Development and pilot-testing of a condition-specific instrument to assess the quality-of-life in children and adolescents born with esophageal atresia.

The survival rate of children with esophageal atresia has today reached 95%. However, children are at risk of chronic morbidity related to esophageal and respiratory dysfunction, and associated anomalies. This study describes the pilot testing of a condition-specific health-related quality-of-life instrument for children with esophageal atresia in Sweden and Germany, using a patient-derived development approach consistent with international guidelines. Following a literature review, standardized focus groups were conducted with 30 Swedish families of children with esophageal atresia aged 2-17 years. The results were used for item generation of two age-specific pilot questionnaire versions. These were then translated from Swedish into German with considerations of linguistic and semantical perspectives. The 30-item pilot questionnaire for children aged 2-7 years was completed by 34 families (parent report), and the 50-item pilot questionnaire for children aged 8-17 years was completed by 52 families (51 child report, 52 parent report), with an overall response rate of 96% in the total sample. Based on predefined psychometric criteria, poorly performing items were removed, resulting in an 18-item version with three domains (Eating, Physical health and treatment, Social isolation and stress,) for children aged 2-7 years and a 26-item version with four domains (Eating, Social relationships, Body perception, and Health and well-being) for children aged 8-17 years. Both versions demonstrated good internal consistency reliability and acceptable convergent and known-groups validity for the total scores. The study identified specific health-related quality-of-life domains for pediatric patients with esophageal atresia, highlighting issues that are important for follow-up care. After field testing in a larger patient sample, this instrument can be used to enhance the evaluation of pediatric surgical care.

Early complications after esophageal atresia repair: analysis of a German health insurance database covering a population of 8 million.

The treatment of esophageal atresia is not centralized in Germany. Therefore, high numbers of departments are involved. Data on the results of esophageal atresia repair from Germany are lacking. The aim of this study was to evaluate the early postoperative results after repair of esophageal atresia based on unbiased data of a German health insurance. We aimed to determine whether characteristics of the departments had an impact on outcome and compared the results from this study with the literature data from centers with a high caseload. Data of a German health insurance covering ∼10% of the population were analyzed. All patients who had undergone esophageal atresia repair from January 2007 to August 2012 were included. Follow-up data of 1 year postoperatively were analyzed. The potential impact of various characteristics of the treating surgical institutions was assessed. Results were compared with the latest international literature. Seventy-five patients with esophageal atresia underwent reconstructive surgery in 37 departments. The incidences of anastomotic leak (3%) and recurrent tracheoesophageal fistula (7%) were comparable with the literature (both 2-8%). Anastomotic stricture required dilatation in 57% of patients (mean 5.1 ± 5.6 dilatations) comparing unfavorably to most, but not all international reports. During 1-year follow-up, 93% of the patients were readmitted at least once (mean 3.9 ± 3.1 admissions). The incidence of complications did not correlate with any of the characteristics of the treating institutions such as academic affiliation, the number of consultants, beds, and preterm infants treated per year (all P > 0.05). Based on unbiased data, postoperative results after repair of esophageal atresia in Germany are comparable with recently published reports from international single centers. A correlation between the complication rate and characteristics of the treating institutions was not identified.

[Ethical conflicts in pediatric surgery: high-performance medicine and the economical environment]. / Ethische Konflikte in der Kinderchirurgie : Hochleistungsmedizin und ökonomische Rahmenbedingungen.

