Prevention of anastomotic leak in rectal cancer surgery with local antibiotic decontamination: a prospective, randomized, double-blind, placebo-controlled single center trial.

PURPOSE: Anastomotic leak and other infectious complications are septic complications of rectal cancer surgery caused by bacteria. Data from registry analysis show a beneficial effect of local antimicrobial administration on anastomotic leaks, but data are inconsistent in recent clinical trials. Therefore, our aim was to study the efficacy of topical antibiotic treatment on the incidence of anastomotic leaks in rectal cancer surgery. METHODS: A prospective, randomized, double-blind and placebo-controlled, single center trial was conducted. Patients received either placebo and amphotericin B or decontamination with polymyxin B, tobramycin, vancomycin, and amphotericin B four times per day starting the day before surgery until postoperative day 7. If a protective ileostomy was created, a catheter was placed transanally and the medication was administered locally to the anastomotic site. All patients received an intravenous perioperative antibiotic prophylaxis. RESULTS: The trial had to be stopped for ethical reasons after first interim analysis with 80 patients instead of the initially planned 280 patients. Of the 40 patients randomized to receive placebo, eight (20%) developed anastomotic leak compared to only 2 (5%) in the treatment group of 40 patients (decontamination) with significant difference in the χ2 test (p = 0.0425). Twenty percent of the placebo group and 12.5% in the treatment group developed infectious complications not associated with anastomotic leak (p = 0.5312). One patient (2.5%) in the placebo group died (p = 0.3141). CONCLUSION: Local decontamination with polymyxin, tobramycin, vancomycin, and amphotericin B is safe and effective in the prevention of anastomotic leak in rectal cancer surgery.

[Observations on the use of TachoSil® in cholecystectomy - a multicentre, prospective, single-arm cohort study]. / Anwendungsbeobachtung zu TachoSil® bei der Cholezystektomie - Eine multizentrische prospektive einarmige Kohortenstudie.

An observational study on TachoSil® as used in the gall bladder surgery and an analysis of the experience obtained by employing a haemostatic agent in one of the most common procedures in general and visceral surgery have been carried out. The aim of the study was to answer the following questions. When is TachoSil® in routine use? Does TachoSil® have a positive effect on the perioperative course? Is TachoSil® suitable for the routine application in difficult cholecystectomy? In the present single-arm prospective cohort study only departments with specialisation in general and visceral surgery of 40 clinics in Germany participated. Although 500 planned interventions were to be documented in 2007, only 169 operations were actually reported. The numerical results were statistically analysed and summarised. Before the operation was carried out a classification according to the bleeding history was performed. The surgery was performed in the open, laparoscopic or converted modes. During the intervention the surgeon decided about the application of TachoSil® on the basis of a risk index. According to the collected data, it was significant that TachoSil® was used more frequently when either a cholecystectomy was performed in the open mode or on conversion from laparoscopic to the open mode. Also it was significant that TachoSil® was chosen when a patient had a defect in blood coagulation or when the cholecystectomy was part of a multivisceral resection. 59.7% of the patients where TachoSil® was used had a known risk of haemorrage. 12.4 % of the patients where TachoSil was used underwent at least one intervention to compensate intraoperative blood loss before (10.1 % blood transfusion, 4.7 % blood substitutes). In 97 % TachoSil® was used as a haemostatic agent, in 30.2 % it was chosen to prevent a biliary leak and in 11.24 % to augment vulnerable tissue (multiple answers possible). Concerning laparoscopic cholecystectomy, it was significant that the surgeons decided to take middle-sized patches (4.8 × 4.8 cm) more frequently. Only in 6 cases were the small-sized patches (3 × 2.5 cm) chosen. 90.5 % of the patches were placed in the liver bed. In 5.3 % of the cases the position was not documented. In 4.1 % the patch was placed upon the hepatoduodenal ligament or a suture of the bile duct. To conclude, in difficult cholecystectomies and cholecystectomies as part of multivisceral resection, the use of TachoSil® is an option for experts to secure the seam, to prevent a bile leakage and to control bleeding in the surgical areas.

[Inguinal hernia repair in TAPP technique in a day-case surgery setting - at what price?] / Ambulanter transabdomineller präperitonealer Leistenhernienverschluss (TAPP) ­ um welchen Preis?

