A dose-ranging, parallel group, split-face, single-blind phase II study of light emitting diode-red light (LED-RL) for skin scarring prevention: study protocol for a randomized controlled trial.

BACKGROUND: Skin fibrosis is a significant global health problem that affects over 100 million people annually and has a profoundly negative impact on quality of life. Characterized by excessive fibroblast proliferation and collagen deposition, skin fibrosis underlies a wide spectrum of dermatologic conditions ranging from pathologic scars secondary to injury (e.g., burns, surgery, trauma) to immune-mediated diseases. Effective anti-scarring therapeutics remain an unmet need, underscoring the importance of developing novel approaches to treat and prevent skin fibrosis. Our in vitro data show that light emitting diode-red light (LED-RL) can modulate key cellular and molecular processes involved in skin fibrosis. In two phase I clinical trials (STARS 1 and STARS 2), we demonstrated the safety and tolerability of LED-RL at fluences of 160 J/cm2 up to 480 J/cm2 on normal human skin. METHODS/DESIGN: CURES (Cutaneous Understanding of Red-light Efficacy on Scarring) is a dose-ranging, randomized, parallel group, split-face, single-blind, mock-controlled phase II study to evaluate the efficacy of LED-RL to limit post-surgical skin fibrosis in subjects undergoing elective mini-facelift surgery. Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week post-surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks, followed by efficacy assessments at 30 days, 3 months, and 6 months. The primary endpoint is the difference in scar pliability between LED-RL-treated and control sites as determined by skin elasticity and induration measurements. Secondary outcomes include clinical and photographic evaluations of scars, 3D skin imaging analysis, histological and molecular analyses, and adverse events. DISCUSSION: LED-RL is a therapeutic modality of increasing importance in dermatology, and has the potential to limit skin fibrosis clinically by decreasing dermal fibroblast activity and collagen production. The administration of LED-RL phototherapy in the early postoperative period may optimize wound healing and prevent excessive scarring. The results from this study may change the current treatment paradigm for fibrotic skin diseases and help to pioneer LED-RL as a safe, non-invasive, cost-effective, portable, at-home therapy for scars. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03795116 . Registered on 20 December 2018.

Effects of Early Initiation of Solid Versus Liquid Diet after Endoscopic Submucosal Dissection on Quality of Life and Postoperative Outcomes: A Prospective Pilot Randomized Controlled Trial.

BACKGROUND/AIMS: Feeding recommendations after endoscopic submucosal dissection (ESD) for gastric neoplasms are not established and based on clinical experience. METHODS: This was a prospective pilot randomized controlled trial. Patients undergoing ESD for gastric neoplasms were randomly assigned to solid (n = 50) or liquid diet (n = 50) groups. Beginning the day after hemostasis confirmation until discharge, the solid diet group started on a diet of rice porridge, whereas the liquid diet group started on a liquid diet, with gradual transition to solid food. The primary endpoint was delayed bleeding rate. The secondary endpoints were quality of life (QOL), ulcer-stage, hospital fees, and post-ESD symptoms. RESULTS: Delayed bleeding occurred in the solid diet group (2%) but not in the liquid diet group. The QOL evaluation using European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-STO22 showed better score in the solid diet group. The patients who felt dietary restriction at discharge was of a larger number in the liquid diet group (p = 0.019). More patients experienced appetite loss (p = 0.038), constipation (p = 0.022), and dietary restriction (p = 0.037) in the liquid diet group during hospitalization. The other endpoints were equivalent between the groups. CONCLUSION: Early initiation of solid foods after ESD is feasible and associated with higher QOL, potentially rendering conventional liquid diets unnecessary, although additional studies are needed (Trial registration number: UMIN000013297).

Tai Chi Chuan in postsurgical non-small cell lung cancer patients: study protocol for a randomized controlled trial.