BACKGROUND: Healthcare is increasingly influenced by economical constraints which can lead to ethical conflicts for surgeons. The aim of the study was to investigate the incidence of these conflicts and the coping strategies of surgeons. METHODS: A prospective, standardized staff survey in an academic pediatric surgical department was performed over a period of 4 weeks. The types of conflict and solution strategies were determined. The agreement with given statements was determined using a 5-point Likert scale. RESULTS: In 155 returned questionnaires 74 ethical conflicts were identified. Most conflicts concerned decisions relating to diagnosis-related groups (DRG) which were economically based. To resolve the ethical conflict surgeons decided to the detriment of patients in 73  % and to the economical benefit in 72 %. In 8  % a medical disadvantage for the patient was noted and in 62  % a disadvantage for patient comfort was seen. Surgeons were highly dissatisfied with the conflict solutions (2.3/5). CONCLUSIONS: Economical considerations cause ethical conflicts in the daily routine in pediatric surgery. Decisions are made to the benefit of the hospital and cause a decrease in patient comfort. Political solutions for this problem are required in the interest of all those involved.

[Surgery on the fast track--"fast track" concepts in abdominal-/pediatric surgery and urology]. / Operative Medizin auf der Schnell- oder Uberholspur--"Fast Track" Konzepte in Chirurgie, Kinderchirurgie und Urologie.

In surgical medicine there are traditions, myths, rites and dogmas which define concepts of treatment and strategies. Upheld and passed on without being examined or confirmed in further studies, these concepts and strategies include preoperative intestinal lavage and fasting, postoperative long-term drainage, tubes und catheters, long-term relaxation of the intestine after abdominal surgery or immobilisation for some days. New techniques and procedures in surgery and anaesthesia, including postoperative pain management like laparoscopic surgery and partial anaesthesia, reduce the need for surgery and minimize morbidity of treatment. For more than ten years now, the Copenhagen abdominal surgeon Henrik Kehlet and his team have systematically dealt with the question of how to reduce perioperative stress and improve postoperative conditions of recovery. The resulting concepts of an "enhanced recovery after surgery" (ERAS) seek to overcome handed-down myths und fix new clinical pathways. In current prospective studies of elective surgery, the clinical use of these fast track concepts have been confirmed in colon surgery, pediatric surgery and urology. Here, examples of some of these studies are discussed together with problems like general complications and length of stay, while aspects of insurance are also taken into consideration.

Cost analysis of laparoscopic cholecystectomy in children.

A detailed analysis of the hospital-related costs of laparoscopic cholecystectomy in children was performed. Data on 10 laparoscopic cholecystectomies were collected prospectively. Pre-, intra- and postoperative variables were assessed by standardized questionnaires. The hotel costs and costs for nursing, physicians, medicaments and equipment were calculated in detail. Reusable instruments were assumed to be used for 50 operations per year over 5 years and the costs for disposable instruments were calculated for comparison. In addition, the data of 10 children who underwent open cholecystectomy were analyzed retrospectively. The mean hospital costs for one laparoscopic cholecystectomy was 3685 DM. The costs for the operation itself represented 36.5% of the hospital costs and were mainly due to expenses for surgeons and nurses. The costs for laparoscopic equipment and instruments represented only 8.5% of the total costs. If an open procedure instead of a laparoscopic operation had been performed with a similar duration of hospital stay, the hospital costs would have been reduced by 425 DM (11.5%). In laparoscopic cholecystectomy the costs for medical treatment in addition to the operation were 32.8% of the total costs and were mainly due to expenses for nursing and physicians, which added up to 165 DM per day. The hotel costs represented 30.7% of the total costs and added another 189 DM per day. Therefore, potential savings in the operation theatre are limited and most effective savings may be achieved by shortening the hospital stay. The use of disposable instruments would have increased the costs by 844 DM and already 20 operations per year would have been cheaper performed with reusable compared to disposable instruments. Reusable instruments are recommended. Additional 60 minutes operating time cost 312 DM (5.20 DM/minute) and therefore, laparoscopic training courses for surgeons may be cost-effective in order to reduce the costs for training in the operation theatre.

Costs of Laparoscopic cholecystectomy. Analysis of potential savings.

