[The impact of preoperative classification of expected intraoperative difficulties. A multicenter study]. / Stellenwert einer präoperativen Klassifikation erwarteter intraoperativer Schwierigkeiten : Eine multizentrische Studie.

BACKGROUND: This study examined the validity of the classification of intraoperative difficulties and its usefulness in surgical practice. MATERIAL AND METHODS: Data on general surgical patients were collected in four German hospitals within a multicentre validation study. Before and immediately after surgery, the operating surgeon rated the relative difficulty of the operation using a score of 1 (easy), 2 (not easy), 3 (difficult) and 4 (very difficult). Data on the duration of surgery and on the occurrence of intraoperative and postoperative complications were collected. Multivariate regression models were constructed to examine whether different clinical variables and the surgeon's preoperative assessment of surgical difficulty increased the power of the prognostic model. The R(2) statistics, which describe explained variance (EV) as a percentage was used to compare regression models. RESULTS: From July 2010 to August 2011 overall 500 patients were analyzed. Most patients were classified as being ideal (30 %) or relatively ideal (49 %) candidates for surgery. Preoperative and postoperative classification results were identical in 64 % of patients and were partly determined by classical risk factors (ASA score, number of previous surgeries, type of surgery, body mass index and gender). The addition of the surgeon's risk estimation to the multivariate models improved the prediction of duration of surgery (from 41.4% to 45.5 % EV), complications (from 22.5% to 24.5 % EV) and length of stay (from 32.6% to 34.5 % EV). CONCLUSIONS: The classification of intraoperative difficulty can be applicable in surgical daily practice in terms of surgical decision-making in difficult intraoperative situations as well as in operating room management. It could also be useful for other surgical disciplines.

[Organization of pain therapy in surgery--comparison of acute pain service and alternative concepts]. / Organisation der Schmerztherapie in der Chirurgie. Akutschmerzdienst und alternative Möglichkeiten im Vergleich.

An acute pain service done by surgeons is one possibility for organizing pain therapy in surgical wards. To do this successfully, some preconditions must be kept in mind, such as 24-h presence, an integrated system of documentation, and teamwork between medical and nursing staff. Comparison of differently structured pain therapy in three different hospitals (with and without acute pain service) showed high levels of patient satisfaction with the pain therapies in all three hospitals. One of the preconditions for effective pain therapy in surgery is to formulate a concept which takes into account the specific situation of each hospital.

[Psoas abscesses. Genesis, diagnosis, and therapy]. / Psoasabszesse. Entstehung, Diagnostik, Therapie.

BACKGROUND: A psoas abscess is a rarely encountered entity with various etiologies and nonspecific clinical presentation, frequently resulting in delayed diagnosis, increased morbidity, and prolonged or recurrent hospitalization. PATIENTS AND METHODS: Between January 1996 and January 2002 we treated ten patients (approximately 54.8, 5 males,5 females). These cases were analyzed retrospectively relative to a review of the literature. RESULTS: CT scanning was decisive in the final diagnosis of psoas abscess. Primary psoas abscess occurred in four cases and six patients had secondary abscesses. In all except one case, the psoas abscess was located on the right side. The causes of primary abscesses were retroperitoneal perforated appendicitis, paravertebral injections for lumboischialgia, Pott's disease, and repeated intravenous drug application in the groin. Five patients underwent retroperitoneal open drainage and four patients CT-guided drainage. One patient with retroperitoneal perforated appendicitis was treated by laparotomy. Staphylococcus aureus, Bacteroides fragilis, and Escherichia coli were the most common infective agents. There was no postoperative mortality and no cases of abscess recurred. CONCLUSIONS: CT scan is a diagnostic "gold standard" for psoas abscess. CT-guided drainage is the method of first choice, but is not possible in all cases. Open retroperitoneal drainage is a standard method of treatment. Postoperative antibiotic therapy is obligatory and should be adapted individually.

Laparoscopic gastric bypass for morbid obesity with linear gastroenterostomy.