BACKGROUND: Impairment of exercise capacity remains a common adverse effect of non-small cell lung cancer (NSCLC) survivors after surgery. Previous research has suggested that Tai Chi Chuan (TCC) offers an exercise capacity benefit in several types of cancers. This is a randomized trial to investigate the efficacy and safety of TCC in postoperative NSCLC patients over an observation period of 3 months and a 9-month follow-up. METHODS/DESIGN: Using a prospective, one center and randomized design, 120 subjects with histologically confirmed stage I-IIIA NSCLC following complete surgical resection will potentially be eligible for this trial. Following baseline assessments, eligible participants will be randomly assigned to one of two conditions: (1) TCC training, or (2) placebo control. The training sessions for both groups will last 60 min and take place three times a week for 3 months. The sessions will be supervised with target intensity of 60-80% of work capacity, dyspnea, and heart rate management. The primary study endpoint is peak oxygen consumption (VO2peak), and the secondary endpoints include: 6-min walk distance (6MWD), health-related quality of life (HRQoL), lung function, immunity function, and the state of depression and anxiety. All endpoints will be assessed at the baseline and postintervention (3 months). A follow-up period of 9 months will be included. The main time points for the evaluation of clinical efficacy and safety will be months 3, 6, 9, and 12 after enrollment. DISCUSSION: This study will assess the effect of group TCC in postsurgery NSCLC survivors on VO2peak, lung function, and other aspects. The results of this study will eventually provide clinical proof of the application of TCC as one kind of exercise training for patients across the entire NSCLC continuum, as well as information on the safety and feasibility of exercise. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR-IOR-15006548 . Registered on 12 June 2015.

The impact of care management information technology model on quality of care after Coronary Artery Bypass Surgery: "Bridging the Divides".

BACKGROUND: Reducing readmissions and improving metrics of care are a national priority. Supplementing traditional care with care management may improve outcomes. The Bridges program was an initial evaluation of a care management platform (CareLinkHub), supported by information technology (IT) developed to improve the quality and transition of care from hospital to home after Coronary Artery Bypass Surgery (CABG) and reduce readmissions. METHODS: CareLink is comprised of care managers, patient navigators, pharmacists and physicians. Information to guide care management is guided by a middleware layer to gather information, PLR (ColdLight Solutions, LLC) and presented to CareLink staff on a care management platform, Aerial™ (Medecision). In addition there is an analytic engine to help evaluate and guide care, Neuron™ (Coldlight Solutions, LLC). RESULTS: The "Bridges" program enrolled a total of 716 CABG patients with 850 admissions from April 2013 through March 2015. The data of the program was compared with those of 1111 CABG patients with 1203 admissions in the 3years prior to the program. No impact was seen with respect to readmissions, Blood Pressure or LDL control. There was no significant improvement in patients' reported outcomes using either the CTM-3 or any of the SAQ-7 scores. Patient follow-up with physicians within 1week of discharge improved during the Bridges years. CONCLUSIONS: The CareLink hub platform was successfully implemented. Little or no impact on outcome metrics was seen in the short follow-up time.

The effect of pre- and post-operative physical activity on recovery after colorectal cancer surgery (PHYSSURG-C): study protocol for a randomised controlled trial.

