[Feasibility of outpatient laparoscopic sacrocolpopexy surgery: A pilot study]. / Étude pilote de faisabilité de la promontofixation cœlioscopique en ambulatoire.

OBJECTIVE: To evaluate the feasibility of outpatient laparoscopic sacrocolpopexy surgery. METHODS: A prospective analysis was carried out in one center from May 2014 to July 2015. The main outcome was the success of day care, meaning no hospitalization, consultation to a doctor or emergency during the first 48h following the surgery. Patients requiring laparoscopic sacrocolpopexy with eligibility for day care were included. The patients were not included if they didn't match to the administrative or medical criteria of ambulatory, or if they refused ambulatory surgery. The postoperative consultation was 1 month after surgery, the satisfaction was assessed by phone call two months after surgery. RESULTS: We included 14 patients during the study. One patient stayed the night (7.1%). The median operative time of the surgery was 95minutes (70-168minutes), no complication occurred. Ten patients of 13 (76.9%) were very satisfied or satisfied of day care. CONCLUSION: With 71% of satisfaction and only one patient who stayed the night, outpatient laparoscopic sacrocolpopexy surgery seems to be feasible. LEVEL OF EVIDENCE: 4.

[Feasability and morbidity of apical and anterior mesh repair, a multicenter cohort study]. / Suspension utérovaginale prothétique par fixation obturatrice et sacrospinofixation bilatérale, étude multicentrique.

OBJECTIVE: To assess safety anatomic results, satisfaction patient and to report short-term results of a new surgical approach for a combined treatment of pelvic organ prolapse (POP) of anterior and medium compartments. MATERIAL AND METHODS: A longitudinal case series of 83 consecutive patients operated between January 2012 and April 2014 in four tertiary centers by 8 surgeons. Potential complications have been reported. The satisfaction of patients was conducted at 6 weeks post-procedure. The anatomical evaluation was conducted at 6 weeks and 6 months post-procedure. Anatomic success was defined as prolapse stage<1 (POPQ) for both anterior and apical compartment. RESULTS: Mean age was 69.2±8.6 years. There were two intraoperative complications: a bladder injury and an ureteral injury. Postoperative complications were 14/83 (16.8%) transient urinary retentions. Seventy-three patients out of 83 (87.9%) were available for anatomic evaluation at 6 months. Anatomical success at 6 months for both anterior and apical compartments was 68/73 (93.1%). Patient satisfaction rate at 6 months was 79/83 (95.1%). Four subjects/73 (5.5%) experienced mesh exposure treated conservatively. CONCLUSION: In the current series, uterovaginal suspension anterior using a mesh Nuvia® was associated with correct anatomical results and a good satisfaction of patients. This technique seems reproducible and associated with few complications. Prospective, comparative and long-term data are required to confirm these results. LEVEL OF EVIDENCE: 4.

[How to avoid the complications associated with hysterectomy: Place of subtotal hysterectomy, prevention of venous thromboembolism risk and preoperative treatment: Guidelines]. / Complications associées à l'hystérectomie: place de l'hystérectomie subtotale, prévention thromboembolique et traitements préopératoires: recommandations.

OBJECTIVE: The National College of French gynecologists and obstetricians (CNGOF) decided to issue recommendations for clinical practice concerning the prevention of complications due to hysterectomy for benign disease. METHODS: Review of the English and French literature until May 2015 about complications with hysterectomy for benign gynaecological disease, excluding cancer. The following topics are covered in this article: prevention of venous thromboembolism risk, preoperative treatment that reduce the frequency of laparotomic hysterectomy and real interest of subtotal hysterectomy. RESULTS: For the prevention of venous thromboembolism risk we advise to follow the recommendations of the SFAR. In case of hysterectomy for benign indication for which a median laparotomy is envisaged, given the volume of the uterus, it is recommended to prescribe GnRH agonists and then reassess the surgical approach (grade B). We do not observe significative differences regarding the sexual quality of life for laparotomic subtotal hysterectomy versus laparotomic total hysterectomy (EL1). We do not observe significative differences regarding the sexual quality of life for laparoscopic subtotal hysterectomy versus laparoscopic total hysterectomy (EL1). Subtotal hysterectomy is not associated with a significant improvement in the sexual quality of life (EL1). Subtotal hysterectomy is not associated with a decreased prevalence of intraoperative Hemorrhagic or visceral complications (EL3) or to a reduction in transfusions (EL2). It is not recommended to perform subtotal hysterectomy to reduce the risk of complications per or postoperative (grade B).

