Treating hypertension in type II diabetic patients with device-guided breathing: a randomized controlled trial.

The objective of the study was to evaluate the efficacy of device-guided breathing to lower blood pressure (BP) in hypertensive type II diabetic patients. A randomized controlled trial was carried out in four urban family practice clinics in Israel. Non-insulin-dependent diabetic, hypertensive patients with uncontrolled BP, receiving antihypertensive therapy or those non-medicated were enrolled. Baseline characteristics of the 66 patients who completed the study (33 intervention and 33 control) were: 62% men, age 62+/-8 years (mean+/-s.d.); body mass index 29+/-5 kg/m2; systolic BP 148+/-11 mm Hg and diastolic BP 81+/-9 mm Hg. The intervention group used a device (RESPeRATE), which interactively guides the user towards slow and regular breathing by synchronizing respiration voluntarily to musical tones for 15 min daily for an 8-week period. The control group continued with their regular treatment. BP was measured in the clinic at baseline, after 4 weeks and at 8 weeks. Medication was unchanged for 4 weeks prior to and during the study period. The main outcome measure was the office BP change from baseline to the end of the 8-week period. BP was reduced in the treatment group (mean+/-s.e.) systolic -10.0+/-1.8 mm Hg and diastolic -3.6+/-1.3 mm Hg (P<0.0001 and P<0.01), but not in the controls +1.6+/-2.1 and -1.0+/-1.4 mm Hg P>0.4 and P>0.4, respectively. Test for between group difference P<0.0001 and P=0.08. The subjects were highly compliant with the treatment, performing 75% of the requested exercise sessions. Greater BP reduction was observed with increased compliance with device usage (P=0.01 and P=0.001). It is concluded that self-treatment with device-guided breathing at home for 8 weeks by non-insulin-dependent diabetic patients was associated with a substantial reduction in office systolic BP.

Early postoperative small bowel obstruction.

BACKGROUND: Early postoperative small bowel obstruction (EPSBO) is a distinct clinical entity that is often difficult to differentiate from postoperative ileus. METHODS: A literature search was performed for articles dealing with early postoperative small bowel obstruction using Medline and Google. RESULTS AND CONCLUSION: When bowel function does not return within 5 days after surgery, causes of persistent ileus should be excluded and treated. Most instances of mechanical EPSBO can be treated expectantly for at least 10-14 days with almost no risk of bowel strangulation. Some causes of obstruction (for example herniation at a laparoscopic trocar site) require early reintervention, whereas in other cases (such as radiation enteritis, carcinomatosis) reintervention may be deferred indefinitely. Many episodes of EPSBO resolve without the cause being elucidated.

Colonoscopy-assisted 'trephine' sigmoid colostomy.

Fecal diversion is often required to treat complex traumatic, malignant or inflammatory anorectal conditions. In such circumstances, the formation of a proximal, 'trephine' sigmoid colostomy would avoid the need for, and the associated morbidity of, a formal laparotomy. We describe a technique which combines intraoperative colonoscopy with a diverting, 'trephine' sigmoid colostomy, thereby helping the surgeon to identify the correct loop of bowel, to avoid inadvertent maturing of the wrong end of the divided colon, and to exclude intracolonic lesions.

Current practices in left-sided colonic emergencies: a survey of US gastrointestinal surgeons.

BACKGROUND: The paradigms in the surgical management of obstruction and perforation of the left colon - once considered absolute contraindications to primary resection and anastomosis - are changing. The aim of this survey was to poll American Gastrointestinal surgeons on their current approach to left colonic emergencies. METHODS: A questionnaire was sent to 500 US-based surgeons, randomly selected members from the membership list of the Society for Surgery of the Alimentary Tract. It surveyed the surgeons on how they would approach 'good-risk' and 'poor-risk' patients with left colonic obstruction or perforation. RESULTS: 215 (43%) surgeons responded to the questionnaire; 180 fully completed questionnaires (36%) were analyzed. Sigmoid obstruction: 96 responders (53%) selected a one-stage procedure in 'good-risk' patients; 78 preferred sigmoid resection with (n = 46) or without (n = 32) 'on-table' colonic lavage and 18 opted for a subtotal colectomy and ileo-rectal anastomosis. Most (94%) responders preferred a staged procedure in 'high-risk' patients: a Hartmann resection (n = 120) or a transverse colostomy (n = 46). Sigmoid diverticular perforation: only one third of the responders recommended a one-stage procedure in 'good-risk' patients: 58 would perform a sigmoidectomy with (n = 19) or without (n = 39) 'on-table' colonic lavage; only two opted for subtotal colectomy with ileo-rectal anastomosis. In 'high-risk' patients most surgeons opted for a Hartmann's (88%) procedure or a diverting colostomy (7%). CONCLUSIONS: This survey suggests that a half and one-third of the responders would perform a one-stage resection and anastomosis in 'good-risk' patients with left colonic obstruction and perforation, respectively. In 'poor-risk' patients most responders would still opt for a staged procedure.

