Postoperative adhesion formation and reproductive outcome using Interceed after ovarian surgery: a randomized trial in the rabbit model

The efficacy of an oxidized regenerated cellulose barrier (Interceed) in reducing postoperative adhesion formation and improving reproductive outcome after ovarian surgery was evaluated in a prospective randomized trial. Twenty-nine New Zealand White female rabbits were submitted to a mid-line laparotomy and a standardized surgical incision was made on both ovaries. At random, one ovary was entirely wrapped in a sheet of Interceed, whereas the contralateral ovary was left uncovered. Four weeks following surgery, the rabbits were mated with a male of proven fertility. Two weeks later, a second-look laparotomy was performed by a blinded observer who evaluated the incidence and score of adhesions, the number of corpora lutea in each ovary, the number of embryos in the ipsilateral uterine horn and also calculated the nidation index for each side. Adhesions were observed in 66% of Interceed-covered and in 97% of control ovaries (P < 0.0001). The adhesion score on the Interceed side was significantly lower than on the control side. The nidation index for the Interceed side was significantly higher than for the control side. The authors conclude that, in the rabbit model, Interceed significantly reduces the incidence and score of postoperative ovarian adhesions and significantly improves reproductive outcome.     

Interaction of Interceed oxidized regenerated cellulose with macrophages: a potential mechanism by which Interceed may prevent adhesions

OBJECTIVE: The objective of the study was to determine whether Interceed oxidized regenerated cellulose (Johnson & Johnson Medical, Arlington, Tex.), because of its polyanionic nature, may compete for the macrophage scavenger receptor. STUDY DESIGN: RAW macrophages were incubated with Interceed oxidized regenerated cellulose and known scavenger receptor ligands. The production of interleukin-1beta by mouse peritoneal macrophages was measured in the presence of Interceed cellulose. RESULTS: When macrophages were incubated with Interceed cellulose, increasing concentrations inhibited the uptake of fluorescent acetyl low-density lipoprotein. In the presence of Interceed cellulose there was a decrease in the production of interleukin-1beta by mouse macrophages. CONCLUSION: These results suggest that the interaction of Interceed oxidized regenerated cellulose with macrophages with scavenger receptors may result in a decreased secretion of matrix components, inflammatory mediators, and cellular growth factors. Thus Interceed cellulose may function as a biologic barrier in preventing adhesions.     

A randomized trial to evaluate the effectiveness of dietary advice by practice nurses in lowering diet-related coronary heart disease risk

BACKGROUND: Dietary factors are an important contribution to the high rates of coronary heart disease in the UK. One approach to achieving change is health-promoting advice in primary care. AIM: To compare the effectiveness of structured dietary advice by practice nurses with standard health education in changing serum cholesterol, weight and diet. METHOD: Randomized, controlled trial within eight general practices in England and Wales allocated within matched geographical pairs to 'dietary advice' or 'usual care'. Men and women aged 35-59 years, recruited opportunistically by their GPs, underwent health checks. In 'dietary advice' practices, subjects received dietary advice from specially trained nurses based on negotiated change principles, reinforced at follow up. In 'usual care' practices, subjects were only given standard health education materials. RESULTS: A total of 956 patients were recruited: 473 in 'dietary advice' practices and 483 in 'usual care' practices. Compliance with annual follow up was 80%. Compared with 'usual care' practices, there was a mean 0.20 mmol/l lower serum cholesterol (95% CI -0.38 to -0.03 at 1 year) in 'dietary advice' practices. There was a small fall in weight of 0.56 kg (95% CI -1.04 to -0.07) and reductions in total and saturated fat. Factor VII coagulant activity fell by a mean of 6.7% of the standard (95% CI -15.4 to +2.0). CONCLUSION: Provision of standard health education material alone as part of a health check had no effect on coronary heart disease risk factors. There were modest changes in diet and associated risk factors when a more intensive and individual approach to dietary advice was given by practice nurses. This is, however, probably an ineffective use of resources, except in those at high risk of coronary heart disease. Whole-population strategies to achieve dietary change are required.     