BACKGROUND: Laparoscopic gastric bypass (LGBP) is a well-established procedure for the surgical management of morbid obesity. Most surgeons create the gastroenteral anastomosis by using the circular EEA stapler. We describe an alternative laparoscopic anastomotic technique using the EndoGIA linear stapling device. METHODS: The stomach was proximally transected with a linear stapler (45 mm, Endo-GIA) to create a 15 to 20 ml pouch. Next, an antecolic Roux-en-Y gastroenterostomy was performed, using the 45 mm Endo-GIA. The proximal loop of the intestine was then separated from the anastomotic site by the Endo-GIA. Finally, the Endo-GIA was used for the intraabdominal creation of a side-to-side enteroenterostomy. RESULTS: Between June and August 2001, 5 patients with mean BMI 56.7 kg/m(2)+/-7.3 underwent LGBP. All patients were seen 6 months post-surgery. Operating time was 7.5 and 6.5 hours for the first 2 operations, but was under 4.5 h for the next 3 cases. 1 patient suffered from perioperative hypoxia leading to long-term artificial respiration. 6 weeks after surgery, 1 patient developed obstruction due to torsion of the enteroenterostomy and required open revision. The 3 remaining patients made an uneventful recovery. All patients lost considerable weight (mean 36.5 kg; [range 32 to 45] after 6 months). No stenosis or anastomotic leakage was noted. CONCLUSIONS: A linear stapled anastomosis is an alternative to the use of the circular stapler.

Port function after laparoscopic adjustable gastric banding for morbid obesity.

BACKGROUND: Laparoscopic adjustable gastric banding (LGB) has gained wide popularity, but information on port function is limited. METHODS: In a prospective nonrandomized study, we analyzed port function and related symptoms in 50 consecutive patients with severe obesity. All patients underwent LGP in a five trocar technique. In 11 patients, the port was placed subcutaneously in the subxiphoid region. In 39 patients, the port was implanted in the left upper abdomen. Mean duration of follow-up was 2.8 years. RESULTS: Patients (12 males and 38 females) had an initial body mass index (BMI) of 47.1 kg/m2. Puncturing the subxiphoidal port was without problems in all 11 patients. However, seven women reported pain and inconvenience when wearing a brassiere. Two underwent port reimplantation in the left upper abdomen (one due to infection; one due to pain). Among the 39 patients with abdominal port implantation, nine patients required port correction (two of them twice). The causes were port dislocation (four cases), difficult puncturing (three), tube leakage (three), and infection (one). CONCLUSION: The high number of complications suggests that the port is the Achilles' heel of LGB. Ports at the subxiphoid site were easier to puncture, but frequently caused pain in female patients.

[Reliable and unreliable health measures in surgery]. / Sinnvolle und nicht sinnvolle Hygienemassnahmen in der Chirurgie.

Despite high standards in theatre design, surgical skills and antibiotic prophylaxis, surgical site infections are still a major complication in modern surgery. After urinary tract infections and lower respiratory tract infections they account for 15.8% of all nosocomial infections in Germany [31]. Causes are multiple and only partially exogenous. The single most important (exogenous) risk factor is the technical skill of the surgeon. Not all surgical site infections are therefore preventable by infection control measures alone. Useful and useless infection control measures will be evaluated critically in the following review according to data in the literature.

[The role of preoperative oesophageal manometry in patients with gastro-oesophageal reflux disease]. / Stellenwert der stationären Osophagusdurchzugsmanometrie zur präoperativen Abklärung von Patienten mit gastro-ösophagealer Refluxkrankheit.