Biliary web--a rare cause of extrahepatic biliary obstruction.

A case of an isolated mucosal web of the common hepatic duct is presented. Such extrahepatic biliary webs are extremely rare causes of biliary obstruction, likely congenital in nature, but presenting in later life due to the initial patency of these webs in allowing bile drainage from the liver. The relevant literature is reviewed; diagnostic and therapeutic aspects are discussed.

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

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

Redundant surgical publications: tip of the iceberg?

BACKGROUND: A redundant publication is one which duplicates previous, simultaneous, or future publications by the same author or group or, alternatively, could have been combined with the latter into one paper. As there is no information about the extent of this problem in the surgical literature, we set out to assess the incidence, spectrum, and salient characteristics of redundant publications in 3 leading surgical journals. METHODS: Original articles (excluding reviews, editorials, abstracts, and letters) published during 1998 in the journals Surgery, The British Journal of Surgery, and Archives of Surgery were searched by using the on-line search engine PUBMED. Each original article was scrutinized to identify redundancy by combining the names of the first, second, and last authors with a few key words from the title. Papers were defined as "suspected" redundant publications if they were found to address the same topic as the "index" article and shared some or most of the elements of methodology, results, or conclusions. The full versions of all suspected papers were retrieved and compared with the index articles. A grading system was developed to define several types of redundant publications: A. "dual"; B. "potentially dual"; C. "salami-slicing." RESULTS: A total of 660 articles were screened. There were 92 index articles (14%) leading to 147 suspected papers found in other journals, representing some potential form of a redundant publication. The vast majority of suspected papers were published within approximately a year of the index paper and were not cited by the latter. Most (69%) of the suspected papers were also published in surgical journals. Only 12 (8.1%) appeared in, or originated from, a "local-foreign" journal. Twenty (13.6%) of the suspected papers met the criteria for dual publications, 50 (34%) for potentially dual publications, and 77 (52.4%) were considered products of salami-slicing. CONCLUSIONS: Almost 1 in every 6 original articles published in leading surgical journals represents some form of redundancy. Current on-line search technology provides an effective tool for identifying and tracing such publications, but it is not used routinely as part of the peer review process. Redundancies occur in several well-defined patterns; the phenomenon is widespread, and it cuts across the entire spectrum of surgeons in the United States and abroad. Redundant publications must be recognized not as a mere nuisance but as a real threat to the quality and intellectual impact of surgical publishing.

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

GENERAL DESIGN: Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). A randomised, placebo controlled, double-blinded, single-centre study is performed at an University Hospital (n = 40 patients for each group). This part presents the course of the individual patient and a complication algorithm for the management of anastomotic leakage and quality management. OBJECTIVE: In part three of the protocol, the three major sections include: The course of the individual patient using a comprehensive graphic display, including the perioperative period, hospital stay and post discharge outcome. A center based clinical practice guideline for the management of the most important postoperative complication--anastomotic leakage--including evidence based support for each step of the algorithm. Data management, ethics and organisational structure. CONCLUSIONS: Future studies with immune modifiers will also fail if not better structured (reduction of variance) to achieve uniform patient management in a complex clinical scenario. This new type of a single-centre trial aims to reduce the gap between animal experiments and clinical trials or--if it fails--at least demonstrates new ways for explaining the failures.

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

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

Breathing-control lowers blood pressure.

We hypothesise that routinely applied short sessions of slow and regular breathing can lower blood pressure (BP). Using a new technology BIM (Breathe with Interactive Music), hypertensive patients were guided towards slow and regular breathing. The present study evaluates the efficacy of the BIM in lowering BP. We studied 33 patients (23M/10F), aged 25-75 years, with uncontrolled BP. Patients were randomised into either active treatment with the BIM (n = 18) or a control treatment with a Walkman (n = 15). Treatment at home included either musically-guided breathing exercises with the BIM or listening to quiet music played by a Walkman for 10 min daily for 8 weeks. BP and heart rate were measured both at the clinic and at home with an Omron IC BP monitor. Clinic BP levels were measured at baseline, and after 4 and 8 weeks of treatment. Home BP measurements were taken daily, morning and evening, throughout the study. The two groups were matched by initial BP, age, gender, body mass index and medication status. The BP change at the clinic was -7.5/-4.0 mm Hg in the active treatment group, vs -2.9/-1.5 mm Hg in the control group (P = 0.001 for systolic BP). Analysis of home-measured data showed an average BP change of -5.0/-2.7 mm Hg in the active treatment group and -1.2/+0.9 mm Hg in the control group. Ten out of 18 (56%) were defined as responders in the active treatment group but only two out of 14 (14%) in the control group (P = 0.02). Thus, breathing exercise guided by the BIM device for 10 min daily is an effective non-pharmacological modality to reduce BP.