[Hysterectomy for benign gynaecological disease: Surgical approach, vaginal suture method and morcellation: Guidelines]. / Hystérectomie pour pathologie bénigne: choix de la voie d'abord, technique de suture vaginale et morcellement: recommandations.

OBJECTIVE: To provide clinical practice guidelines from the French college of obstetrics and gynaecology (CNGOF), based on the best evidence available, concerning the surgical approach, the vaginal suture method, the surgeon's experience and morcellation to avoid complications with hysterectomy for benign gynaecological disease. MATERIAL AND METHODS: English and French review of literature about complications with hysterectomy for benign gynaecological disease, excluding cancer. RESULTS AND CONCLUSION: For benign gynaecological disease, vaginal (VH) or laparoscopic (LH) hysterectomy are recommended (grade B). In case of big uterus, VH or LH are recommended (grade C). VH is not contraindicated in nulliparous (Grade C). VH is not contraindicated in case of previous caesarean (grade C). In obese women, VH and LH are recommended (grade C). It should be recommended to perform at least 30 hysterectomies during learning curve (grade C). Hysterectomy should be performed by surgeon doing at least 10 hysterectomies each year (grade C). No vaginal suture method is recommended (grade C). It is recommended to assess cancer risk before (histological sample and/or imagery) when morcellation is planned (expert opinion).

[Urinary, infectious and digestive adverse events related to benign hysterectomy and the associated surgery on the Fallopian tube: Guidelines]. / Hystérectomies d'indication bénigne: complications viscérales et gestes associés sur les annexes: recommandations.

OBJECTIVES: To provide clinical practice guidelines from the French College of Obstetrics and Gynecology (CNGOF) based on the best evidence available, concerning the urinary, infectious and digestive adverse events related to benign hysterectomy and the associated surgery including opportunistic salpingectomy and adnexectomy. MATERIAL AND METHOD: Review of literature using following keywords: benign hysterectomy; urinary injury; bladder injury; ureteral injury; vesicovaginal fistula; infection; bowel injury; salpingectomy. RESULTS: Urinary catheter should be removed before 24h following uncomplicated hysterectomy (grade B). In case of urinary catheter during hysterectomy, immediate postoperative removal is possible (grade C). No hemostasis technics can be recommended to avoid urinary injury (grade C). There is not any evidence to recommend to perform a window in the broad ligament or an ureterolysis, to put ureteral stent or a uterine manipulator in order to avoid ureteral injury. An antibiotic prophylaxis by a cephalosporin is always recommended (grade B). Mechanical bowel preparation before hysterectomy is not recommended (grade B). If there is no ovarian cyst/disease and no familial or personal history of ovarian/breast cancer, ovarian conservation is recommended in premenopausal women (grade B). In postmenopausal women, informed consent and surgical approach should be taken in account to perform a salpingo-oophorectomy. Since the association salpingectomy and hysterectomy is not assessed in the prevention of ovarian cancer, systematic bilateral salpingectomy is not recommended (expert consensus). CONCLUSIONS: Practical application of these guidelines should decrease the prevalence of visceral complications associated with benign hysterectomy.

[Hysterectomy for benign pathology: Guidelines for clinical practice]. / Hystérectomie pour pathologie bénigne: recommandations pour la pratique clinique.

OBJECTIVE: The objective of the study was to provide guidelines for clinical practice from the French college of obstetrics and gynecology (CNGOF), based on the best evidence available, concerning hysterectomy for benign pathology. METHODS: Each recommendation for practice was allocated a grade which depends on the level of evidence (guidelines for clinical practice method). RESULTS: Hysterectomy should be performed by a high volume surgeon (>10 procedures of hysterectomy per year) (grade C). Rectal enema stimulant laxatives are not recommended prior to hysterectomy (grade C). It is recommended to carry out vaginal disinfection using povidone iodine solution prior to an hysterectomy (grade B). Antibioprophylaxis is recommended during a hysterectomy, regardless of the surgical route (grade B). The vaginal or the laparoscopic routes are recommended for hysterectomy for benign pathology (grade B), even if the uterus is large and/or the patient is obese (grade C). The choice between these two surgical approaches depends on others parameters, such as the surgeon's experience, the mode of anesthesia and organizational constraints (operative duration and medico economic factors). Hysterectomy by vaginal route is not contraindicated in nulliparous women (grade C) or in women with previous c-section (grade C). No specific technique to achieve hemostasis is recommended with a view to avoid urinary tract injuries (grade C). In the absence of ovarian pathology and personal or family history of breast/ovarian carcinoma, it is recommended to conserve ovaries in pre-menopausal women (grade B). Subtotal hysterectomy is not recommended in order to diminish the risk of per- or postoperative complications (grade B). CONCLUSION: The application of these recommendations should minimize risks associated with hysterectomy.