BACKGROUND: TAPP surgery can be considered as a gold standard in inguinal hernia repair. Patients benefit of a faster reconvalescence and less pain compared to other techniques. TAPP surgery in Germany is performed in an in-patient setting routinely. However, according to European guidelines, inguinal hernia surgery should be considered as day-case surgery whenever possible. OBJECTIVES: The safety of day-case surgery was examined in relation to postoperative pain, complications, comorbidities, recurrent inguinal hernia and bilateral procedures. MATERIAL AND METHODS: In a retrospective, monocentric study we analyzed 522 elective inguinal hernia repairs using TAPP technique in a specialized hernia center. Supplemental data from Herniamed registry is analyzed. RESULTS: Parts of the procedures should be performed in an in-patient setting, whereas a much larger number of cases should be carried out as day-case surgeries. Logistic regression analyses show that "age", "bilateral procedures" and "comorbidities" affect the complication rate. "Age" and "recurrent inguinal hernia" are risk factors for an increased need for analgetic medication. Furthermore, we present an actual distribution of day-case vs. in-patient surgeries in inguinal hernia repair based on data from the Herniamed registry. CONCLUSION: A much larger part of procedures could safely be carried out as day-case surgeries. Based on a false incentive there is an incorrect steering in the German health system. These procedures cannot be carried out covering the costs as day-surgery cases. If there is no reevaluation of the proceeds of these procedures in a day-case surgery setting, the reasonable quality in treatment is compromised especially in inguinal hernia surgery.

[Use of biological meshes in abdominal wall reconstruction. Results of a survey in Germany]. / Einsatz biologischer Netze bei der Bauchdeckenrekonstruktion. Ergebnisse einer Umfrage in Deutschland.

BACKGROUND: Surgical treatment of incisional hernia includes implantation of a mesh. The use of synthetic grafts in contaminated fields results in an increased risk of infection. In these cases a potential advantage is described for biological repair material. Evidence for this problem is lacking; therefore, we initiated a survey among surgeons in Germany concerning this question. MATERIAL AND METHOD: A survey concerning indications, experience and techniques of using synthetic and biological meshes was sent to 60 surgical departments. The emphasis of the survey was on the differentiation of clean and contaminated fields. RESULTS: The survey was answered by 42 %. The use of biological repair material was preferred in clean-contaminated, contaminated and soiled fields. Synthetic meshes were preferred in clean, rarely in clean-contaminated and not in contaminated or soiled situations. Primary suture repair was chosen in clean fields and barely in contaminated fields. For closure of giant hernias a component separation technique (CST) was favored by the majority of respondents. A single stage repair was preferred by most of the surgeons even in cases with simultaneous stoma takedown. A total of 72 % of the respondents were satisfied with the use of biological repair material, but the reimbursement was considered to be inappropriate. DISCUSSION: Although the response rate was low, this survey gives an idea of the attitude towards the use of synthetic and biological meshes. Biological repair material is favored for hernia repair in contaminated or soiled fields. The advantage of this choice is a one stage repair despite the contamination. As the results of this survey are not able to provide arguments for the use of different meshes this question should be further investigated with a randomized controlled trial.

A comparison of different techniques for liver resection: blunt dissection, ultrasonic aspirator and jet-cutter.

In a prospective study 116 patients underwent liver resection. Three different resection techniques, blunt dissection (n = 61), ultrasonic aspirator (CUSA) (n = 27) and jet-cutter (n = 28) were compared. Speed of resection, blood loss, transfusion rate, liver hilus clamping time and tissue damage were evaluated on the basis of area of transected liver surface. Liver resection with the jet-cutter was significantly faster with a resection time of 0.33 min/cm2 in comparison to blunt dissection (0.57 min/cm2) and CUSA (0.50 min/cm2) (P < 0.01) and associated with lower blood loss of 17.7 ml/cm2 (P < 0.01) than the other techniques (blunt dissection 32.5 ml/cm2, CUSA 24.3 ml/cm2). Tissue damage with respect to transaminases SGOT and SGPT was comparable to the other techniques. The jet-cutter is a promising new instrument in liver surgery.

Alleles of the alpha-1-antitrypsin phenotype in patients with aortic aneurysms.