BACKGROUND: Oesophageal manometry has become a standard investigation in the management of functional disorders of the oesophagus. However, the importance of the various manometry parameters for the surgical management of patients with gastro-oesophageal reflux disease (GERD) has not yet been studied adequately. AIM: This study examined the importance of manometric findings on surgical treatment results in patients with GERD. PATIENTS AND METHODS: Between January 1995 and January 2000, 123 consecutively referred patients with GERD symptoms were studied. Ninety-seven of these (52 women and 45 men, mean age 48 years) underwent Nissen fundoplication in conventional or laparoscopic technique. Preoperatively, each patient received stationary oesophageal manometry with a water perfusion catheter, gastroduodenoscopy and 24h-pH-metry of the oesophagus. Independent of manometric results, patients received 360 degrees fundoplicatio with 2 cm cuff ("floppy Nissen"). RESULTS: Eighty-five of the 97 patients (88 %) had an incompetent lower oesophageal sphincter. Hypomotility was diagnosed in 17 (18 %). Amotile achalasia and diffuse oesophageal spasms were seen in two and one patient, respectively, who were not operated on. Follow-up data were available for 92 % of patients (mean follow-up time 1.8 years). Five and 8 patients (1 and 2 of these with hypomotility) postoperatively developed persistent dysphagia and GERD recurrence, respectively (relative risks 1.2 and 1.6). Two patients (one with hypomotility) required surgical revision. CONCLUSIONS: Preoperative oesophageal manometry in GERD patients is useful only for determining the position of the upper boundary of the lower oesophageal sphincter and for ruling out specific motility disorders. In patients with oesophageal hypomotility, "floppy Nissen" fundoplicatio can be performed without an excess risk of dysphagia.

A rare complication of laparoscopic adjustable gastric banding.

The most common complications of laparoscopic gastric banding (LGB) are band dislocation, port problems, and leakage in the band system. We present a case of an aneurysmal dilatation of the balloon portion of the band by filling as a rare complication of LGB. A 53-year-old male patient with morbid obesity (body mass index 40 kg/m2) was treated with LGB (adjustable Bioenterics gastric band). Six months after the operation there was no evidence of weight reduction. X-ray examination showed the band to be in the correct position. The port punction revealed no spontaneous fluid loss. The contrast filling of band demonstrated no signs of leakage but there was an abnormal dilatation of one part of the balloon. Only one filling segment of balloon was dilatated and the rest was empty. Two and a half years after the initial operation, we carried out laparoscopic band exchange. Six weeks later, the band was adjusted with 2 ml saline, and the patient reported successful reduction of food volume. He had lost 18 kg 3 months postoperatively. We conclude that band function requires careful intraoperative monitoring. In patients who do not lose weight after gastric restriction surgery, uncommon complications must also be considered.

[Benign peptic stricture of the middle third of the esophagus]. / Benigne peptische Striktur des mittleren Osophagusdrittel.

By means of a case report classification, etiology and pathogenesis of benign esophageal strictures are discussed. In the presented case an endobrachyesophagus with peptic stricture of the middle third of the esophagus was found. The most common conservative treatment consists of esophageal bouginage combined with long-term medication of proton pump inhibitors as was also done in this case. Depending on the physical status of the patient surgical treatment is given if repeated bouginage of the stricture during at least 3 months becomes necessary. Resection of the stricture or antireflux surgery in combination with bouginage of the stricture are current surgical options.

Randomized clinical trial of suture repair, polypropylene mesh or autodermal hernioplasty for incisional hernia.

BACKGROUND: Since conventional suture repair for incisional hernia is associated with high recurrence rates, alloplastic and autoplastic prosthetic techniques have been suggested. METHODS: In a randomized trial, 160 patients with simple or complex hernias underwent either suture repair, autodermal skin graft or onlay polypropylene mesh repair. Suture repair was not done in complex hernias. This report concerns a planned interim analysis. RESULTS: At mean follow-up of 16 months, there were 17 hernia recurrences that were distributed similarly between the surgical techniques. There were fewer infectious complications after suture repair (three of 33 patients) than after skin graft or mesh repair (seven of 39 and five of 28 for simple hernias; seven of 31 and ten of 29 respectively for complex hernias) (P not significant). The severity of infections after polypropylene mesh implantation prompted the trial committee to discontinue the study. No differences were noted in duration of stay in hospital and quality of life. However, pain was significantly more frequent after polypropylene mesh repair (pooled risk ratio 2.9 and 1.8 at 6 weeks and 1 year respectively). CONCLUSION: Suture repair was safe for small incisional hernias. Both autoplastic and alloplastic hernia repair yielded comparably low recurrence rates, but led to a high rate of wound infection.