Despite the growing acceptance of laparoscopic cholecystectomy the costs remain unclear. Therefore, a detailed cost analysis was performed to determine potential savings. As part of a continuing audit, data of 508 consecutive laparoscopic cholecystectomies have been prospectively collected. Pre-, intra-, and postoperative variables were assessed by standardized questionnaires. These data were used to estimate the average use of diagnostics, drug consumption, operation time, and hospital stay. In addition, costs for loss in income, "hotel services", diagnostic procedures, and for the operation itself were calculated in detail. The total costs for a standard laparoscopic cholecystectomy were 3,395 deutsche marks (DM). The costs for the operation itself represented 19%, "hotel services" and medical treatment except the operation such as nursing, visits, or diagnostic procedures represented 47%, and the loss of income another 33% of the total costs. Thus, most effective savings may be achieved by shortening the hospital stay and the time of inability to work. However, each additional 30 min of operating time costed 146 DM (4.88 DM/min) and an "ideal" operation performed within 40 mins and with a 3-day hospital stay would save 20% of the total and 31% of the hospital costs. An increase in the number of operations per year would not have a relevant impact on the cost. Disposable instruments would have increased the costs by 1,118 DM (33%). The costs for cleaning, packing, and disposal were only marginal. Reusable instruments were not related to any disadvantage either to the patients or to the staff.(ABSTRACT TRUNCATED AT 250 WORDS)

[Do costs decide? Disposable or reusable instruments in laparoscopic cholecystectomy?]. / Entscheiden die Kosten? Einweg- oder wiederverwendbare Instrumente bei der laparoskopischen Cholecystektomie?

UNLABELLED: Laparoscopic cholecystectomy requires new and specially designed instruments. Both, disposable and reusable instruments are available and frequently used. The purpose of this analysis was to compare these instruments with regard to safety and costs. A complete and detailed calculation comprising all cost components was performed using data from 534 patients. SAFETY of the procedure was assessed by the documentation of all events during and after laparoscopic cholecystectomy in 1000 consecutive patients. COSTS: A standard operation with reusable instruments costs DM 3395. One third of these costs are non-hospital costs. Every postoperative day in hospital adds DM 234.44, every minute of operation time adds DM 4.88. Using a complete of disposable instruments causes an increase in total costs of DM 1117, which mainly results from the costs of the instruments themselves. SAFETY: Among 1000 operations all performed with reusable instruments, 82.3% were uneventful for the patient. The wound infection rate was 2.3%. Until today no injuries of the staff caused by these instruments were observed. These findings demonstrate that reusable instruments are safe and cost-effective.

Technology assessment of endoscopic surgery.

Endoscopic surgery is considered a milestone in the evolution of surgical technique in nearly all fields of surgery. However, the inappropriate use of the new technology in medicine has also been heavily criticised. Systematic technology assessment of endoscopic surgical techniques is mandatory to prove the real benefits and complications, so defining the indications for their appropriate use. This article describes methods of technology assessment suitable for endoscopic techniques with emphasis on relevant endpoints for surgeons and patients. The general stages of a comprehensive technology assessment include: 1. feasibility (safety and technical performance) 2. efficacy (patient benefits in pioneering places) 3. effectiveness (patient benefits in average hospitals in the community as a whole) and 4. economic evaluation (cost-benefit analyses). We used the example of laparoscopic cholecystectomy to describe the methods of technology assessment. A cohort study on 500 patients revealed that laparoscopic cholecystectomy is as safe as the conventional standard open technique. The results on efficacy strongly support the hypothesis of more comfort and less trauma with the endoscopic technique. Major endpoints evaluated were postoperative pain, convalescence, fatigue and quality of life. Data on effectiveness and economics are still in a "premature" state and should be the subject of further analyses. It is concluded, that other disciplines such as neurosurgery should evaluate their endoscopic surgical techniques according to the rules of technology assessment outlined in this paper.

[Patient-controlled analgesia (PCA) for postoperative pain relief. A prospective observational study for evaluating the technology in a ward routine]. / Patientenkontrollierte Analgesie (PCA) zur postoperativen Schmerztherapie. Eine prospektive Beobachtungsstudie zur Technologiebewertung im Stationsbetrieb.

