Home visits as part of a new care pathway (iAID) to improve quality of care and quality of life in ostomy patients: a cluster-randomized stepped-wedge trial.

AIM: Morbidity in patients with an ostomy is high. A new care pathway, including perioperative home visits by enterostomal therapists, was studied to assess whether more elaborate education and closer guidance could reduce stoma-related complications and improve quality of life (QoL), at acceptable cost. METHOD: Patients requiring an ileostomy or colostomy, for any inflammatory or malignant bowel disease, were included in a 15-centre cluster-randomized 'stepped-wedge' study. Primary outcomes were stoma-related complications and QoL, measured using the Stoma-QOL, 3 months after surgery. Secondary outcomes included costs of care. RESULTS: The standard pathway (SP) was followed by 113 patients and the new pathway (NP) by 105 patients. Although the overall number of stoma-related complications was similar in both groups (SP 156, NP 150), the proportion of patients experiencing one or more stoma-related complications was significantly higher in the NP (72% vs 84%, risk difference 12%; 95% CI: 0.3-23.3%). Although in the NP more patients had stoma-related complications, QoL scores were significantly better (P < 0.001). In the SP more patients required extra care at home for their ostomy than in the NP (60.6% vs 33.7%, respectively; risk difference 26.9%, 95% CI: 13.5-40.4%). Stoma revision was done more often in the SP (n = 11) than in the NP (n = 2). Total costs in the SP did not differ significantly from the NP. CONCLUSION: The NP did not reduce the number of stoma-related complications but did lead to improved quality of care and life, against similar costs. Based on these results the NP, including perioperative home visits by an enterostomal therapist, can be recommended.

A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer.

BACKGROUND: Rectal cancer surgery is accompanied with high morbidity and poor long term functional outcome. Screening programs have shown a shift towards more early staged cancers. Patients with early rectal cancer can potentially benefit significantly from rectal preserving therapy. For the earliest stage cancers, local excision is sufficient when the risk of lymph node disease and subsequent recurrence is below 5 %. However, the majority of early cancers are associated with an intermediate risk of lymph node involvement (5-20 %) suggesting that local excision alone is not sufficient, while completion radical surgery, which is currently standard of care, could be a substantial overtreatment for this group of patients. METHODS/STUDY DESIGN: In this multicentre randomised trial, patients with an intermediate risk T1-2 rectal cancer, that has been locally excised using an endoluminal technique, will be randomized between adjuvant chemo-radiotherapylimited to the mesorectum and standard completion total mesorectal excision (TME). To strictly monitor the risk of locoregional recurrence in the experimental arm and enable early salvage surgery, there will be additional follow up with frequent MRI and endoscopy. The primary outcome of the study is three-year local recurrence rate. Secondary outcomes are morbidity, disease free and overall survival, stoma rate, functional outcomes, health related quality of life and costs. The design is a non inferiority study with a total sample size of 302 patients. DISCUSSION: The results of the TESAR trial will potentially demonstrate that adjuvant chemoradiotherapy is an oncological safe treatment option in patients who are confronted with the difficult clinical dilemma of a radically removed intermediate risk early rectal cancer by polypectomy or transanal surgery that is conventionally treated with subsequent radical surgery. Preserving the rectum using adjuvant radiotherapy is expected to significantly improve morbidity, function and quality of life if compared to completion TME surgery. TRIAL REGISTRATION: NCT02371304 , registration date: February 2015.

Conversion of failed laparoscopic adjustable gastric banding to Roux-en-Y gastric bypass is safe as a single-step procedure.

BACKGROUND: Several different procedures have been proposed as a revisional procedure for treatment of failed laparoscopic adjustable gastric banding (LAGB). Laparoscopic Roux-en-Y gastric bypass (LRYGB) has been advocated as the procedure of choice for revision. In this study, we compare the single- and two-step approaches for the revision of failed LAGB to LRYGB. METHOD: All patients who underwent bariatric surgery were included in a prospective database. For the purpose of this study, patients who underwent revisional surgery from LAGB to LRYGB were selected. Records for individual patients were completed by data review. Complication rates and weight development were recorded until 2 years postoperatively. Data were compared between both procedures and with complications rates reported in literature. RESULTS: Revisional gastric bypass surgery was performed in 257 patients. This was done as a planned single-step procedure in 220 (86 %) patients without indications for acute band removal and in 32 patients as a planned 2 step procedure. Five patients were planned as a single-step procedure but were intraoperatively converted to a 2-step procedure based on poor pouch tissue quality. No postoperative mortality occurred in both groups. No differences in early major morbidity and stricture formation were seen between the two groups. Gastric ulceration was more frequently observed after 2-steps procedure (8.5 vs. 1.7 %, p < 0.05). In comparison with data reported in literature, the single-step procedure had similar to lower complication rates. Percentage excess weight loss two years after revisional gastric bypass procedure was, respectively, 53 versus 67 % (p = 0.147) for single- and two-step procedure. CONCLUSION: In patients without indications for acute band removal, the planned conversion of gastric banding to Roux-Y gastric bypass can be safely done in a single-step procedure without increase in morbidity and no difference in postoperative weight loss.