[Percutaneous endoscopic gastrostomy (PEG). Course, nutrition and care in 233 consecutive patients]. / Die perkutane endoskopische Gastrostomie (PEG). Verlauf, Ernährung und Pflege bei 233 konsekutiven Patienten.

AIM: To evaluate the course, nutrition and care of PEG tubes on the basis of data collected from 233 consecutive patients. PATIENTS AND METHOD: Between 1.1.1990 and 31.3.1996, a total of 243 PEG tubes were implanted in 233 patients--56.5% male and 43.5% female--with an average age of 66.2 years. 57.3% had neurological, and 19.4% neurosurgical, diseases, 11.2% suffered polytraumatization or severe burns, and 8.2% had a malignancy. Patients stayed with the implanted tube on average 153 days, with neurological patients leading the field at 189 days. RESULTS: The overall complication rate was 14.5%, with the most common complication being local infection, which occurred in 5.4% of the cases. Severe complications were seen in 1.2%. One patient developed a necrotizing fasciltis, and in two others, migration of the tube was observed. 52.2% of the patients died with the tube still in place. In 33.6%, the PEG tube was removed after a mean of 82.7 days, when adequate oral nutrition again became possible. CONCLUSION: In this study, PEG proved an effective method for enteral nutrition over the middle-to-long-term in multimorbid and intensive care patients, as well as in those with malignant disease.

Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol for a controlled clinical trial developed by consensus of an international study group. Part two: design of the study.

GENERAL DESIGN: Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). This part describes the design of the randomised, placebo controlled, double-blinded, single-centre study performed at an university hospital (n = 40 patients for each group). OBJECTIVE: The trial design includes the following elements for a prototype protocol: * The study population is restricted to patients with colorectal cancer, including a left sided resection and an increased perioperative risk (ASA 3 and 4). * Patients are allocated by random to the control or treatment group. * The double blinding strategy of the trial is assessed by psychometric indices. * An endpoint construct with quality of life (EORTC QLQ-C30) and a recovery index (modified Mc Peek index) are used as primary endpoints. Qualitative analysis of clinical relevance of the endpoints is performed by both patients and doctors. * Statistical analysis uses an area under the curve (AUC) model for improvement of quality of life on leaving hospital and two and six months after operation. A confirmatory statistical model with quality of life as the first primary endpoint in the hierarchic test procedure is used. Expectations of patients and surgeons and the negative affect are analysed by social psychological scales. CONCLUSION: This study design differs from other trials on preoperative prophylaxis and postoperative recovery, and has been developed to try a new concept and avoid previous failures.

Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol of a controlled clinical trial developed by consensus of an international study group. Part one: rationale and hypothesis.

GENERAL DESIGN: Presentation of a novel study protocol to evalue the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). The rationale and hypothesis are presented in this part of the protocol of the randomised, placebo controlled, double-blinded, single-centre study performed at an university hospital (n = 40 patients for each group). OBJECTIVE: Part one of this protocol describes the concepts of three major sections of the study: Definition of optimum and sub-optimal recovery after operation. Recovery, as an outcome, is not a simple univariate endpoint, but a complex construction of mechanistic variables (i. e. death, complications and health status assessed by the surgeon), quality of life expressed by the patient, and finally a weighted outcome judgement by both the patient and the surgeon (true endpoint). Its conventional early assessment within 14-28 days is artificial: longer periods (such as 6 months) are needed for the patient to state: "I am now as well as I was before". Identification of suitable target patients: the use of biological response modifiers (immune modulators) in addition to traditional prophylaxes (i. e. antibiotics, heparin, volume substitutes) may improve postoperative outcome in appropriate selected patients with reduced host defence and increased immunological stress response, but these have to be defined. Patients classified as ASA 3 and 4 (American Society for Anaesthesiologists) and with colorectal cancer will be studied to prove this hypothesis. Choice of biological response modifier: Filgrastim has been chosen as an example of a biological response modifier because it was effective in a new study type, clinic-modelling randomised trials in rodents, and has shown promise in some clinical trials for indications other than preoperative prophylaxis. It has also enhanced host defence and has been anti-inflammatory in basic research. CONCLUSION: The following hypothesis will be tested in patients with operations for colorectal cancer and increased preoperative risk (ASA 3 and 4): is the outcome as evaluated by the hermeneutic endpoint (quality of life expressed by the patient) and mechanistic endpoints (mortality rate, complication rate, relative hospital stay, assessed by the doctor) improved in the group receiving filgrastim prophylaxis in comparison with the placebo group? Quality of life will be the first primary endpoint in the hierarchical, statistical testing of confirmatory analysis.