BACKGROUND: Surgery for colorectal cancer is associated with a high risk of post-operative adverse events, re-operations and a prolonged post-operative recovery. Previously, the effect of prehabilitation (pre-operative physical activity) has been studied for different types of surgery, including colorectal surgery. However, the trials on colorectal surgery have been of limited methodological quality and size. The aim of this trial is to compare the effect of a combined pre- and post-operative intervention of moderate aerobic physical activity and inspiratory muscle training (IMT) with standard care on post-operative recovery after surgery for colorectal cancer. METHODS/DESIGN: We are conducting a randomised, controlled, parallel-group, open-label, multi-centre trial with physical recovery within 4 weeks after cancer surgery as the primary endpoint. Some 640 patients planned for surgery for colorectal cancer will be enrolled. The intervention consists of pre- and post-operative physical activity with increased daily aerobic activity of moderate intensity as well as IMT. In the control group, patients will be advised to continue their normal daily exercise routine. The primary outcome is patient-reported physical recovery 4 weeks post-operatively. Secondary outcomes are length of sick leave, complication rate and severity, length of hospital stay, re-admittances, re-operations, post-operative mental recovery, quality of life and mortality, as well as changes in insulin-like growth factor 1 and insulin-like growth factor-binding protein 3, perception of pain and a health economic analysis. DISCUSSION: An increase in moderate-intensity aerobic physical activity is a safe, cheap and feasible intervention that would be possible to implement in standard care for patients with colorectal cancer. If shown to be effective, this lifestyle intervention could be a clinical parallel to pre-operative smoke cessation that has already been implemented with good clinical results. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02299596 . Registered on 17 November 2014.

Influence of early goal-directed therapy using arterial waveform analysis on major complications after high-risk abdominal surgery: study protocol for a multicenter randomized controlled superiority trial.

BACKGROUND: Early goal-directed therapy refers to the use of predefined hemodynamic goals to optimize tissue oxygen delivery in critically ill patients. Its application in high-risk abdominal surgery is, however, hindered by safety concerns and practical limitations of perioperative hemodynamic monitoring. Arterial waveform analysis provides an easy, minimally invasive alternative to conventional monitoring techniques, and could be valuable in early goal-directed strategies. We therefore investigate the effects of early goal-directed therapy using arterial waveform analysis on complications, quality of life and healthcare costs after high-risk abdominal surgery. METHODS/DESIGN: In this multicenter, randomized, controlled superiority trial, 542 patients scheduled for elective, high-risk abdominal surgery will be included. Patients are allocated to standard care (control group) or early goal-directed therapy (intervention group) using a randomization procedure stratified by center and type of surgery. In the control group, standard perioperative hemodynamic monitoring is applied. In the intervention group, early goal-directed therapy is added to standard care, based on continuous monitoring of cardiac output with arterial waveform analysis. A treatment algorithm is used as guidance for fluid and inotropic therapy to maintain cardiac output above a preset, age-dependent target value. The primary outcome measure is a combined endpoint of major complications in the first 30 days after the operation, including mortality. Secondary endpoints are length of stay in the hospital, length of stay in the intensive care or post-anesthesia care unit, the number of minor complications, quality of life, cost-effectiveness and one-year mortality and morbidity. DISCUSSION: Before the start of the study, hemodynamic optimization by early goal-directed therapy with arterial waveform analysis had only been investigated in small, single-center studies, including minor complications as primary endpoint. Moreover, these studies did not include quality of life, healthcare costs, and long-term outcome in their analysis. As a result, the definitive role of arterial waveform analysis in the perioperative hemodynamic assessment and care for high-risk surgical patients is unknown, which gave rise to the present trial. Patient inclusion started in May 2012 and is expected to end in 2016. TRIAL REGISTRATION: This trial was registered in the Dutch Trial Register (registration number NTR3380) on 3 April 2012.

Effect of decreased parenteral soybean lipid emulsion on hepatic function in infants at risk for parenteral nutrition-associated liver disease: a pilot study.

PURPOSE: We performed a pilot trial to compare reduced dose versus standard soybean lipid emulsion in neonates at risk for parenteral nutrition-associated liver disease. METHODS: A prospective randomized controlled trial was performed (2009-2011) enrolling surgical patients ≥ 26 weeks' gestation anticipated to require >50% of daily caloric intake from parenteral nutrition (PN) for at least 4 weeks. Randomization occurred into either reduced (1.0 g/kg/day) or standard (3g/kg/day) groups. Co-primary outcomes for interpretation of the results were conjugated bilirubin and total bile acids. Additional outcomes included ALT, AST, GGT, alkaline phosphatase, growth, and essential fatty acid levels. Outcomes were compared between treatment groups using Wilcoxon rank sums tests. RESULTS: Twenty-eight patients (47% enrollment rate) were included in the study with an average treatment duration of 5.4 weeks. Groups had similar PN calories and protein intake throughout the study. Total increase from baseline was smaller in the reduced vs. standard group for conjugated bilirubin (p=0.04) and total bile acids (p=0.02). Weight z-score increased more in the standard group, and no patient experienced essential fatty acid deficiency. CONCLUSION: Markers of cholestasis rose at a slower rate using reduced lipid doses. This pilot study demonstrates feasibility and need for a larger study evaluating the effects of reduced lipids in patients at risk for developing parenteral nutrition-associated liver disease.