Modeling the dispersion of viable and total Escherichia coli cells in the artificial semi-enclosed bathing area of Santa Marinella (Latium, Italy).

Coastal areas are strongly affected by episodes of fecal contamination due to polluted water inflows from inadequately treated sewages. The present study aims to investigate the dispersion of Escherichia coli in the artificial semi-enclosed bathing area of Santa Marinella (Latium, Italy) through in situ samplings carried out in summer 2012 and the application of a dynamic model. Collected samples were analyzed by the Culture-Based technique and the Fluorescent Antibody method in order to estimate both the viable culturable cells and the total E. coli population, respectively. The in situ datasets were used to test the proposed modeling approach and simulate the behavior of bacteria as particles subjected, or not, to decay. Next, the flushing time and the computation of the Microbiological Potential Risk Area allowed the evaluation of the contribution of physical and biological processes to coliform dispersion and the related potential risk for bathers.

[Cervical ripening after previous cesarean section with Foley catheter: A prospective study of 41 patients]. / Maturation cervicale des utérus unicicatriciels par sonde de Foley : étude prospective de 41 patientes.

OBJECTIVES: Effectiveness of cervical ripening with Foley catheter for patients requiring labor induction with a previous cesarean section and unfavorable cervical conditions. PATIENTS AND METHODS: Prospective unicentric study conducted between 1 April 2011 and 31 October 2013 on 41 patients with medical indication for labor induction with a Bishop's score<7 and one previous cesarean section. Outcomes evaluated were mode of delivery, Bishop's score variations and maternal or neonatal complications. RESULTS: Cervical ripening was performed in 39 patients and 17 (43.5%) were delivered vaginally. A total of 24/39 (61.5%) patients were put into work and 10/39 (25.6%) came into work immediately after removal of the Foley catheter. The average score improvement Bishop was 2.7±0.6 points. No maternal or fetal complication was reported. CONCLUSION: Foley catheter is an interesting procedure in patients with previous cesarean section and unfavorable cervical conditions requiring labor induction.

[Port-site metastasis after retroperitoneal lymphadenectomy for endometrial adenocarcinoma]. / Métastase orificielle sur site de trocart après lymphadénectomie rétropéritonéale pour un adénocarcinome endométrial.

Port-site metastasis is a rare but serious complication of laparoscopic surgery. The etiologies are poorly identified and multiple. We report the case of port-site metastasis after laparoscopic retroperitoneal lymphadenectomy for endometrial adenocarcinoma. In the literature, three cases of port-site metastasis after laparoscopic retroperitoneal lymphadenectomy are reported: two cases concerning cervical cancer and one case concerning a kidney cancer. To our knowledge, this is the only case about port site metastasis after laparoscopic retroperitoneal lymphadenectomy for endometrial adenocarcinoma.

[Indications of mesh in surgical treatment of pelvic organ prolapse by vaginal route: expert consensus from the French College of Gynecologists and Obstetricians (CNGOF)]. / Indications de la cure du prolapsus génital par voie vaginale avec prothèse : consensus d'experts du Collège national des gynécologues et obstétriciens français (CNGOF).