Biomechanical and morphological types of the linea alba and its possible role in the pathogenesis of midline incisional hernia.

OBJECTIVE: To review the tensile strength of the different histological types of fibres in the linea alba and correlate the anatomical features of the anterior abdominal wall with the tensile strength of the linea alba to see whether the tensile strength of the linea alba might contribute to the development of midline incisional hernias. DESIGN: Laboratory study. SETTING: University hospital, Germany. SUBJECTS: 46 cadavers in part one, and 9 freshly frozen and 38 formalin-fixed cadavers in part two. INTERVENTIONS: In the first part of the study the histological examination was by binocular dissection microscopy, magnification x10, but this was not sufficiently reproducible so in the second part we used an Olympus BX50 microscope, magnification x20, and Optimas 5.22 picture processing software. Tensile strength was measured using a Loosenhausen ZHP 1-6 tensiometer. MAIN OUTCOME MEASURES: Correlation between anatomical features and tensile strength. RESULTS: The method used in part one of the study failed to differentiate between the three types of fibres in the linea alba (weak, intermediate, and compact). In the second part of the study we found that the fibres were irregular, with no systematic crossing of the fibres of the aponeurosis. There was a significant correlation between the thickness and density of fibres in the linea alba and its tensile strength (r = 0.9). The thickness of fibres ranged from 21.9-38.2 microm and the density from 48% to 90%. The tensile strength ranged from 3-25 kp. CONCLUSION: A combination of low density and thin fibres in the linea alba could be a predisposing factor for development of midline incisional hernias

[How much pain is tolerable? Target expectations of surgical patients for pain therapy]. / Wieviel Schmerz ist erträglich? Zielvorstellungen chirurgischer Patienten für die Schmerztherapie.

INTRODUCTION: Sufficient pain treatment is part of surgical therapy. One popular method of pain control is patient-controlled analgesia (PCA), which allows the patients to apply small doses of analgesics intravenously via a pump. Patient involvement in PCA requires an exact assessment of the patient's expectations as to the treatment of pain. METHODS: In a prospective study the patient's expectations of pain therapy were observed with respect to their disease and the actual intensity of pain during activities measured with a visual analogue scale (VAS). Fifty-three patients were involved, using a pain questionnaire. Healthy nursing staff (n = 44) served as a control group. RESULTS: Patients with benign (n = 29) or malignant (n = 24) disease showed no significant difference in the VAS scores accepted from patients as aim of successful pain therapy (25 points in the conservatively treated group and 27 points in the group of the operatively treated patients with malignant disease, 21 points in the operatively treated group with benign disease, and 18 points in the group suffering from chronic pain of benign causes). The aims for pain therapy showed no correlation with the actually felt pain intensity during movement. The control group of healthy nursing staff felt less actual pain during movement, but their expectations for sufficient pain treatment were not significantly different from the study patients (VAS 25.4 points).

[Risk analysis in surgery. A method of increasing effectiveness and efficiency: a neglected method]. / Risikoanalyse in der Chirurgie. Eine Methode zur Steigerung von Effektivität und Effizienz--eine vernachlässigte Methode.