Haemodynamic performance of neuromuscular electrical stimulation (NMES) during recovery from total hip arthroplasty.

BACKGROUND: Patients post total hip arthroplasty (THA) remain at high risk of developing Deep Vein Thrombosis (DVT) during the recovery period following surgery despite the availability of effective pharmacological and mechanical prophylactic methods. The use of calf muscle neuromuscular electrical stimulation (NMES) during the hospitalised recovery period on this patient group may be effective at preventing DVT. However, the haemodynamic effectiveness and comfort characteristics of NMES in post-THA patients immediately following surgery have yet to be established. METHODS: The popliteal veins of 11 patients, who had undergone unilateral total hip replacement surgery on the day previous to the study, were measured using Doppler ultrasound during a 4 hour neuromuscular electrical stimulation (NMES) session of the calf muscles. The effect of calf muscle NMES on peak venous velocity, mean venous velocity and volume flow were compared to resting values. Comfort was assessed using a 100mm non-hatched visual analogue scale taken before application of NMES, once NMES was initiated and before NMES was withdrawn. RESULTS: In the operated limb NMES produced increases in peak venous velocity of 99% compared to resting. Mean velocity increased by 178% compared to resting and volume flow increased by 159% compared to resting. In the un-operated limb, peak venous velocity increased by 288%, mean velocity increased by 354% and volume flow increased by 614% compared to basal flow (p<0.05 in all cases). There were no significant differences observed between the VAS scores taken before the application of NMES, once NMES was initiated and before NMES was withdrawn (p=.211). CONCLUSIONS: NMES produces a beneficial hemodynamic response in patients in the early post-operative period following orthopaedic surgery. This patient group found extended periods of calf-muscle NMES tolerable. TRIAL REGISTRATION: ClinicalTrials.gov NCT01785251.

Intestinal failure-associated liver disease in surgical infants requiring long-term parenteral nutrition.

PURPOSE: Our aim was to determine incidence, severity, and outcome, as well as predisposing factors and underlying diagnoses, of intestinal failure-associated liver disease (IFALD) in surgical infants requiring long-term parenteral nutrition (PN). METHODS: We retrospectively studied surgical infants receiving PN for at least 28 days for congenital or acquired intestinal anomalies over a 5-year period (January 2006 to December 2010). Intestinal failure-associated liver disease was defined as type 1 (early)--persistent elevation of alkaline phosphatase for 6 weeks or longer; type 2 (established)--additional elevated total bilirubin (≥ 50 µmol/L); and type 3 (late)--additional clinical signs of end-stage liver disease. RESULTS: Eighty-seven infants required PN for at least 28 days. Intestinal failure-associated liver disease occurred in 29 infants (33%). Intestinal failure-associated liver disease was managed medically in all but 2 patients who underwent intestinal elongation. None were referred for intestinal or liver transplant. Intestinal failure-associated liver disease has been reversed in 17 (59%) of cases to date. Sixty-one children receiving long-term PN (70%) have achieved enteral autonomy, whereas 12 (14%) require home PN. Severity of IFALD was significantly associated with duration of PN and female sex. CONCLUSION: Intestinal failure-associated liver disease remains a fairly common but rarely life-threatening complication of intestinal failure in surgical infants. Intestinal failure-associated liver disease can be reversed in more than half of these children, and enteral autonomy was achieved in more than two thirds, even with minimal use of intestinal elongation. This is the first study to demonstrate an association between the severity of IFALD in surgical infants and female sex.

