Laurents P. S. Stassen

Objective assessment of technical surgical skills.

Surgeons are increasingly being scrutinized for their performance and there is growing interest in objective assessment of technical skills. The purpose of this study was to review all evidence for these methods, in order to provide a guideline for use in clinical practice.

High-Volume versus Low-Volume for Esophageal Resections for Cancer: The Essential Role of Case-Mix Adjustments based on Clinical Data

BackgroundMost studies addressing the volume–outcome relationship in complex surgical procedures use hospital mortality as the sole outcome measure and are rarely based on detailed clinical data. The lack of reliable information about comorbidities and tumor stages makes the conclusions of these studies debatable.The purpose of this study was to compare outcomes for esophageal resections for cancer in low- versus high-volume hospitals, using an extensive set of variables concerning case-mix and outcome measures, including long-term survival.MethodsClinical data, from 903 esophageal resections performed between January 1990 and December 1999, were retrieved from the original patients’ files. Three hundred and forty-two patients were operated on in 11 low-volume hospitals (<7 resections/year) and 561 in a single high-volume center.ResultsMortality and morbidity rates were significantly lower in the high-volume center, which had an in-hospital mortality of 5 vs 13% (P < .001). On multivariate analysis, hospital volume, but also the presence of comorbidity proved to be strong prognostic factors predicting in-hospital mortality (ORs 3.05 and 2.34). For stage I and II disease, there was a significantly better 5-year survival in the high-volume center. (P = .04).ConclusionsHospital volume and comorbidity patterns are important determinants of outcome in esophageal cancer surgery. Strong clinical endpoints such as in-hospital mortality and survival can be used as performance indicators, only if they are joined by reliable case-mix information.

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)

BackgroundRecently, 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/DesignIn this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmanns 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 Hartmanns 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 power = 90%) in favour of the patients with resection with primary anastomosis. Secondary endpoints for both arms are the number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs.DiscussionThe Ladies trial is a nationwide multicentre randomised trial on perforated diverticulitis that will provide evidence on the merits of laparoscopic lavage and drainage for purulent generalised peritonitis and on the optimal resectional strategy for both purulent and faecal generalised peritonitis.Trial registrationNederlands Trial Register NTR2037

Transanal endoscopic microsurgery for rectal cancer

If curation is intended for rectal cancer, total mesorectal excision with autonomic nerve preservation (TME) is the gold standard. Transanal resection is tempting because of low mortality and morbidity rates. However, inferior tumour control, provoked by the limitations of the technique, resulted in its cautious application and use mainly for palliation. Transanal endoscopic microsurgery (TEM) is a minimal invasive technique for the local resection of rectal tumours. It is a one-port system, introduced transanally. An optical system with a 3D-view, 6-fold magnification and resolution as the human eye, together with the creation of a stabile pneumorectum, and specially designed instruments allow full-thickness excision under excellent view and a proper histological examination. The technique can also be applied for larger and more proximal tumours. Mortality, morbidity as well as incomplete excision rates are minimal. Local recurrence and survival rates seem comparable to TME in early rectal cancer. TEM is the method of choice when local resection of rectal cancer is indicated. Results justify a re-evaluation of the indications for the local excision of rectal cancer with a curative intent.

Quality of life after transanal endoscopic microsurgery and total mesorectal excision in early rectal cancer

Objective  Total mesorectal excision (TME) is the gold standard in rectal cancer, if curation is intended. Transanal endoscopic microsurgery (TEM) is a much safer technique and seems to have comparable survival in early rectal cancer. The impact of both procedures on quality of life has never been compared. In this study we compared quality of life after TEM and TME.

Training Physicians to Provide High-Value, Cost-Conscious Care: A Systematic Review