Effective and efficient learning in the operating theater with intraoperative video-enhanced surgical procedure training.

BACKGROUND: INtraoperative Video Enhanced Surgical procedure Training (INVEST) is a new training method designed to improve the transition from basic skills training in a skills lab to procedural training in the operating theater. Traditionally, the master-apprentice model (MAM) is used for procedural training in the operating theater, but this model lacks uniformity and efficiency at the beginning of the learning curve. This study was designed to investigate the effectiveness and efficiency of INVEST compared to MAM. METHODS: Ten surgical residents with no laparoscopic experience were recruited for a laparoscopic cholecystectomy training curriculum either by the MAM or with INVEST. After a uniform course in basic laparoscopic skills, each trainee performed six cholecystectomies that were digitally recorded. For 14 steps of the procedure, an observer who was blinded for the type of training determined whether the step was performed entirely by the trainee (2 points), partially by the trainee (1 point), or by the supervisor (0 points). Time measurements revealed the total procedure time and the amount of effective procedure time during which the trainee acted as the operating surgeon. Results were compared between both groups. RESULTS: Trainees in the INVEST group were awarded statistically significant more points (115.8 vs. 70.2; p < 0.001) and performed more steps without the interference of the supervisor (46.6 vs. 18.8; p < 0.001). Total procedure time was not lengthened by INVEST, and the part performed by trainees was significantly larger (69.9 vs. 54.1 %; p = 0.004). CONCLUSIONS: INVEST enhances effectiveness and training efficiency for procedural training inside the operating theater without compromising operating theater time efficiency.

The learning effect of intraoperative video-enhanced surgical procedure training.

BACKGROUND: The transition from basic skills training in a skills lab to procedure training in the operating theater using the traditional master-apprentice model (MAM) lacks uniformity and efficiency. When the supervising surgeon performs parts of a procedure, training opportunities are lost. To minimize this intervention by the supervisor and maximize the actual operating time for the trainee, we created a new training method called INtraoperative Video-Enhanced Surgical Training (INVEST). METHODS: Ten surgical residents were trained in laparoscopic cholecystectomy either by the MAM or with INVEST. Each trainee performed six cholecystectomies that were objectively evaluated on an Objective Structured Assessment of Technical Skills (OSATS) global rating scale. Absolute and relative improvements during the training curriculum were compared between the groups. A questionnaire evaluated the trainee's opinion on this new training method. RESULTS: Skill improvement on the OSATS global rating scale was significantly greater for the trainees in the INVEST curriculum compared to the MAM, with mean absolute improvement 32.6 versus 14.0 points and mean relative improvement 59.1 versus 34.6% (P=0.02). CONCLUSION: INVEST significantly enhances technical and procedural skill development during the early learning curve for laparoscopic cholecystectomy. Trainees were positive about the content and the idea of the curriculum.

Optimal ergonomics for laparoscopic surgery in minimally invasive surgery suites: a review and guidelines.

BACKGROUND: With minimally invasive surgery (MIS), a man-machine environment was brought into the operating room, which created mental and physical challenges for the operating team. The science of ergonomics analyzes these challenges and formulates guidelines for creating a work environment that is safe and comfortable for its operators while effectiveness and efficiency of the process are maintained. This review aimed to formulate the ergonomic challenges related to monitor positioning in MIS. Background and guidelines are formulated for optimal ergonomic monitor positioning within the possibilities of the modern MIS suite, using multiple monitors suspended from the ceiling. METHODS: All evidence-based experimental ergonomic studies conducted in the fields of laparoscopic surgery and applied ergonomics for other professions working with a display were identified by PubMed searches and selected for quality and applicability. Data from ergonomic studies were evaluated in terms of effectiveness and efficiency as well as comfort and safety aspects. Recommendations for individual monitor positioning are formulated to create a personal balance between these two ergonomic aspects. RESULTS: Misalignment in the eye-hand-target axis because of limited freedom in monitor positioning is recognized as an important ergonomic drawback during MIS. Realignment of the eye-hand-target axis improves personal values of comfort and safety as well as procedural values of effectiveness and efficiency. CONCLUSIONS: Monitor position is an important ergonomic factor during MIS. In the horizontal plain, the monitor should be straight in front of each person and aligned with the forearm-instrument motor axis to avoid axial rotation of the spine. In the sagittal plain, the monitor should be positioned lower than eye level to avoid neck extension.