OBJECTIVE: To examine the possible significance of homo- or heterozygous alpha-1-antitrypsin deficiency in the pathogenesis of aortic aneurysms (AA). DESIGN: Prospective investigation. SETTING: University hospital. PATIENTS: 300 controls representing the general population in our region of Southern Germany and 126 patients with aneurysmectomy and graft insertion. METHODS: The alpha-1-antitrypsin phenotype was determined by employing isoelectric focusing. Each patient was also evaluated for hypertension, lipometabolic dysfunction, smoking, hyperuricemia, and diabetes mellitus. MAIN OUTCOME MEASURES: The frequency and distribution of alpha-1-antitrypsin phenotypes and risk factors. RESULTS: 115 of 126 patients presented with one or several of the conventional risk factors: hypertension (61.5%), lipometabolic dysfunction (36.9%), smoking (58.4%), hyperuricemia (13.8%), or diabetes mellitus (6.9%). The following frequencies of alpha-1-antitrypsin phenotypes were determined: PiMM (82.5%), PiMV (4.7%), PiML (1.5%), PiMS (7.1%), PiSS (0.7%), PiMZ (3.0%). Indeed, when compared to the general population (control group) the percentage of the normal PiMM phenotypes was lower in the group of patients with AA (p<0.001). However, in our study this significant difference was not primarily due to the presence of patients homozygous or heterozygous for deficiency alleles PiMS, PiSS and PiMZ (p=0.0523) as has been previously reported, but rather to the high prevalence of the variants PiMV (p<0.005). CONCLUSIONS: Our study suggests that not only Pi-deficiency alleles, previously identified as being associated with AA, but also that Pi variants may play a pivotal role in the pathogenesis of AA.

Laparoscopic liver resection compared with conventional partial hepatectomy--a prospective analysis.

BACKGROUND/AIMS: Tumor size and location are the major influences on the practicality of a laparoscopic operation. Visual control of the operating field is important for isolation and ligation of blood vessels and bile ducts after selective liver dissection by suitable techniques such as the water-jet dissector. METHODOLOGY: We carried out laparoscopic liver resections with the Jet-Cutter in 17 patients. The results were compared to a control group of 17 closely matched patients undergoing conventional hepatic resection during the period of the study. In 1 patient, conversion of laparoscopic to an open operation was required. RESULTS: Early in our learning curve, the duration of operation and time for resection were significantly longer in the laparoscopic group. Following laparoscopic operation, patients were discharged from the hospital after a mean of 7.8+/-8.2 days; patients having undergone conventional operation were discharged after a mean of 11.6+/-12.8 days. CONCLUSIONS: Laparoscopic liver resection is technically feasible, but, at present, careful patient selection is required.

[Laparoscopic transperitoneal adrenalectomy]. / Die laparoskopische transperitoneale Adrenalektomie.

The laparoscopic transperitoneal adrenalectomy combines the advantages of the conventional transperitoneal approach with the well known advantages of minimally invasive surgery. The positive personal experience in 5 patients and the results of the literature are reported. According to these data we are dealing with a safe procedure requiring an acceptable operating time, little postoperative pain of short duration, fast recovery and a short postoperative in-hospital stay. Indications are benign non-hormone- as well as hormone-producing adrenal lesions. Until now there are no definitive size limitations. Malignant tumors should continue to be operated conventionally.

[Various techniques for laparoscopic small intestinal anastomosis. A preliminary report]. / Verschiedene Techniken für die laparoskopische Dünndarmanastomosierung. Eine vorläufige Mitteilung.

Three groups with n = 6 pigs were subjected to different techniques of endoscopic small bowel anastomosis. In Group I connection of the gut endings was done, using an all layer stapler-device, otherwise employed as hernia-stapler. Two thirds of the circumference became inverted, one third was everted. Anastomosis of Group II was done with the same stapler device, but all clips were set to evert the wound-endings. Group III consisted of triangularly shaped anastomosis, for which a linear stapler device was being used. All animals survived the investigation period (14 days) and were postmortally examined. Technical aspects and clinical results are being discussed.

[Laparoscopic single staple suture--initial clinical experiences]. / Laparoskopische Einzelklammernaht--erste klinische Erfahrungen.