Prevention of post-surgical adhesion formation using aspirin in a rodent model: a preliminary report

Pelvic adhesions are one of the major factors which significantly and adversely affect surgery outcome due to intra- and postoperative morbidity and reduce future female fertility. Using a rodent model, we evaluated the efficacy of aspirin, a non-steroidal anti-inflammatory drug, in the prevention of adhesion formation. A total of 72 female Wistar rats received a standardized primary traumatic lesion to the right uterine horn. They were randomly divided into eight groups: group I (control) had no treatment and group II received a single pre-operative 0.70 mg aspirin. All the succeeding groups (III-VIII) received aspirin in doses of 0.35, 0.70, or 1.40 mg every 6 h for either 48 or 96 h in addition to the pre-operative aspirin (0.70 mg). All animals were killed 4 weeks later and adhesions were assessed using a modified adhesion scoring scale. The lowest adhesion score was found in the group treated with 0.35 mg of aspirin for 96 h, and the highest was found among the groups treated with either 0.70 or 1.40 mg for 48-96 h respectively (P < 0.05). These results are in line with the hypothesis that administration of a low dose of aspirin selectively inhibits the production of thromboxane A2, whereas basal prostacyclin biosynthesis is preserved. This phenomenon might contribute to reducing postoperative adhesion formation in a rat model. Thus, future studies into the prevention of adhesion formation may require the additional use of a non-steroidal anti-inflammatory drug, for which aspirin deserves further attention, before extrapolation into human therapy.     

Instruments to evaluate fitness to stand trial:a review of recent literature

DNA index (DI) values seen in 86 sporadic colorectal adenocarcinomas were related to clinical, morphological, and disease progression features. DI, whose overall distribution was bimodal with peaks in the diploid and from hypotriploid to tetraploid ranges, was related to pathological lymph node staging (pN), staging, lymphoid reaction, and tubular configuration. With increasing severity in pathological features, an irregular shift in DI class prevalence was seen, with no steady increase from diploidy to higher degrees of aneuploidy. All UICC stage I tumors (13% of total) were aneuploid, 50% being hypertriploid; diploidy (35%) and hypertriploidy (22%) prevailed in stage II carcinomas (41% of total), diploidy (35%) and hypotriploidy (30%) in stage III (30% of total), and triploidy (33%) in stage IV (15% of total). Amongst features related to stage (lymphoid reaction, depth of neoplastic embolization, grading, tubular configuration, and polymorphism), few were associated with DI, and none influenced DI shift and class prevalence through the stages. The biological capabilities of colorectal adenocarcinoma in relation to stage are expressed by certain aneuploid DI classes (hypertriploidy: absence of extracolonic spread; hypotriploidy: lymph node metastases; triploidy: distant metastases). Diploidy is unrelated to criteria defining stage above I and predicts 50% of cases with development of metachronous metastases. Irregular DI class shift through the stages may be attributable to different pathways of cancerogenesis and disease progression in diploid versus aneuploid carcinomas. Alternatively, assuming that the diploid fraction in aneuploid tumors contains neoplastic cells, pure diploid carcinomas represent the selection of a vital clone that may give rise to a further mixed population whose aneuploid DI is different and best fitted to express the biological capabilities of that given stage.     

Prevention of respiratory complications after abdominal surgery: a randomised clinical trial

OBJECTIVE: To evaluate the prevention of respiratory complications after abdominal surgery by a comparison of a global policy of incentive spirometry with a regimen consisting of deep breathing exercises for low risk patients and incentive spirometry plus physiotherapy for high risk patients. DESIGN: Stratified randomised trial. SETTING: General surgical service of an urban teaching hospital. PATIENTS: 456 patients undergoing abdominal surgery. Patients less than 60 years of age with an American Society of Anesthesia classification of 1 were considered to be at low risk. OUTCOME MEASURES: Respiratory complications were defined as clinical features consistent with collapse or consolidation, a temperature above 38 degrees C, plus either confirmatory chest radiology or positive results on sputum microbiology. We also recorded the time that staff devoted to prophylactic respiratory therapy. RESULTS: There was good baseline equivalence between the groups. The incidence of respiratory complications was 15% (35/231) for patients in the incentive spirometry group and 12% (28/225) for patients in the mixed therapy group (P = 0.40; 95% confidence interval -3.6% to 9.0%). It required similar amounts of staff time to provide incentive spirometry and deep breathing exercises for low risk patients. The inclusion of physiotherapy for high risk patients, however, resulted in the utilisation of an extra 30 minutes of staff time per patient. CONCLUSIONS: When the use of resources is taken into account, the most efficient regimen of prophylaxis against respiratory complications after abdominal surgery is deep breathing exercises for low risk patients and incentive spirometry for high risk patients.     