OBJECTIVE: To determine the indications and contraindications concerning prosthetic surgery by vaginal route for pelvic organ prolapse. METHODS: Literature review and rating of proposals using a formal consensus method. RESULTS: Before surgery for genital prolapse, the patient should be counselled about the different existing techniques (abdominal and vaginal surgery with and without mesh), the reasons why the surgeon offered her the placement of a synthetic mesh and also other nonsurgical treatments (pelvic floor rehabilitation and pessary). The intervention must be preceded by an assessment of bothersome pelvic, urinary, digestive and sexual symptoms. For the surgical treatment of cystocele, the use of a synthetic mesh placed by vaginal route is not recommended routinely. It should be discussed on a case by case considering the risk/benefit ratio. In patients presenting with cystocele recurrence, the placement of a synthetic mesh is a reasonable option, in order to reduce the risk of cystocele recurrence. With the exception of a few situations (rectocele recurrence), the placement of a synthetic mesh is not recommended as first-line therapy for the surgical treatment of rectocele by vaginal route. In case of uterine or vaginal vault prolapse, repositioning the vaginal vault or uterus using synthetic mesh arms is not recommended as first-line surgical therapy. CONCLUSION: Surgeons should implement established preventive recommendations that may reduce the risk of complications.

[Cervical ripening at term with repeated administration of dinoprostone vaginal pessary]. / Maturation cervicale à terme par utilisation répétée du dispositif intravaginal de dinoprostone.

OBJECTIVES: To evaluate efficacy and safety of cervical ripening with repeated administration of dinoprostone slow release vaginal pessary (Propess®) in current practice. PATIENTS AND METHODS: An observational study of 111 women who underwent cervical ripening with two Propess® during the study period from 1st July 2007 to 31st October 2011. Modes of delivery, success of cervical ripening, failure of labor induction, maternal and neonatal morbidity were reported. RESULTS: The nulliparous rate was 75,7%. The main indications for induction of labor were post-term pregnancy in 34,3% (38/111) and premature rupture of membranes in 25,2% (28/111). The rate of vaginal delivery was 53,1% (59/111). Cesarean sections were performed for failure of labor induction in 27/52 (51,9%) and an abnormal fetal heart rate in 17/52 (32.7%). Indication for induction of labor, nulliparous patients (44 [84.6%] versus 40 [67.8%]; P=0.04), initial Bishop score (2.2±1.2 versus 2.9±1.2; P=0.04) before the cervical ripening and Bishop score before administration of second Propess® (3.3±1.4 versus 4.0±1.2; P=0.05) were significant risk factors of cesarean delivery. DISCUSSION AND CONCLUSION: In more than half of the cases, the cervical ripening by two Propess® is efficient and allows a vaginal delivery. This practice does not appear to increase the maternal or neonatal morbidity.

[Surgical treatment of ectopic pregnancy by single port access with SILS® system: preliminary study]. / Traitement de la grossesse extra-utérine par accès endoscopique unique avec le système SILS® : expérience initiale.

AIM: To evaluate feasibility of surgical treatment for ectopic pregnancy with single laparoscopic access with SILS(®) system. PATIENTS AND METHODS: We conducted an open study from 1/7/2009 to 1/12/2010 in a single gynaecologic department. All procedures were performed by three operators. Procedures evaluated were corneal resection, salpingotomy, salpingectomy. Feasibility, per- and postoperative data were reported. RESULTS: We performed completely 31 over 32 (97%) surgical procedures with SILS(®) system (27 salpingectomies and five salpingotomies). In one case, conversion to conventional laparoscopy was required. No intra- or postoperative complications were reported. CONCLUSION: Laparoscopic surgery for ectopic pregnancy by single access seems feasible with SILS(®) system. Further study including larger number of patients and operators were necessary to confirm risks and advantages of this technique.

[Single laparoscopic access: initial experience]. / Chirurgie laparoscopique par accès unique : expérience initiale.

OBJECTIVE: To evaluate feasibility of single laparoscopic access with LESS(®) system. PATIENTS AND METHODS: We conducted an open study from 1/7/2009 to 1/10/2010 in a single gynaecologic department. All procedures were performed by four operators. Procedures evaluated were total hysterectomy, adnexectomy and ovarian cystectomy. Feasibility, per- and postoperative data were reported. RESULTS: We performed completely 24/25 (96 %) total hysterectomies by single laparoscopic access. Traditional laparoscopy and finally laparotomy was necessary for one patient. Bladder injury repaired by vaginal approach was reported in one patient. We performed 29 adnexectomies in 19 patients (nine unilaterals et 10 bilaterals) and six ovarian cystectomies in four patients (four unilaterals et two bilaterals). All procedures were performed successfully by single laparoscopic access. Parietal haematoma were reported in two patients. DISCUSSION AND CONCLUSION: Laparoscopic gynaecologic surgery by single access seems feasible with LESS(®) system for these procedures. Further study including larger number of patients and operators were necessary to confirm risks and advantages of this technique.