Facial erythema ab igne of rapid onset.

BACKGROUND: Erythema ab igne is a rare condition with a carcinogenic potential produced by chronic exposure to a heat source. CASE DESCRIPTION: We present the first case of rapid-onset erythema ab igne in the setting of a dental practice. CLINICAL IMPLICATION: Physicians and dentists should be aware of this disease following short-term local application of heat.

[Prospective evaluation of the safety and tolerance of colonoscopy in children]. / Evaluación prospectiva de la seguridad y tolerancia de los procedimientos colonoscópicos en pacientes pediátricos.

BACKGROUND: Colonoscopy is a well established diagnostic and therapeutic procedure in pediatrics. AIM: To evaluate colon preparation alternatives for colonoscopy or sigmoidoscopy, type of sedation, clinical indications and findings. PATIENTS AND METHODS: Prospective study of 123 children referred for colonoscopy. Demographic data, type of colon preparation, sedation, type of endoscope and endoscopic results were obtained. The following day, a phone interview was carried out inquiring about duration, quality and adverse effects of the sedation and procedure. RESULTS: Seventy one boys (58%) and 52 girls (42%) with a mean age of 6.7+/-4.4 years, were recruited. The main indication was lower gastrointestinal bleeding (71%). The different colon preparations produced elimination of clear liquid stools in 50%, non transparent liquid in 23%, semi liquid in 22% and solid in 6% of the patients. Most common side effects were abdominal distension (20%) and nausea (16.8%). The most commonly used drugs were midazolam (76%) and demerol (43%). The average duration of the procedure was 18.3 minutes (range: 4-50). The most common findings were rectal polyps (18.7%) and hemorrhagic colitis (14.6%). In 77% of cases, the sedation was considered very good or good. Colon visualization was described as very good (51%) or good (36%). Seventy three percent of children had complete amnesia. The most common adverse effect was vomiting (7.5%). CONCLUSION: Lower endoscopies are feasible procedures to carry out in children, in an ambulatory basis, with intravenous sedation and minimum adverse effects.

Evaluación prospectiva de la seguridad y tolerancia de los procedimientos colonoscópicos en pacientes pediátricos / Prospective evaluation of safety and tolerance of colonoscopy in children

Background: Colonoscopy is a well established diagnostic and therapeutic procedure in pediatrics. Aim: To evaluate colon preparation alternatives for colonoscopy or sigmoidoscopy, type of sedation, clinical indications and findings. Patients and methods: Prospective study of 123 children referred for colonoscopy. Demographic data, type of colon preparation, sedation, type of endoscope and endoscopic results were obtained. The following day, a phone interview was carried out inquiring about duration, quality and adverse effects of the sedation and procedure. Results: Seventy one boys (58%) and 52 girls (42%) with a mean age of 6.7±4.4 years, were recruited. The main indication was lower gastrointestinal bleeding (71%). The different colon preparations produced elimination of clear liquid stools in 50%, non transparent liquid in 23%, semi liquid in 22% and solid in 6% of the patients. Most common side effects were abdominal distension (20%) and nausea (16.8%). The most commonly used drugs were midazolam (76%) and demerol (43%). The average duration of the procedure was 18.3 minutes (range: 4-50). The most common findings were rectal polyps (18.7%) and hemorrhagic colitis (14.6%). In 77% of cases, the sedation was considered very good or good. Colon visualization was described as very good (51%) or good (36%). Seventy three percent of children had complete amnesia. The most common adverse effect was vomiting (7.5%). Conclusion: Lower endoscopies are feasible procedures to carry out in children, in an ambulatory basis, with intravenous sedation and minimum adverse effects.

Diclofenac analgesia following cleft palate surgery.