Treating hypertension with a device that slows and regularises breathing: a randomised, double-blind controlled study.

OBJECTIVE: To examine the efficacy of a new device, which slows and regularises breathing, as a non-pharmacological treatment of hypertension and thus to evaluate the contribution of breathing modulation in the blood pressure (BP) reduction. DESIGN AND SETTING: Randomised, double-blind controlled study, carried out in three urban family practice clinics in Israel. PATIENTS: Sixty-five male and female hypertensives, either receiving antihypertensive drug therapy or unmedicated. Four patients dropped out at the beginning of the study. INTERVENTION: Self treatment at home, 10 minutes daily for 8 consecutive weeks, using either the device (n = 32), which guides the user towards slow and regular breathing using musical sound patterns, or a Walkman, with which patients listened to quiet music (n = 29). Medication was unchanged 2 months prior to and during the study period. MAIN OUTCOME MEASURES: Systolic BP, diastolic BP and mean arterial pressure (MAP) changes from baseline. RESULTS: BP reduction in the device group was significantly greater than a predetermined 'clinically meaningful threshold' of 10.0, 5.0 and 6.7 mm Hg for the systolic BP, diastolic BP and MAP respectively (P = 0.035, P = 0.0002 and P = 0.001). Treatment with the device reduced systolic BP, diastolic BP and MAP by 15.2, 10.0 and 11.7 mm Hg respectively, as compared to 11.3, 5.6 and 7.5 mm Hg (P = 0.14, P = 0.008, P = 0.03) with the Walkman. Six months after treatment had stopped, diastolic BP reduction in the device group remained greater than the 'threshold' (P < 0.02) and also greater than in the walkman group (P = 0.001). CONCLUSIONS: The device was found to be efficacious in reducing high BP during 2 months of self-treatment by patients at home. Breathing pattern modification appears to be an important component in this reduction.

Ethiopian parents' perception of their children's health: a focus group study of immigrants to Israel.

BACKGROUND: The recent influx of Ethiopian immigrants to Israel has created challenges for healthcare workers. Qualitative research methods have proven to be of value in providing useful data in cross-cultural medical settings. OBJECTIVE: To learn about Ethiopian immigrants' perception of the health of their children. METHODS: Ethiopian parents of children under age 3 registered with a family medicine clinic in Jerusalem were invited to participate in two focus groups. Transcripts of the group discussions were analyzed to reveal themes relating to children's health. RESULTS: Analysis of the transcripts revealed five themes relating to the health of children in two domains: the intra-familial and the extra-familial. Specific themes that emerged in the intra-familial domain were the role of traditional medicine, gender-specific roles in child care, and decision-making in seeking extra-familial medical help. Themes in the extra-familial domain were recognition of illness and the meaning of symptoms, and notions of prevention and resistance to illness. The collected data found application in the daily clinical work of the researchers and enriched understanding of their patients. CONCLUSIONS: Ethiopian immigrants to Israel share special perceptions of their children's health that differ from prevailing beliefs in Israel. Focus groups provide health workers with a wealth of data on these beliefs that will enable them to offer more culturally sensitive care.

Bilateral hydroureter and hydronephrosis causing renal failure due to a procidentia uteri: a case report.

We report a case of complete uterine prolapse that resulted in bilateral hydroureter, hydronephrosis, and renal dysfunction. The nonoperative reduction of the prolapse with a vaginal pessary reversed the obstructive uropathy and ameliorated renal function. The lower urinary tract should be imaged in patients with complete uterine prolapse. If present, obstructive uropathy should be relieved by the reduction of the prolapse before irreversible renal damage occurs.

Intractable obstructive shock as a result of isolated cardiac metastases: a case report.

Cardiac metastases are uncommon and difficult to diagnose clinically; thus, they are most often found only at autopsy. Here we present a case of isolated right atrial cardiac metastasis found 7 weeks after the resection of the primary tumor, which was an adenocarcinoma of the lung. The patient presented with intractable obstructive shock, caused by a ball-valve effect of the atrial lesion that prevented forward blood flow from the right atrium. Computed tomography (CT) scans and echocardiograms failed to detect the lesion, and the patient died 2 weeks later. An autopsy revealed a large, isolated right atrial metastatic adenocarcinoma.