Patient-controlled analgesia (PCA) is rarely used on surgical wards despite described advantages of this method as compared to conventional techniques. Uncertainties in patient selection and insufficient evaluation of this technique may explain these circumstances. The aim of our study was to evaluate PCA on general surgery and traumatology wards by means of standardized criteria for technology assessment (i.e. safety, practicability, benefit for patients and medical staff) and the efficacy of pain relief. In a prospective study we investigated 120 patients. In phase I, we performed analgesic therapy with tramadol/metamizol (50 ASA status I-IV patients). In phase II, piritramid had been applied to 70 ASA status I-II patients after an intermediate analysis of phase I. In 7% of the patients technical problems led to an early interruption even at the end of the study period. There were, however, no incidents which caused vital problems for the patients. A mean postoperative pain level of 55 visual analogue scale points (0-100 point scale) was achieved with tramadol/metamizol. PCA was stopped in 16% of the patients due to the occurrence of nausea or vomiting and in two patients due to insufficient pain relief. The use of piritramid in phase II led to lower pain levels and no interruptions of PCA because of ineffectivity or nausea/vomiting.(ABSTRACT TRUNCATED AT 250 WORDS)

Laparoscopic surgery in children and adolescents with suspected appendicitis: results of medical technology assessment.

Laparoscopy has been performed in 43 patients aged up to 18 years with suspected appendicitis; 20 were children 8-15 years and 23 adolescents 16-18 years of age. Diagnostic laparoscopy was successful in 36 (84%) patients; in 7 (16%) subsequent laparotomy was necessary to establish the diagnosis, in 4 (9%) because the appendix was not visualized. Laparoscopic appendectomy was done in 33 (77%) patients, additional laparoscopic adhesiolysis in four and inversion of a diverticulum in one. Changing to laparotomy during the laparoscopic operation was necessary in one patient because of a technical problem and in another because of bleeding of the appendicular artery. Laparoscopy was totally free of complications in 33 (77%) patients; another 9 (21%) had surgical or technical problems without negative outcome for the patient. In one (2%) patient a wound infection led to a negative outcome; there were no other laparoscopy-related events. The mean intensity of pain on the first day after laparoscopic appendectomy was 31 points (Visual Analogue Scale with 100 points) and decreased to nearly zero on the third day; 37% of patients needed opioids on the first and none on the third day. There was no statistical difference for pain intensity and consumption of analgesics after appendectomy via laparoscopy versus laparotomy. We conclude that diagnostic and therapeutic laparoscopy in children and adolescents with suspected appendicitis is a safe and effective procedure.

[Routine gastroscopy before laparoscopic cholecystectomy: evaluation of the technology in 376 patients]. / Routine-Gastroskopie vor laparoskopischer Cholezystektomie: Technologiebewertung bei 376 Patienten.

We performed endoscopy of the upper digestive tract in 376 patients before elective laparoscopic cholecystectomy. Abnormalities were found in 60 (15.9%); 14 patients had peptic ulcers, 15 gastric erosions, and 11 oesophagitis. Because of endoscopic findings 30 patients were treated medically and 2 by endoscopic polypectomy. Endoscopy lead us to cancel cholecystectomy in 4 patients; in 2 the complaints have persisted. Patients with abnormal endoscopic findings showed few significant differences in 40 variables (history and symptoms) compared with patients with normal findings. The incidence of ulcers, erosions or oesophagitis in patients over 72 years of age without loss of weight was 28.6%, compared with an overall incidence of 10.6%. Endoscopy confined to this group of patients, however, would have shown only 15% of all lesions. Consequently these predictors for endoscopic abnormalities had no practical benefit. Technology assessment according to the criteria of Fineberg et al. showed a health improvement for only 2 patients (0.5%). We conclude that routine endoscopy before laparoscopic cholecystectomy is not clinically useful in patients with symptomatic gallstone disease. This is exclusively related to patients with typical gallstone symptoms according to our definition.