OBJECTIVE: This prospective study looked at the postoperative hemorrhage risk associated with the use of diclofenac following cleft palate repair. PATIENTS: Twenty consecutive children (6 months to 9 years of age) requiring repair of the hard or soft palate were included. DESIGN AND METHODS: Single per rectum doses of diclofenac were given at 1 mg/kg following cleft palate repair, with additional doses every 12 hours. RESULTS AND CONCLUSIONS: The use of the nonsteroidal anti-inflammatory drug, diclofenac, for postoperative analgesia is well established for many types of surgery. The authors find that twice daily diclofenac rectal suppositories provide very good analgesia postcleft palate repair. This, combined with supplemental oral paracetamol, obviates the need for opiates, resulting in alert infants who feed well and are suitable for early discharge.

[A delayed hemolytic transfusion reaction due to irregular antibodies with an anti-Kidd(a) specificity]. / Verzögerte hämolytische Transfusionsreaktion durch irreguläre Antikörper der Spezifität Anti-Kidd(a).

HISTORY AND CLINICAL FINDINGS: A 56-year-old woman was admitted for replacement of a previously implanted right hip prosthesis which had become loose (no infection). She limped painfully on a shortened leg whose mobility was markedly impaired. At the site of the previous operation the pelvis was lower by about 2 cm; the scar looked well healed. INVESTIGATIONS: Routine laboratory tests were normal except for moderately raised erythrocyte sedimentation rate (18/ 27 mm). There was complete loosening of the prosthesis on X-ray. TREATMENT AND COURSE: Intraoperative bleeding from a branch of the inferior gluteal artery required blood transfusion and further erythrocyte infusions became necessary. Jaundice developed on the 4th postoperative day and 7 days later the direct Coombs test was positive with demonstrable agglutination. Free irregular erythrocytic anti-Kidd(a) (anti-jk[a]) antibodies were found in the serum. To counteract the delayed haemolytic transfusion reaction, exclusively jk(a)-negative erythrocytes were infused. The jaundice gradually disappeared and the bilirubin values became normal. CONCLUSION: Jaundice and signs of haemolysis after erythrocyte transfusion may be due to delayed transfusion reaction and should be investigated with the direct Coombs test.

[The acute toxicity of the simultaneous radiochemotherapy of rectal carcinoma]. / Akuttoxizität der simultanen Radiochemotherapie des Rektumkarzinoms.

AIM: We retrospectively examined the acute toxicity of (neo-)adjuvant combined treatment for rectal cancer in an attempt to evaluate potential factors that influence the severity of toxic side effects. PATIENTS AND METHOD: Between 1987 and 1995, 120 patients with rectal cancer (73 patients with primary tumor, 47 with recurrent disease) received chemoradiation for rectal cancer. Fifty-six patients received preoperative chemoradiation, 64 patients were treated postoperatively. Radiation was given by 4-field box technique with 6 to 10 MV-photons. Daily fraction size was 1.8 Gy, total dose 50.4 Gy (range: 41.4 to 56 Gy) +/- 5.4 Gy (range: 3.6 to 19.8 Gy) local boost in selected cases, specified to the ICRU reference point. During the first and fifth week of radiation 5-FU at a dose of 1000 m2/d for 120 hours was administered by continuous infusion. Toxicity was recorded following (modified) WHO-criteria. RESULTS: Acute grade 3 toxicity occurred mainly as diarrhea (33%), perineal skin reaction (37%), and leukopenia (10%). Extension of the treatment volume including paraaortic lymph nodes (L3) led to a significant increase of grade 3-diarrhea (68% vs. 25%, p = 0.0003) and grade 3-leukopenia (18% vs. 8%, p = 0.03). After abdominoperineal resection less patients suffered from grade 3-diarrhea (8% vs. 47% after sphincter preserving procedures, p = 0.0006), whereas severe perineal erythema occurred more frequently (56% vs. 29%, p = 0.02). Women had significantly more toxic side effects (grade 3-diarrhea: 39% vs. 16% in men, p = 0.04; grade 2 to 3-nausea/emesis: 21% vs. 8% in men, p = 0.018; grade 2 to 3-leukopenia 53% vs. 31% in men, p = 0.02). After preoperative chemoradiation a significant reduction of grade 3-diarrhea (11% vs 29%, p = 0.03) and grade 3-erythema (16% vs. 41%, p = 0.04) was noted. CONCLUSION: Treatment volume, type of surgery, sex and sequence of treatment modalities are the most important factors that influence the severity of toxic side effects. Individual adjustment of 5-FU dosage by monitoring its systemic clearance (which is lower in women) could help to avoid toxic side effects. The reduced acute toxicity of the preoperative approach provides a further argument in favor of the neoadjuvant chemoradiation for rectal cancer.