[Obesity and Eating Disorders. Indications for the different levels of care. An Italian Expert Consensus Document]. / Documento di Consensus. Obesità e Disturbi dell'Alimentazione Indicazioni per i diversi livelli di trattamento.

This paper is an Italian Expert Consensus Document on multidimensional treatment of obesity and eating disorders. The Document is based on a wide survey of expert opinion. It presents, in particular, considerations regarding how clinicians go about choosing the most appropriate site of treatment for a given patient suffering from obesity and/or eating disorders: outpatient, partial hospitalization, residential rehabilitation centre, inpatient hospitalization. In a majority of instances obesity and eating disorders are long-term diseases and require a multiprofessional team-approach. In determining an initial level of care or a change to a different level of care, it is essential to consider together the overall physical condition, medical complications, disabilities, psychiatric comorbidity, psychology, behaviour, family, social resources, environment, and available services. We first created a review manuscript, a skeleton algorithm and two rating scales, based on the published guidelines and the existing research literature. As the second point we highlighted a number of clinical questions that had to be addressed in the specific context of our National Health Service and available specialized care units. Then we submitted eleven progressive revisions of the Document to the experts up to the final synthesis that was approved by the group. Of course, from point to point, some of the individual experts would differ with the consensus view. The document can be viewed as an expert consultation and the clinical judgement must always be tailored to the particular needs of each clinical situation. We will continue to revise the Document periodically based on new research information and on reassessment of expert opinion to keep it up-to-date. The Document was not financially sponsored.

Health status of children with cerebral palsy living in Europe: a multi-centre study.

AIM: The aim of this report is to describe the health status of 8-12-year-old children with cerebral palsy (CP) of all severities in Europe using the Child Health Questionnaire (CHQ). METHOD: A total of 818 children with CP from nine centres in defined geographical areas participated. CP type, gross and fine motor function, additional impairments were classified and family data were obtained. The CHQ was used to measure the parent's perception of their child's physical (PHY) and psychosocial (PSY) health. RESULTS: PHY scores were lower than the reference samples with a median of 46. The severity of gross motor function influenced the CHQ scores significantly in the PHY scale with the lowest scores for children with least gross motor function. There were significant differences between the CP types in PHY with the higher scores for children with unilateral spastic and the lowest scores for children with bilateral spastic and dyskinetic CP type. Fine motor function severity significantly affected both the PHY and PSY scales. The severity of intellectual impairment was significantly associated with CHQ scores in most dimensions with higher scores for higher IQ level in PHY and PSY. Children with seizures during the last year had a significantly lower health compared with children without seizures. The results of the multivariate regression analyses (forward stepwise regression) of CHQ scores on CP subtype, gross and fine motor function, cognitive function, additional impairments, seizures, parental education and employment revealed gross motor function, cognitive level and type of school attended were significant prognostic factors. CONCLUSION: This report is based on the largest sample to date of children with CP. Health status as measured using the CHQ was affected in all children and was highly variable. Gross motor function level correlates with health from the PHY well-being perspective but the PSY and emotional aspects do not appear to follow the same pattern.

[Nutrition in diabetic nephropathy]. / Problematiche nutrizionali nella nefropatia diabetica.

The incidence of end-stage renal failure has increased in Italy from 70-80 to 120 per 1x10(6). About 20-30% of patients with diabetes develop nephropathy, usually within 20-25 yrs after disease onset. Diet plays an essential role in the therapy of diabetic nephropathy. A well planned diabetic diet with intensive glycemic control can significantly reduce the risk of microalbuminuria development, and moderate protein restriction reduces hyperfiltration and intraglomerular pressure, and retards the progression of diabetic glomerulopathy. Various studies have shown a positive effect of diet with a protein intake of approximately 0.8 g/kg(-1)/day(-1) in patients with overt nephropathy, with a further restriction to 0.6 g/kg(-1)/day(-1) when the glomerular filtration rate begins to fall. Extra protein intake should counterbalance massive proteinuric losses.

Cutaneous bacterial colonization, modalities of chemotherapeutic infusion, and catheter-related bloodstream infection in totally implanted venous access devices.

