, but the evidence is inconclusive.

Pain exposure physical therapy (PEPT) compared to conventional treatment in complex regional pain syndrome type 1: a randomised controlled trial

Objective To compare the effectiveness of pain exposure physical therapy (PEPT) with conventional treatment in patients with complex regional pain syndrome type 1 (CRPS-1) in a randomised controlled trial with a blinded assessor. Setting The study was conducted at a level 1 trauma centre in the Netherlands. Participants 56 adult patients with CRPS-1 participated. Three patients were lost to follow-up. Interventions Patients received either PEPT in a maximum of five treatment sessions, or conventional treatment following the Dutch multidisciplinary guideline. Measurements Outcomes were assessed at baseline and at 3, 6 and 9 months after randomisation. The primary outcome measure was the Impairment level Sum Score—Restricted Version (ISS-RV), consisting of visual analogue scale for pain (VAS-pain), McGill Pain Questionnaire, active range of motion (AROM) and skin temperature. Secondary outcome measures included Pain Disability Index (PDI); muscle strength; Short Form 36 (SF-36); disability of arm, shoulder and hand; Lower Limb Tasks Questionnaire (LLTQ); 10 m walk test; timed up-and-go test (TUG) and EuroQol-5D. Results The intention-to-treat analysis showed a clinically relevant decrease in ISS-RV (6.7 points for PEPT and 6.2 points for conventional treatment), but the between-group difference was not significant (0.96, 95% CI −1.56 to 3.48). Participants allocated to PEPT experienced a greater improvement in AROM (between-group difference 0.51, 95% CI 0.07 to 0.94; p=0.02). The per protocol analysis showed larger and significant between-group effects on ISS-RV, VAS-pain, AROM, PDI, SF-36, LLTQ and TUG. Conclusions We cannot conclude that PEPT is superior to conventional treatment for patients with CRPS-1. Further high-quality research on the effects of PEPT is warranted given the potential effects as indicated by the per protocol analysis. Trial registration numbers NCT00817128 and NTR 2090.

A peritonitis model with low mortality and persisting intra-abdominal abscesses

Intra‐abdominal abscesses are a potential source of recurrent or residual infection after surgical intervention for secondary peritonitis. The development of therapies requires a model which combines low mortality with the formation of persisting abscesses and which is also suitable to study the local inflammatory response. Male Wistar rats were injected intraperitoneally with a mixture of sterile rat faeces, increasing doses of E. coli (104−108 cfu/ml) and a fixed dose of B. Fragilis (104 cfu/ml). After one h a laparotomy was performed and the peritoneal cavity was debrided. Blood samples were taken under anaesthesia after 6 and 24 h. Abdominal fluid samples were collected (by laparotomy) after 24 and 72 h. The rats were killed after 5 days and the abdomen was inspected for abscesses. Mortality was 90% in the two groups with the highest doses of E. coli and 30% in those with the two lowest doses. In the latter groups all surviving rats but one showed intraabdominal abscesses and bacteremia was encountered frequently, especially after 24 h in the 105 cfu E. coli group. The groups receiving 104−106 cfu E. coli showed similar plasma IL‐6 concentrations after 6 h which were lowered significantly after 24 h. No circulating TNF‐α was found. Considerable concentrations of TNF‐α, IL‐6, IL‐1β, and IL‐10, were found in the peritoneal fluid after 24 h but no differences were observed between the contro groups and those receiving 104−106 cfu E. coli. At 72 h cytokine levels were reduced significantly and remained the highest in the animals dosed with 106 cfu E. coli. The present model is suitable to study the mechanisms involved in, and prevention of, intra‐abdominal abscess formation after surgical treatment of generalized peritonitis.

Can Surgical Oncologists Reliably Predict the Likelihood for Non-SLN Metastases in Breast Cancer Patients?