Post-operative levamisole may compromise early healing of experimental intestinal anastomoses.

There exists growing interest in immediate post-operative local adjuvant therapy after resection of intestinal malignancies. It is therefore necessary to assess it potential effect on the healing of intestinal anastomoses. Five groups (n = 20) of rats underwent resection and anastomosis of both ileum and colon: a control group and four experimental groups receiving intraperitoneal 5-fluorouracil (5-FU), 5-FU plus leucovorin, 5-FU plus levamisole or levamisole alone, on the day of surgery and the next 2 days. Animals were killed 3 or 7 days after operation. Another three groups (n = 6) of animals were used to compare anastomotic collagen synthetic capacity in control rats or rats receiving 5-FU or 5-FU plus levamisole. On the third post-operative day, the average anastomotic bursting pressure in the 5-FU/levamisole group was reduced by 36% as compared with the control group, both in ileum (P = 0.02) and in colon (P = 0.01). Values in the other groups were similar to those in the control group. Anastomotic breaking strength was significantly (P < 0.025) lowered in the ileum from the levamisole group at both days 3 and 7. Anastomotic collagen synthetic capacity was strongly reduced in the 5-FU and 5-FU/levamisole groups. However, there was no significant difference between the control group and the four experimental groups with regard to anastomotic hydroxyproline concentration and content, either 3 or 7 days after operation. Thus, limited use of levamisole, alone or in combination with intraperitoneal 5-FU, may compromise intestinal healing.

GM-CSF in the treatment of a patient with severe methotrexate intoxication.

This case report describes the successful treatment of severe methotrexate intoxication in a 72-year-old female patient. Following two prior uneventful courses of a polychemotherapy regimen including low-dose intravenous (i.v.) methotrexate, the patient presented with fever, polymucositis, incipient pyodermia, acute renal failure and pancytopenia 9 days after the third application. Severe methotrexate overdose was confirmed by serum levels. Using a polypragmatic treatment approach focusing on renal function and including granulocyte-macrophage-colony-stimulating factor (GM-CSF) this life threatening and nearly fatal intoxication was successfully treated. This case report demonstrates that GM-CSF might contribute to rapid reconstitution of leukopoiesis once methotrexate serum levels are in the subtoxic range.

[Solcotrans, a new autotransfusion system]. / Solcotrans, et nyt autotransfusionssystem.

Thirty-one patients scheduled to undergo aortic reconstruction were studied. 16 had aortic aneurysms and 15 required aortobifemoral grafts. The solcotrans unit comprises a rigid plastic container with an inner lining bag, into which blood is aspirated. When the bag is full (500 ml), the unit is inverted and blood is re-infused through a 40 micron filter. Sixty-three percent of the blood transfused per-operatively and 41% peri-operatively was given with the solcotrans unit. Only minor changes in the coagulation parameters were seen. Blood cultures from ten solcotrans units were all negative. Two patients contracted pneumonia, and one cystitis. We conclude that the solcotrans system is safe to use when two-to four units of blood are transfused. Further studies are required to define its role when multitransfusions of blood are needed.