The benefits of active rewarming after cardiac operations: a randomized prospective trial

Studies were carried out to observe the species composition of mosquitos and to determine the vectors responsible for the transmission of filariasis in Grik, Perak, Malaysia. A total of 2,155 mosquitos belonging to 7 genera and 30 species were collected. Anopheles donaldi comprised 24.1% of the collection. Twelve out of 519 An. donaldi were infected with L3 larvae of Brugia malayi. The peak biting time was around 23.00-24.00 hours. The infective bites per month ranged from 0 to 6.3.     

Continuous postoperative infusion of a regional anesthetic after an amputation of the lower extremity. A randomized clinical trial

We performed a prospective, randomized clinical trial to determine whether continuous infusion of bupivacaine hydrochloride decreased the use of narcotics for the relief of pain after an amputation. Twenty-one patients who were to have an amputation of the lower extremity because of ischemic necrosis secondary to peripheral vascular disease were divided into two groups with use of a table of random numbers. Group A (the treatment group) included nine patients who were to have a transtibial amputation, one patient who was to have a disarticulation at the knee, and one patient who was to have a transfemoral amputation. Group B (the control group) included seven patients, two patients, and one patient, respectively. After the amputation had been performed, a Teflon catheter was placed adjacent to the transected end of the sciatic or posterior tibial nerve. Postoperatively, the patients received continuous infusion of either bupivacaine (Group A) or normal saline solution (Group B) for seventy-two hours. Intravenous administration of morphine with use of a patient-controlled pump also was permitted during this period. The amount of morphine that was used was recorded meticulously. The patients in Group A used less morphine during the first and second days after the operation than did those in Group B. There was no difference between the groups with regard to the amount of morphine used on the third postoperative day. Over-all, eleven of fourteen patients who completed questionnaires reported a decrease in pain between the three and six-month evaluations. We concluded that continuous perineural infusion of an anesthetic appears to be a safe, effective method for the relief of postoperative pain but that it does not prevent residual or phantom-limb pain in patients who have had an amputation of the lower extremity because of ischemic changes secondary to peripheral vascular disease.     

Postoperative radiotherapy in the treatment of single metastases to the brain: a randomized trial

CONTEXT: For the treatment of a single metastasis to the brain, surgical resection combined with postoperative radiotherapy is more effective than treatment with radiotherapy alone. However, the efficacy of postoperative radiotherapy after complete surgical resection has not been established. OBJECTIVE: To determine if postoperative radiotherapy resulted in improved neurologic control of disease and increased survival. DESIGN: Multicenter, randomized, parallel group trial. SETTING: University-affiliated cancer treatment facilities. PATIENTS: Ninety-five patients who had single metastases to the brain that were treated with complete surgical resections (as verified by postoperative magnetic resonance imaging) between September 1989 and November 1997 were entered into the study. INTERVENTIONS: Patients were randomly assigned to treatment with postoperative whole-brain radiotherapy (radiotherapy group, 49 patients) or no further treatment (observation group, 46 patients) for the brain metastasis, with median follow-up of 48 weeks and 43 weeks, respectively. MAIN OUTCOME MEASURES: The primary end point was recurrence of tumor in the brain; secondary end points were length of survival, cause of death, and preservation of ability to function independently. RESULTS: Recurrence of tumor anywhere in the brain was less frequent in the radiotherapy group than in the observation group (9 [18%] of 49 vs 32 [70%] of 46; P<.001). Postoperative radiotherapy prevented brain recurrence at the site of the original metastasis (5 [10%] of 49 vs 21 [46%] of 46; P<.001) and at other sites in the brain (7 [14%] of 49 vs 17 [37%] of 46; P<.01). Patients in the radiotherapy group were less likely to die of neurologic causes than patients in the observation group (6 [14%] of 43 who died vs 17 [44%] of 39; P=.003). There was no significant difference between the 2 groups in overall length of survival or the length of time that patients remained functionally independent. CONCLUSIONS: Patients with cancer and single metastases to the brain who receive treatment with surgical resection and postoperative radiotherapy have fewer recurrences of cancer in the brain and are less likely to die of neurologic causes than similar patients treated with surgical resection alone.     