IMPORTANCE Increasing health care expenditures are taxing the sustainability of the health care system. Physicians should be prepared to deliver high-value, cost-conscious care. OBJECTIVE To understand the circumstances in which the delivery of high-value, cost-conscious care is learned, with a goal of informing development of effective educational interventions. DATA SOURCES PubMed, EMBASE, ERIC, and Cochrane databases were searched from inception until September 5, 2015, to identify learners and cost-related topics. STUDY SELECTION Studies were included on the basis of topic relevance, implementation of intervention, evaluation of intervention, educational components in intervention, and appropriate target group. There was no restriction on study design. DATA EXTRACTION AND SYNTHESIS Data extraction was guided by a merged and modified version of a Best Evidence in Medical Education abstraction form and a Cochrane data coding sheet. Articles were analyzed using the realist review method, a narrative review technique that focuses on understanding the underlying mechanisms in interventions. Recurrent patterns were identified in the data through thematic analyses. Resulting themes were discussed within the research team until consensus was reached. MAIN OUTCOMES AND MEASURES Main outcomes were factors that promote education in delivering high-value, cost-conscious care. FINDINGS The initial search identified 2650 articles; 79 met the inclusion criteria, of which 14 were randomized clinical trials. The majority of the studies were conducted in North America (78.5%) using a pre-post interventional design (58.2%; at least 1619 participants); they focused on practicing physicians (36.7%; at least 3448 participants), resident physicians (6.3%; n = 516), and medical students (15.2%; n = 275). Among the 14 randomized clinical trials, 12 addressed knowledge transmission, 7 reflective practice, and 1 supportive environment; 10 (71%) concluded that the intervention was effective. The data analysis suggested that 3 factors aid successful learning: (1) effective transmission of knowledge, related, for example, to general health economics and prices of health services, to scientific evidence regarding guidelines and the benefits and harms of health care, and to patient preferences and personal values (67 articles); (2) facilitation of reflective practice, such as providing feedback or asking reflective questions regarding decisions related to laboratory ordering or prescribing to give trainees insight into their past and current behavior (56 articles); and (3) creation of a supportive environment in which the organization of the health care system, the presence of role models of delivering high-value, cost-conscious care, and a culture of high-value, cost-conscious care reinforce the desired training goals (27 articles). CONCLUSIONS AND RELEVANCE Research on educating physicians to deliver high-value, cost-conscious care suggests that learning by practicing physicians, resident physicians, and medical students is promoted by combining specific knowledge transmission, reflective practice, and a supportive environment. These factors should be considered when educational interventions are being developed.

Long-term Outcome of an Organ Preservation Program After Neoadjuvant Treatment for Rectal Cancer

BACKGROUND The aim of this study was to establish the oncological and functional results of organ preservation with a watch-and-wait approach (W&W) and selective transanal endoscopic microsurgery (TEM) in patients with a clinical complete or near-complete response (cCR) after neoadjuvant chemoradiation for rectal cancer. METHODS Between 2004 and 2014, organ preservation was offered if response assessment with digital rectal examination, endoscopy, and MRI showed (near) cCR. Watch-and-wait was offered for cCR, and two options were offered for near cCR: TEM or reassessment after three months. Follow-up included endoscopy and MRIs every three months during the first year, and every six months thereafter. Long-term outcome was assessed with Kaplan-Meier curves. Functional outcome was assessed with colostomy-free survival and Vaizey incontinence score (0 = perfect continence, 24 = totally incontinent). RESULTS One hundred patients were included, with median follow-up of 41.1 months. Sixty-one had cCR at initial response assessment. Thirty-nine had near cCR, of whom 24 developed cCR at the second assessment and 15 patients underwent TEM (9 ypT0, 1 ypT1, 5 ypT2). Fifteen patients developed a local regrowth (12 luminal, 3 nodal), all salvageable and within 25 months. Five patients developed metastases, and five patients died. Three-year overall survival was 96.6% (95% confidence interval [CI] = 89.9% to 98.9%), distant metastasis-free survival was 96.8% (95% CI = 90.4% to 99.0%), local regrowth-free survival was 84.6% (95% CI = 75.8% to 90.5%), and disease-free survival was 80.6% (95% CI = 70.9% to 87.4%). Colostomy-free survival was 94.8% (95% CI = 88.0% to 97.8%), with a good continence after watch-and-wait (Vaizey = 3.4, SD = 3.9) and moderate after TEM (Vaizey = 9.7, SD = 5.1). CONCLUSIONS Organ preservation appears oncologically safe for selected rectal cancer patients with a cCR or near cCR after neoadjuvant chemoradiation when applying strict selection criteria and frequent follow-up, including endoscopy and MRI. The low colostomy rate and the good long-term functional outcome warrant discussing this option with the patient as an alternative to major surgery.

Systematic review and meta-analysis of surgical interventions for high cryptoglandular perianal fistula.