Interoperative efficiency in minimally invasive surgery suites.

BACKGROUND: Performing minimally invasive surgery (MIS) in a conventional operating room (OR) requires additional specialized equipment otherwise stored outside the OR. Before the procedure, the OR team must collect, prepare, and connect the equipment, then take it away afterward. These extra tasks pose a thread to OR efficiency and may lengthen turnover times. The dedicated MIS suite has permanently installed laparoscopic equipment that is operational on demand. This study presents two experiments that quantify the superior efficiency of the MIS suite in the interoperative period. METHODS: Preoperative setup and postoperative breakdown times in the conventional OR and the MIS suite in an experimental setting and in daily practice were analyzed. In the experimental setting, randomly chosen OR teams simulated the setup and breakdown for a standard laparoscopic cholecystectomy (LC) and a complex laparoscopic sigmoid resection (LS). In the clinical setting, the interoperative period for 66 LCs randomly assigned to the conventional OR or the MIS suite were analyzed. RESULTS: In the experimental setting, the setup and breakdown times were significantly shorter in the MIS suite. The difference between the two types of OR increased for the complex procedure: 2:41 min for the LC (p < 0.001) and 10:47 min for the LS (p < 0.001). In the clinical setting, the setup and breakdown times as a whole were not reduced in the MIS suite. Laparoscopic setup and breakdown times were significantly shorter in the MIS suite (mean difference, 5:39 min; p < 0.001). CONCLUSION: Efficiency during the interoperative period is significantly improved in the MIS suite. The OR nurses' tasks are relieved, which may reduce mental and physical workload and improve job satisfaction and patient safety. Due to simultaneous tasks of other disciplines, an overall turnover time reduction could not be achieved.

Ergonomic assessment of neck posture in the minimally invasive surgery suite during laparoscopic cholecystectomy.

BACKGROUND: With the expanding implementation of minimally invasive surgery, the operating team is confronted with challenges in the field of ergonomics. Visual feedback is derived from a monitor placed outside the operating field. This crossover trial was conducted to evaluate and compare neck posture in relation to monitor position in a dedicated minimally invasive surgery (MIS) suite and a conventional operating room. METHODS: Assessment of the neck was conducted for 16 surgeons, assisting surgeons, and scrub nurses performing a laparoscopic cholecystectomy in both types of operating room. Flexion and rotation of the cervical spine were measured intraoperatively using a video analysis system. A two-question visual analog scale (VAS) questionnaire was used to evaluate posture in relation to the monitor position. RESULTS: Neck rotation was significantly reduced in the MIS suite for the surgeon (p = 0.018) and the assisting surgeon (p < 0.001). Neck flexion was significantly improved in the MIS suite for the surgeon (p < 0.001) and the scrub nurse (p = 0.018). On the questionnaire, the operating room team scored their posture significantly higher in the MIS suite and also indicated fewer musculoskeletal complaints. CONCLUSIONS: The ergonomic quality of the neck posture is significantly improved in the MIS suite for the entire operating room team.

Laparoscopic vs open total mesorectal excision for rectal cancer: an evaluation of the mesorectum's macroscopic quality.

BACKGROUND: Next to surgical margins, yield of lymph nodes, and length of bowel resected, macroscopic completeness of mesorectal excision may serve as another quality control of total mesorectal excision (TME). In this study, the macroscopic completeness of laparoscopic TME was evaluated. METHODS: A series of 25 patients with rectal cancer were managed laparoscopically (LTME) and included in this study. The pathologic specimens of the LTME group were prospectively examined and matched with a historical group of resection specimens from patients who had undergone open TME (OTME). The two groups were matched for gender and type of resection (low anterior or abdominoperineal resection). Special care was given to the macroscopic judgment concerning the completeness of the mesorectum. RESULTS: A three-grade scoring system showed no differences between the LTME and OTME groups. CONCLUSION: The current study supports the hypothesis that oncologic resection using laparoscopic TME is feasible and adequate.

Case-control study of the muscular compartments and osseous strength in neurofibromatosis type 1 using peripheral quantitative computed tomography.

Skeletal anomalies are observed in neurofibromatosis type 1 (NF1), but the pathogenesis is unknown. Given that muscle mass is important in the development of the strength of bone, peripheral quantitative computed tomography (pQCT) was utilized to compare measurements of muscle compartments between NF1 individuals and controls. Forty individuals with NF1 (age 5-18 years) were evaluated. Cross-sectional measurements, at the 66% tibial site, were obtained using pQCT (XCT-2000, Stratec) and variables were compared to controls without NF1 ((age 5-18 years, N=380) using analysis-of-covariance controlling for age, height, Tanner stage, and gender. The NF1 cohort showed decreased total cross-sectional area [p<0.001], decreased muscle plus bone cross-sectional area [p<0.001], decreased muscle cross-sectional area [p<0.001], and decreased Stress Strain Index [p=0.010]. These data indicate that NF1 individuals have decreased muscle cross-sectional area and decreased bone strength than individuals without NF1.