GOALS OF WORK: Prospective clinical study to evaluate patients suffering from solid tumor using a totally implanted venous access device (TIVAD) to determine: (1) if there is a relationship between cutaneous contamination at port insertion site and catheter-related bloodstream infection (CRBI); (2) development modalities of CRBI; (3) if there is a relationship between chemotherapy administration modalities by push/ bolus versus continuous infusion and CRBI. PATIENTS AND METHODS: We studied 41 consecutive patients who needed a TIVAD positioned for chemotherapy administration by bolus/ push or continuous infusion. In every patient, we performed blood cultures from blood samples from port catheters and cutaneous cultures from cutaneous tampons of the skin surrounding the implant area on the first (T0) and eight day (T1) postoperatively, after 1 month (T2), and after 3 months (T3) from insertion. MAIN RESULTS: The study was completed on 40 patients; in one case, the port was removed at T2 for septic complications. We obtained four positive blood cultures (two, 5%), two in the same patient, all caused by staphylococcus. Positive cutaneous tampons were 21 (13%) in 11 patients (27%); the four CRBI occurred in this group of patients with none in the remaining 30 patients (73%) for a total number of 120 tampons (p<0.01). In two cases, the same germ was isolated from both the skin and blood. None of the patients presented a local infection of the subcutaneous pocket. Positive cutaneous cultures decrease over time: T0-T2; 24-5%; T1-T3, 20-5% (p<0.04). There were no differences in CRBI incidence and positive cutaneous tampons between the two chemotherapy administration modalities. CONCLUSIONS: Cutaneous microbial flora has a primary role in CRBI development within TIVADs; there is a relationship between cutaneous colonization and CRBI; colonization reaches its maximum during the first days after catheterization in which the use of the system is at high risk; colonization occurs both via extraluminal and endoluminal routes; there is no difference in CRBI incidence between bolus and continuous infusion administration.

Systemic and haemodynamic toxicity after isolated limb perfusion (ILP) with TNF-alpha.

The aim of this study was to evaluate the systemic and haemodynamic postoperative effects of ILP with medium-low dose of TNF alpha in patients diagnosed with primary or recurrent limb melanoma or sarcoma, and to compare the resulting toxicity with Systemic Inflammatory Response Syndrome (SIRS). A prospective study on 17 consecutive patients with primary or recurrent limb tumor (melanoma or sarcoma) subjected to ILP with escalating doses of TNF alpha (0.5-2.0mg) was carried out. Seventeen patients with primary or recurrent limb melanoma or sarcoma were subjected to ILP with escalating doses of TNF alpha. ILP was carried out with the standard techniques, blood being warmed at 42 degrees C for an hour. Serial serum TNF alpha determinations were performed before, during and after limb perfusion in nine patients. Systemic and pulmonary haemodynamics, by a radial and pulmonary artery catheter inserted before the induction of anesthesia, were monitored at 5 different times: before the induction of anesthesia (T0), and 6, 12, 24 and 48 hours after treatment (T1-4). Complete isolation of the limb was not always achieved, therefore leakage of TNF alpha occurred frequently during the perfusion in all patients with maximum systemic TNF alpha concentrations ranging from 431 to 111000 pg/ml. After perfusion only two patients showed detectable TNF alpha levels in peripheral blood which returned to baseline values within nine hours. These two patients had serious systemic toxicity: shock and respiratory failure secondary to pulmonary edema. Acute pulmonary edema was also observed in another patient. All three cases required supportive therapy provided by means of mechanical ventilation. In the remaining 14 patients a sepsis-like syndrome was observed. The most significant haemodynamic changes were due to the CO, which rose by 35%, and the SVR, which remained consistently low throughout. A reduction in Hb was observed in all patients (with an average decrease of 4 g/dl), while DO2 and VO2 levels rose, though not to statistically significant levels. Hypoxia occurred in all 14 patients. In three of the remaining 14 cases bilateral pulmonary leaks were noted, however the use of mechanical ventilation was not required. No perioperative death occurred and the aforementioned side effects were all reversible resulting in a patient's mean postoperative ICU permanence of 4 days (range 3 to 7 days). In conclusion, ILP with TNF alpha induces cardiovascular, respiratory and hematological toxicity with haemodynamic parameters being similar to those noted in SIRS probably due to leakage of TNF alpha in the systemic circulation during the perfusion. Nevertheless, this systemic toxicity was short-lived resulting in an acute reaction following a single application.