Based on the results of our own animal experimental investigations, the first clinical employment of single titanium staples in the creation of suture lines on the gastrointestinal tract was carried out. These staple lines are most favorably adapted for laparoscopic use. First experiences with 10 staple lines, 6 of which were anastomoses, are reported. Neither insufficiencies nor stenoses were detected. Until now there are no long-term observations. The technique seems to allow open or laparoscopically the creation of standardized suture lines in any segment of the gastrointestinal tract.

[Experience with the transabdominal preperitoneal (TAPP) technique regarding recurrent hernia]. / Erfahrungen mit der laparoskopischen transabdominellen präperitonealen (TAPP) Technik bei Versorgung von "Rezidiv-Leisten-Hernien".

INTRODUCTION: It was our aim to evaluate the results of laparoscopic transabdominal preperitoneal hernia repair (TAPP) with regard to recurrent hernias treated in our department. METHODS: Included were 276 operations for first or subsequent recurrence of inguinal hernia previously treated with suture repair. All final repairs were carried out using the TAPP technique. The data were collected prospectively. The patients were examined 2 weeks and 1 year postoperatively. The rate of follow-up amounted to 78.1 % at 1 year after operation. RESULTS: Perioperative complications were monitored prospectively and divided into intraoperative, minor and major. The overall complication rate amounted to 9 %, major complications 5.3 %. The re-recurrence rate was 0.4 %. CONCLUSIONS: Because of the general advantages of laparoscopic surgery and the low recurrence rate we prefer laparoscopic hernioplasty using the TAPP technique.

[Is heterozygote alpha 1-antitrypsin deficiency a risk factor in the etiology of aortic aneurysm?]. / Ist ein heterozygoter Alpha-1-Antitrypsinmangel ein Risikofaktor in der Atiologie des Aortenaneurysmas?

A potential role of homozygous or heterozygous alpha-1-antitrypsin deficiency alleles Pi*Z or Pi*S in the pathogenesis of aortic aneurysms has been debated in recently published papers. Therefore, we have determined the alpha-1-antitrypsin phenotype in 103 patients with aortic aneurysms using isoelectric focusing. The vast majority of patients (92.2%) had one or more of the established risk factors: hypertension (65.0%), lipometabolic dysfunction (34.9%), smoking (65.0%), hyperuricemia (16.5%) or diabetes mellitus (8.7%). In our patients, the deficiency alleles Pi*Z and Pi*S were more frequent than in the general population of our region, but these differences did not reach statistical significance (PiMS 6.7 versus 3.4%, PiMZ 3.8 versus 2.5%, PiSS 0,9 versus 0.2%). Furthermore, the patients with heterozygous or homozygous antitrypsin deficiency had similar patterns of risk factors to those of the patients with normal phenotypes. In one patient we found a heterozygous PiMZ antitrypsin deficiency associated with Marfan's syndrome. These data do not support the results of recently published studies of fewer cases that suggest a higher prevalence of antitrypsin deficiency alleles in patients with aortic aneurysms. A heterozygous alpha-1-antitrypsin deficiency as a cause or predisposing factor for the development of aortic aneurysms appears to be of little or no importance.

[Cost savings by disinfection for prevention of surgical wound dehiscence after gastrectomy]. / Kostensenkung durch Dekontamination zur Prävention der Nahtinsuffizienz nach Gastrektomie.