BackgroundIn approximately 40% of the breast cancer patients with sentinel lymph node (SLN) metastases, additional nodal metastases are detected in the completion axillary lymph node dissection (cALND). The MSKCC nomogram can help to quantify a patient’s individual risk for non-SLN metastases with fairly accurate predicted probability. The aim of this study was to compare the predictions of surgical oncologists for non-SLN metastases with nomogram results and to clarify the impact of nomogram results on clinical decision-making.MethodsQuestionnaires, containing patient scenarios, were sent to surgical oncologists involved in breast cancer care. The surgeon was asked to predict the probability for non-SLN metastases for the first five scenarios. For the remaining scenarios, the patient’s actuarial likelihood, calculated by the nomogram, was supplied. The surgeon was asked whether or not (s)he would perform a cALND. The type of hospital and the surgeon’s experience were registered.ResultsThe concordance-index amounted to 0.78, indicating moderate concurrence between the surgical predictions and nomogram results. The intersurgeon variation was important. About 25% of the surgeons was influenced by nomogram information and decided in one or more patients to abandon the cALND. Neither the type of hospital nor experience influenced predicting abilities or the clinical decision-making process.ConclusionIndividual predictions of surgical oncologists for non-SLN metastases do not correlate well with the MSKCC nomogram. The distribution between intersurgeon predictions for one scenario is important. Therefore, the nomogram is superior to clinical estimations for predicting the likelihood for non-SLN metastases.

Identification of the Best Direct-Acting Antiviral Regimen for Patients With Hepatitis C Virus Genotype 3 Infection: A Systematic Review and Network Meta-analysis

BACKGROUND & AIMS Direct‐acting antivirals (DAAs) are effective in the treatment of chronic hepatitis C virus (HCV) infection, although results for patients infected with genotype 3 are suboptimal. There are several regimens available, however, direct comparisons have not been made and are unlikely to occur. We aimed to identify the most effective DAA regimen for patients infected with HCV genotype 3 and to assess the role of ribavirin. METHODS We conducted a systematic search of PubMed, Embase, and Web of Science databases through March 2016. We performed a Bayesian network meta‐analysis using a random‐effects model to indirectly compare regimens in patients with and without cirrhosis. We calculated mean estimated sustained virologic response (SVR) with 95% credible intervals (95% CrI) per regimen and effect of ribavirin as odds ratio. We focused on current recommended regimens and regimens under evaluation by regulatory authorities. RESULTS Our search identified 2167 articles; 27 studies (comprising 3415 patients) were included. Among patients without cirrhosis, the greatest rates of SVR were estimated for those receiving sofosbuvir + velpatasvir with ribavirin (99%; 95% CrI, 98%–100%) and without ribavirin (97%; 95% CrI, 95%–99%), sofosbuvir + daclatasvir + ribavirin (96%; 95% CrI, 92%–98%), and sofosbuvir + peginterferon + ribavirin (95%; 95% CrI, 91%–98%), all for 12 weeks. Among patients with cirrhosis, the highest rates of SVR were estimated for those receiving sofosbuvir + velpatasvir for 24 weeks (96%; 95% CrI, 92%–99%), sofosbuvir + daclatasvir + ribavirin for 24 weeks (94%; 95% CrI, 87%–98%), and sofosbuvir + velpatasvir + ribavirin for 12 weeks (94%; 95% CrI, 86%–98%). Ribavirin increases efficacy in patients with and without cirrhosis (odds ratio, 2.6–4.5). CONCLUSIONS An indirect comparison of DAA‐based treatments, using Bayesian network meta‐analysis, found regimens containing sofosbuvir and velpatasvir to be the best option for patients with HCV genotype 3 infection. Our analyses indicated that ribavirin significantly increases SVR rates and should be considered if tolerated.

The effectiveness and cost evaluation of pain exposure physical therapy and conventional therapy in patients with complex regional pain syndrome type 1. Rationale and design of a randomized controlled trial.