The effectiveness of pre-operative advice to stop smoking: a prospective controlled trial

Patients who smoke cigarettes suffer increased postoperative morbidity. A prospective, controlled trial was designed to evaluate the effectiveness of written pre-operative advice to stop smoking before admission for elective surgery and to record the duration of abstinence immediately before the operation. Although the advice was ineffective in persuading patients to stop smoking, it was associated with a reduction in the amount of tobacco consumed. Nicotine and carbon monoxide have important short-term adverse effects but 15% of all patients continued to smoke within an hour of surgery. If patients are unable to give up cigarette smoking completely, it is still worthwhile stopping on admission to hospital.     

Use of chemiluminescent method for evaluation of postoperative adhesion formation after reproductive pelvic surgery: an experimental study

Surgery on the uterine horns was performed on 160 animals with application of catgut (CG) and prolene (PN), as well as the assisting application of interceed (TC 7) and fibrin glue (FG). The data of chemiluminescence (CL) of peritoneal phagocytes (PP) were compared with the results of evaluation of reparative wound regeneration. It was determined that the initial level and spontaneous CL activity of phagocytes in healthy animals was low or there were none of them that testified to a quiet cellular state. The maximal activating effect on PP was produced by CG, less so by FG, even less by TC 7, and the least by PN.     

Using a model of transactional developmental regulation to evaluate the effectiveness of an early intervention programme for pre-school children with motor impairments

This study investigates how early intervention programme benefits may operate beyond the traditional parameters of child developmental progress by exploring family outcomes too. Sameroff and Fiese's (1990) model of transactional developmental regulation is applied to provide a conceptual framework for the evaluation of an interdisciplinary intervention programme for pre-school children with motor impairments. Qualitative and quantitative methods were combined by using standardized assessment of child progress and interviews. Fifteen children, 11 mothers and five staff participated in the study. Triangulation of data was carried out to obtain evidence of remediation (child progress), re-education (parent learning) and redefinition (changes in parental perceptions and expectations of their child's difficulties that allowed parents to apply usual, rather than special, caregiving practices) as described in Sameroff and Fiese's model. Findings point to the effectiveness of the programme as indicated by evidence of child developmental progress, parental re-education and redefinition. The study suggests that redefinition may be at least as important a programme outcome as remediation or re-education, challenging established notions of the goals of pre-school programmes for disabled children. Implications of a broader-based, family-focused approach are discussed.     

The use of anti-D to improve post-transfusion platelet response: a randomized trial

Patients undergoing induction chemotherapy for acute leukaemia often become refractory to platelet transfusions. Increased clearance of transfused platelets due to alloimmune destruction has been identified as one of the primary mechanisms contributing to this refractory state. We performed a double-blind randomized trial to determine whether the administration of anti-D to Rh-positive individuals could prevent the refractory state and improve post-transfusion platelet response. Rh-positive patients with acute leukaemia undergoing induction chemotherapy and requiring platelet transfusions were allocated to weekly intravenous anti-D (20 micrograms/kg) or placebo. Platelets and red cell concentrates were administered according to standardized transfusion guidelines. Outcome measures included platelet transfusion utilization, red cell utilization, platelet recovery 18-24 h post-infusion, and the percentage of patients refractory to platelet transfusion. There were 43 patients studied: 21 received anti-D and 22 saline placebo. The mean number of platelet concentrates required per day of observation was 0.59 (SD 0.22) in the anti-D group and 0.61 (SD 0.22) in the placebo group, P = 0.86. No difference was detected between groups in terms of platelet recovery post-infusion, refractoriness to platelet transfusion or frequency of infection (P = 0.97). Red cell concentrate utilization was significantly increased in the anti-D group compared to the placebo group, 0.58 units per day versus 0.37 units per day respectively, P = 0.005. We conclude that the use of anti-D did not improve post-transfusion platelet response in Rh positive patients with acute leukaemia, but did result in an increased need for red cell transfusion.     

Family physicians'' utilization of a brief smoking cessation program following reinforcement contact after training: a randomized trial

Viral infections may induce an acquired form of immunodeficiency, generally lasting a few weeks. In the more severe form, such as HIV infection, the immunodeficiency is permanent. Programmed death of T cells represents one of the mechanisms by which HIV determines the T cell functional impairment, finally resulting in the destruction of T cells. In this study, we evaluated whether an altered regulation of apoptosis was also implicated in the anergy associated with the common measles or varicella-zoster virus (VZV) infections in infancy. A spontaneous apoptosis of peripheral blood mononuclear cells was observed in children who had suffered from these infections as long as 6 mo after the acute disease. Apoptosis was demonstrated through analysis of cellular DNA content, morphologic evidence of cell nuclei shrinkage, and by analysis of DNA degradation. Stimulation of T cells through anti-CD4 MAb increased the number of apoptotic cells with a maximal effect 72 h after the stimulation. Our results suggest that apoptosis may account for the anergy that follows acute viral infections in infancy.     