The aim of this study was to examine the effect of decontamination as compared to placebo medication on post-gastrectomy treatment costs. The results of a prospective double-blind placebo-controlled multicenter trial indicate that perioperative i.v. prophylaxis with cefotaxim and topical decontamination with polymyxin B, tobramycin, vancomycin and amphotericin B from the day before surgery until the 7th postoperative day is most effective in the prevention of esophagojejunal anastomotic leakage following total gastrectomy. For the cost analysis, only patients who had been decontaminated according to the study protocol (n = 90) were compared to the non-decontaminated patients (n = 103). The esophagojejunal leakage rate was 10.6% in placebo patients (n = 103) and could be reduced significantly to 1.1% in decontaminated patients (n = 90, P = 0.0061; two-tailed Fisher's exact test). There was only one asymptomatic leakage detected on Gastrografin swallow. The pulmonary infection (P = 0.0173) and overall complication rates (p = 0.0238) were significantly reduced in the decontamination group as well. During the observation period, 9 (8.7%) patients in the placebo group and 3 (3.3%) in the decontaminated group died (P = n.s.). Patients were followed up for the initial 42 postoperative days and treatment costs were calculated for this time period only. The parameters compiled in the study pertaining to use of medical resources formed the basis for the determination of the postoperative treatment costs. These were the costs for decontaminating drugs, intravenous antibiotics, reoperations and non-surgical reinterventions as well as daily treatment costs of the general ward, the intensive care unit (ICU) and rehabilitation. The average costs per patient in the placebo group amounted to DM 20,000 while the costs for decontaminated patients were only DM 16,200, which was due to a significantly lower number of patients requiring treatment in the ICU (P = 0.0082), significantly fewer patients requiring i.v. antibiotics (P = 0.0232) and fewer patients with reoperations (P = 0.0909). The prophylaxis employing decontaminating drugs in the amount of DM 400 lowered post-gastrectomy treatment costs by DM 3800 or 19%. The prophylaxis can be recommended, because it lowers morbidity, mortality and the costs of total gastrectomy.

[General infection prevention in abdominal surgery with special reference to intestinal decontamination]. / Allgemeine Infektionsprophylaxe in der Abdominalchirurgie unter besonderer Berücksichtigung der intestinalen Dekontamination.

In surgery prophylaxis for infection is necessary, because patients are immunocompromised due to the underlying disease and the operation while at the same time being increasingly exposed to potentially pathogenic germs. Prophylaxis is based on the control of endogenous and exogenous microorganisms. For this purpose either systemic or locally active topical agents may be employed. Systemically active substances are applied with the aim to kill and eliminate invasive microorganisms in deep tissue levels, either by their own biological activity or by stimulating specific or unspecific host immune reactions. Local topical measures in contrast are to prevent the primary contact between microorganisms and host. The central pillar of systemic measures is the perioperative systemic antibiotic prophylaxis, immunonutrition is beginning to gain importance, and in the future possibly substances such as G-CSF, which directly stimulate the immune system, may be employed. Standard topical measures are sterilization and desinfection while decontamination of the digestive tract has until now not found a wide spread acceptance. For certain indications especially high risk surgical resections with anastomoses at the level of the oesophagus or the lower rectum it is possible to eliminate endogenous intestinal microorganisms effectively using topical decontamination in combination with systemic antibiotics and improve the surgical results, especially anastomotic healing.

Laparoscopic repair of a Morgagni hernia.

Laparoscopic repair of a diaphragmatic hernia through the right sternocostal foramen of Morgagni in an obese 42-year-old man is described. The indications for surgery were symptoms of strain-induced dyspnea and tightness in the chest. The technique was carried out by incorporating a marlex mesh into the defect and fixing it in place with hernia staples. The patient had an immediate recovery after repair of the hernia and has remained free of recurrence or complaints 9 months after surgery.

Laparoscopic creation of a loop colostomy.

A loop colostomy of the sigmoid colon was constructed in a 48-year-old woman because of stool incontinence owing to a severe sphincter lesion. The operation was performed by laparoscopy. A special 3.5 cm trocar was employed for bringing the sigmoid colon through the abdominal wall. This technique allows the surgeon to avoid a lower median laparotomy in selected cases, and allows discharge of the patient within a few days.

Extracorporeal shock-wave lithotripsy prior to laparoscopic cholecystectomy. Does it make sense?

The extraction of large gallstones in laparoscopic cholecystectomy either requires the enlargement of one of the incisions or intraoperative lithotripsy. Preoperative extracorporeal shock-wave lithotripsy (ESWL) might theoretically solve the problem and facilitate the extraction of the gallbladder. Ten patients with at least one gallstone larger than 20 mm in diameter underwent ESWL treatment within 24 h prior to laparoscopic surgery. Complete pulverization of stones was achieved in one patient. Fragmentation into pieces smaller than 10 mm could be observed in another three cases. Additional mechanical fragmentation employing forceps was necessary in seven and an enlargement of the incision in five of the 10 patients. Compared to a matched group of 10 control patients with gallstones of corresponding size receiving mechanical lithotripsy, the ESWL did not show an advantage, but rather an increase in costs. It therefore cannot be recommended.