BackgroundPain Exposure Physical Therapy is a new treatment option for patients with Complex Regional Pain Syndrome type 1. It has been evaluated in retrospective as well as in prospective studies and proven to be safe and possibly effective. This indicates that Pain Exposure Physical Therapy is now ready for clinical evaluation. The results of an earlier performed pilot study with an n = 1 design, in which 20 patients with Complex Regional Pain Syndrome type 1 were treated with Pain Exposure Physical Therapy, were used for the design and power calculation of the present study.After completion and evaluation of this phase III study, a multi-centre implementation study will be conducted.The aim of this study is to determine whether Pain Exposure Physical Therapy can improve functional outcomes in patients with Complex Regional Pain Syndrome type 1.Methods/designThis study is designed as a single-blinded, randomized clinical trial. 62 patients will be randomized with a follow-up of 9 months to demonstrate the expected treatment effect. Complex Regional Pain Syndrome type 1 is diagnosed in accordance with the Bruehl/International Association for the Study of Pain criteria. Conventional therapy in accordance with the Dutch guideline will be compared with Pain Exposure Physical Therapy. Primary outcome measure is the Impairment level SumScore, restricted version.DiscussionThis is the first randomized controlled study with single blinding that has ever been planned in patients with Complex Regional Pain Syndrome type 1 and does not focus on a single aspect of the pain syndrome but compares treatment strategies based on completely different pathophysiological and cognitive theories.Trial registrationClinical trials NCT00817128; National Trial Register NTR2090

Nutritional indicators for gastrointestinal symptoms in female runners: the 'Marikenloop study'

Objectives Among runners the reported prevalence of exercise-induced gastrointestinal (GI) symptoms is high (25%–83%). We aimed to investigate the prevalence of GI symptoms in women during a 5–10 km run in general and to explore the association between nutritional intakes and GI symptoms. Setting As part of the Marikenloop-study (a cohort study to identify predictor variables of running injuries), a cross-sectional questionnaire was distributed in interested runners of the ‘2013 Marikenloop’. Participants 433 female runners filled in the questionnaire. Primary and secondary outcome measures The primary outcome measure was the frequency of running-related GI symptoms during running in general and during the last (training) run. Furthermore, dietary intake was determined before and during this run. Secondary outcome measures were several demographic and anthropometric variables. Results During running in general, 40% of the participants suffered from GI symptoms and during their last run, 49%. The GI symptoms side ache, flatulence, urge to defecate and regurgitation and/or belching were most commonly reported. Lower age (OR=0.98, 95% CI 0.96 to 1.00), minor running experience (OR=3.1, 95% CI 1.7 to 5.7), higher body mass index (OR=1.1, 95% CI 1.0 to 1.2), consuming carbohydrate-containing drinks during running (OR=10.5, 95% CI 1.4 to 80.3) and experiencing GI symptoms during running in general OR=5.0, 95% CI 3.2 to 7.8) significantly contributed to GI symptoms during the last run in the logistic regression analysis. In contrast, time of eating and carbohydrate-containing drinks consumed prior to the run were not related to GI symptoms. Conclusions In conclusion, the current study confirms the high prevalence of GI symptoms in female runners. Several predictor variables contributed to the GI symptoms but more research is needed to specify the effects of prerunning eating and carbohydrate-containing drinks on GI symptoms during running. Trial registration number Marikenloop study 2013: 50-50310-98-156 (ZonMw).

The Qualification of Outcome after Cervical Spine Surgery by Patients Compared to the Neck Disability Index

Objective The Neck Disability Index (NDI) is a patient self-assessed outcome measurement tool to assess disability, and that is frequently used to evaluate the effects of the treatment of neck-related problems. In individualized medicine it is mandatory that patients can interpret data in order to choose a treatment. A change of NDI or an absolute NDI is generally meaningless to a patient. Therefore, a correlation between the qualification of the clinical situation rated by the patient and the NDI score was evaluated. Methods Patients who completed an NDI after anterior surgery because of symptomatic single level degenerative cervical disc disease were asked one month after completion of the NDI to qualify their clinical situation of a 5-item Likert scale varying from excellent to bad. Since a clear distinction between the categories was not possible based on the total NDI score, a ROC-curve was built, and the AUC computed in order to estimate best dichotomization in qualification of the clinical situation. The best corresponding cut-off point for the NDI total score was found by studying sensitivity and specificity for all possible cut-off points. Results 102 patients were included. The highest AUC was obtained by dichotomizing the qualification into a group with good outcome and less-good outcome. The highest sensitivity and specificity for the dichotomized qualification as good outcome corresponded to a NDI ≤ 7. Sensitivity was 81.08% and specificity was 78.57%. Conclusion This is the first study that correlated the qualification of the situation by the patients themselves and NDI. An NDI ≤ 7 corresponded to a good outcome according to the patients. This is valuable information to inform patients in their decision for any treatment.