PurposePerianal fistulas, and specifically high perianal fistulas, remain a surgical treatment challenge. Many techniques have, and still are, being developed to improve outcome after surgery. A systematic review and meta-analysis was performed for surgical treatments for high cryptoglandular perianal fistulas.MethodsMedline (Pubmed, Ovid), Embase and The Cochrane Library databases were searched for relevant randomized controlled trials on surgical treatments for high cryptoglandular perianal fistulas. Two independent reviewers selected articles for inclusion based on title, abstract and outcomes described. The main outcome measurement was the recurrence/healing rate. Secondary outcomes were continence status, quality of life and complications.ResultsThe number of randomized trials available was low. Fourteen studies could be included in the review. A meta-analysis could only be performed for the mucosa advancement flap versus the fistula plug, and did not show a result in favour of either technique in recurrence or complication rate. The mucosa advancement flap was the most investigated technique, but did not show an advantage over any other technique. Other techniques identified in randomized studies were seton treatment, medicated seton treatment, fibrin glue, autologous stem cells, island flap anoplasty, rectal wall advancement flap, ligation of intersphincteric fistula tract, sphincter reconstruction, sphincter-preserving seton and techniques combined with antibiotics. None of these techniques seem superior to each other.ConclusionsThe best surgical treatment for high cryptoglandular perianal fistulas could not be identified. More randomized controlled trials are needed to find the best treatment. The mucosa advancement flap is the most investigated technique available.

Risks of minimally invasive surgery underestimated: a report of the Dutch Health Care Inspectorate

The Author(s) 2009. This article is published with open access at Springerlink.com Endoscopic surgery is known for its different eye–hand coordination and its learning curves. It encompasses complex and sensitive equipment that requires different maintenance and quality control. Despite the development of dedicated training programs and extensive research justifying the endoscopic revolution, the Dutch Health Care Inspectorate (DHI) [1] recently surprised endoscopic surgeons with its report entitled Risks of Minimally Invasive Surgery Underestimated [2]. In this report, the Inspectorate expressed its sincere concern regarding endoscopic surgery in The Netherlands. The DHI report was based on investigations done by the Inspectorate initiated by unusual observations of incidents associated with endoscopic surgery. The investigations consisted of questionnaires and on-site visits to hospitals and endoscopic surgeons. Such activity is part of DHI’s task to control the quality of health care in general.

Randomized controlled trial of transoral incisionless fundoplication vs. proton pump inhibitors for treatment of gastroesophageal reflux disease.

Objectives:Transoral incisionless fundoplication (TIF) was developed in an attempt to create a minimally invasive endoscopic procedure that mimics antireflux surgery. The objective of this trial was to evaluate effectiveness of TIF compared with proton pump inhibition in a population consisting of gastroesophageal reflux disease (GERD) patients controlled with proton pump inhibitors (PPIs) who opted for an endoscopic intervention over lifelong drug dependence.Methods:Patients with chronic GERD were randomized (2:1) for TIF or continuation of PPI therapy. American Society of Anesthesiologists >2, body mass index >35 kg/m2, hiatal hernia >2 cm, and esophageal motility disorders were exclusion criteria. Primary outcome measure was GERD-related quality of life. Secondary outcome measures were esophageal acid exposure, number of reflux episodes, PPI usage, appearance of the gastroesophageal valve, and healing of reflux esophagitis. Crossover for the PPI group was allowed after 6 months.Results:A total of 60 patients (TIF n=40, PPI n=20, mean body mass index 26 kg/m2, 37 male) were included. At 6 months, GERD symptoms were more improved in the TIF group compared with the PPI group (P<0.001), with a similar improvement of distal esophageal acid exposure (P=0.228) compared with baseline. The pH normalization for TIF group and PPI group was 50% and 63%, respectively. All patients allocated for PPI treatment opted for crossover. At 12 months, quality of life remained improved after TIF compared with baseline (P<0.05), but no improvement in esophageal acid exposure compared with baseline was found (P=0.171) and normalization of pH was accomplished in only 29% in conjunction with deteriorated valve appearances at endoscopy and resumption of PPIs in 61%.Conclusion:Although TIF resulted in an improved GERD-related quality of life and produced a short-term improvement of the antireflux barrier in a selected group of GERD patients, no long-term objective reflux control was achieved.