UNLABELLED: The estimation of risk should be an essential prerequisite for the choice of the correct surgical therapy and also for assessment of the quality of surgical care. The fact is, that many people talk about "risk" but have the wrong idea about this remarkable concept. Too often minutely detailed enumeration of negative events (complications) is mistaken for risk. Risk is the probability that something negative will happen. It is also a fact that risk is always regarded as negative. Another fact is that risk in medicine mostly--or only--describes morbidity and mortality. Even though this is correct and important, it is not enough! Today, risk must include the probability of a therapy option not working, or even the risk of perversion of the therapy intention! Determination of a risk factor is time-consuming. It is a typical example for clinical research. Proceeding stepwise is may-be helpful. I propose seven steps: Step 1 demands that the circumstances, facts, variables like negative events, ability to cooperate, mortality, severeness of sickness, social circumstances, etc. be clarified. Step 2 means collecting and compiling these circumstances assumed to be clinically relevant All sources of information are good, but better is a prospective data collection. Step 3 defines the individual surgical situation, and from this the different circumstances, which could be risk factors. This is regarded as development of hypothesis. In step 4 the probability is determined with which a special condition or a group of circumstances could become a clinically relevant risk factor. This is done in the clinical experiment with the aid of the mathematical models known today, but also with the experience and intuition of the surgeon. In step 5 the individual clinical situation can be determined according to the significance of the risk factors (ranking). Step 6 is intended for handling the known risk factors. How to proceed with the risk factor within the decision finding process at the surgical intervention? Step 7 is the all decisive step. It should supply the unequivocal information as to whether risk analysis in toto will bring any benefit for surgery--even more importantly, for the individual patient at a certain time. There is evidence (external) that the correct handling of the risk analysis brings a significant effect or benefit in surgery, but it still has its limits. It is a fact that risk analysis with the methods used nowadays has an advantage for group analyses, but ist limits are tight for the individual patient. This is especially true for the scores established and used for this. With the risk analysis the decisive risk factors can be recognized and determined and put into order according to their different effect. Whether this fact has a benefit in surgery or even for the individual patient is still without unknown. There is evidence that comparing the quality of surgical treatments in individual clinics without risk analysis is almost naive! This is the case for which risk analysis has proved to be the best! Risk analysis is so far unable to predict the risk of a surgical therapy for an individual patient with sufficient certainty. With a value of 70% certainty, risk analysis is as good--or as bad--as the experienced surgeon for this decisive question. CONCLUSION: Risk analysis has not yet given enough proof of its effectiveness. The method is time consuming and up to now only successful for assessment of groups. Comparison of surgical quality in different clinics is naive without risk analysis. Here its importance has been proved. The risk analyses practised so far have no chance when dealing with the individual patient. It can be recognized that the surgeon is a risk factor. However, in the complex system of different circumstances and mechanisms of a surgical care, he is only one factor even though an important one. Risk analysis is an aspect of clinical research and demands more consideration.

Prospective double-blind randomised study of a new regimen of pre-emptive analgesia for inguinal hernia repair: evaluation of postoperative pain course.

OBJECTIVE: To evaluate the effectiveness of a new regimen of pre-emptive analgesia on the development of postoperative pain after inguinal hernia repair. DESIGN: Prospective, double-blind, randomised study. SETTING: University Hospital, Germany. SUBJECTS: 70 consecutive patients who had primary unilateral inguinal hernia repairs. INTERVENTIONS: A new regimen of pre-emptive analgesia with bupivacaine that was infiltrated preoperatively, intraoperatively, and postoperatively was tested. The control group were given saline infiltrations at the same times. Pain was measured up to postoperative day 30 using the visual analogue scale (VAS), the verbal rating scale (VRS), and by recording patient-controlled use of ibuprofen suppositories. RESULTS: Pain was significantly less in the pre-emptive analgesia group than in the control group during the first 10 days postoperatively as assessed by VAS and VRS (p < 0.05). Analgesic consumption was also significantly reduced in the pre-emptive analgesia group (p < 0.05). Multivariate analysis showed that bupivacaine infiltration (pre-emptive analgesia) was associated with significantly less postoperative pain (p < 0.0001). CONCLUSION: This regimen of pre-emptive analgesia is an effective and safe method of reducing postoperative pain and analgesic consumption after inguinal hernia repair.