Evaluation by a randomized trial of the usefulness of endoscopy after treatment of a flare-up of non-severe esophagitis

OBJECTIVES: The clinical usefulness of esophageal endoscopy at the end of a treatment of non-severe esophagitis due to gastro-esophageal reflux is unknown. The aim of this randomized trial was to compare two strategies for the management of non-severe esophagitis, one with endoscopy at the end of the initial treatment including a retreatment of persistent ulcerations (group 1) and one without final endoscopy (group 2). PATIENTS AND METHODS: Eligible patients had heartburn and endoscopically proved esophagitis, non-confluent or confluent erosions and must have been relieved of their heartburn after a 4 to 6 week treatment with H2 blockers or by proton pump inhibitor. When the ulcerations were healed in group 1 and immediately at the end of the initial treatment in group 2, a self-care treatment by sodium alginate was prescribed. A total of 369 patients were randomized, 178 in group 1, 191 in group 2. RESULTS: At 6 months, there was no difference in the percentage of patients with clinical and endoscopical success, 52% and 55% in group 1 versus 47% and 60% in group 2 respectively. In group 1, 29 patients (16%) needed another treatment than alginate versus 31 patients in group 2 (16%, NS). Among patients with endoscopy at 6 months, the percentage of patients with confluent erosions was 4% (5/140) and with non-confluent erosion 26% (37/140) in group 1 versus 6% (9/158) and 22% (34/158) in group 2 respectively (NS). The percentage of patients with at least one sick day related to reflux was 12% in group 1 versus 5% in group 2 (P = 0.03). There was no difference in pharmacy costs (331,40 vs 264,3 Francs). CONCLUSION: Endoscopic verification is not necessary in patients with non-severe esophagitis who have been clinically improved by an initial treatment by H2 blockers or proton pump inhibitor, even among patients with confluent esophageal erosions.     

Prevention of the extension of distal deep venous thrombosis. A randomized controlled trial with a 6-month follow-up

BACKGROUND: Deep venous thrombosis (DVT) of distal veins of the legs is important for its frequency and its potential proximal extension. The incidence of embolization in distal DVT is limited and treatment still undefined. METHODS: After diagnosing with duplex scanning a distal DVT patients were included in a 24-week follow-up. All subjects used elastic compression (stockings TED = thromboembolic deterrent) for 24 weeks after DVT. In the 4 groups the following prophylaxis for 8 weeks were used: A: oral anticoagulant (INR 2.5). B: subcutaneous calcium heparin 0.2 ml bid (8.00 and 20.00). C: subcutaneous calcium heparin (0.5 ml at 20.00). D was the control group (only elastic TED stockings). heparin 0.2 ml bid (5000 IU) and 0.5 ml once daily (12.500 IU) were used for individuals with weight range between 65 and 90 kg. No patient was admitted into hospitals. Initially 106 patients were included. There were 17 (9.6%) drop outs and after 8 weeks 177 patients completed the study. No pulmonary embolisation or side effects were observed. In one patient (control group) an important extension of the thrombus to the femoral and iliac veins was observed. RESULTS: The percentage of thrombus reduction was higher in the treatment groups than in controls (p < 0.05). No significant differences were found among the 3 treatment groups. At 8 weeks 88.6% of patients treated with oral anticoagulant showed improvement (stability/reduction in size of the thrombus; the percentage was 88.4% in subjects treated with subcutaneous heparin bid and 93.2% in those treated with a single dosage). In the control group thrombus increase was observed in 78.3% of patients (this difference was significant in comparison with the treatment groups; p < 0.05). At the 24-week control in 97.6% of patients in group A thrombosis was reduced/stable. This percentage was 97.7% in the ca-heparin double-dose group (B) and 100% in the single dose group (C), significantly lower than in group D (75%; p < 0.05). CONCLUSIONS: Results indicate that untreated subjects with distal DVT are at risk of thrombus extension. In this study treatments were clinically equivalent. However one single dose of subcutaneous heparin is as effective as the double dose, is better tolerated, does not require haematological monitoring and has a lower cost.