Assessment of a new blood glucose strip: comparison of Visidex, Visidex II, and Chemstrip bG with Glucose Analyzer determination of blood glucose.

Chemical test strips for estimating blood glucose are reliable, rapid, and convenient when properly used. Ames (Miles Laboratories, Elkhart, Indiana) has recently introduced a new product, Visidex II, which does not require water for development. This study compares the Visidex II with its predecessor Visidex, an established test strip, the Bio-Dynamics Chemstrip bG (Boehringer-Mannheim, Indianapolis, Indiana), and plasma glucose as measured by standard laboratory methods. Determination of blood glucose by visual inspection by all chemical test strips gave an estimation of true plasma glucose, and was reliable in predicting those values that were hypo- and hyperglycemic, although Chemstrip bG tended to underestimate in the hypo- and euglycemic ranges. Visidex II is more convenient to use than Visidex and is equally reliable in estimating true plasma glucose. In addition, strips from 20 patient samples were read daily for 7 days. Reacted Chemstrip bG test strips began to deteriorate within 24 h, and showed a 27% decline in estimations by day 3. Reacted Visidex II strips were stable for 1 day, but then rapidly declined to 50% of the original estimation by day 4.

Comparison of Visidex and Chemstrip bG with Beckman Glucose Analyzer determination of blood glucose.

Chemical test strips for estimating blood glucose have been shown to be reliable, rapid, and convenient when properly used. This study compares a new product, the Ames Visidex (Miles Laboratories, Elkhart, Indiana), and an established product, the Bio-Dynamics Chemstrip bG (Boehringer-Mannheim, Indianapolis, Indiana) with plasma glucose as measured by standard laboratory methods. Determination of blood glucose by visual inspection of both chemical strips gave an estimation of true plasma glucose in the hypoglycemic and euglycemic ranges. Both strips were reliable in predicting those values that were hyperglycemic (greater than 180 mg/dl).

Disclosing HIV seropositivity to significant others.

OBJECTIVES: To examine gay men's patterns of self-disclosure of HIV seropositivity to friends, lovers, relatives and colleagues; to assess the effects of disclosure; and to identify reasons for not disclosing to particular individuals. DESIGN: Longitudinal questionnaire survey of gay men. METHODS: A total of 163 HIV-positive men participating in the AIDS Behavioral Research Project, a longitudinal study of San Francisco gay men, completed questionnaires about their self-disclosure patterns, health status, and psychological well-being. RESULTS: HIV-positive men were most likely to disclose their status to lovers and closest gay friends. Asymptomatic men were less likely to disclose to relatives and colleagues than symptomatic men. Friends and lovers were rated as responding more helpfully than relatives and colleagues. Men who perceived their significant others as responding more helpfully were less depressed and anxious currently and 1 year later. A variety of reasons were given for not disclosing, including not wanting to worry others, fear of discrimination, fear of disrupting relationships, and emotional self-protection. CONCLUSION: While disclosure can have advantages for both HIV-positive individuals and their significant others, HIV-positive individuals must be assured that the benefits of doing so will outweigh the potential costs.

Predictors of repeat HIV testing among gay and bisexual men.

OBJECTIVE: To examine the prevalence and predictors of repeat HIV testing. DESIGN, SETTING AND PARTICIPANTS: Cross-sectional data from two random household-based and bar-based samples of gay/bisexual men in two medium-size cities (Tucson, Arizona and Portland, Oregon) with substantial numbers of AIDS cases, in 1992 (n = 2602). MAIN OUTCOME MEASURE: The prevalence and predictors of repeat testing among men who reported being HIV-tested at least once but not being HIV-positive (n = 1583). RESULTS: In total, 51% of the sample had been tested three or more times, and 15% were tested more than once every 6 months. Men with higher risk were more likely to be repeatedly tested, although oral but not anal risk was a significant predictor of repeat testing in regression analyses. Men who did not know the HIV status of their primary partner were less likely to be repeatedly tested. Men who perceived that social norms favored secondary prevention, specifically adherence to medical recommendations for the treatment of HIV infection, and who communicated more often about testing were more likely to be repeatedly tested. CONCLUSIONS: Policy and clinical recommendations for repeat testing must be based on consideration of the complexity and multi-faceted nature of repeat testing. For some individuals, repeat testing may play a legitimate role in HIV prevention by reinforcing safe behavior and providing confirmation of HIV-negative status. However, for others repeat testing may indicate a need for different or more intensive interventions to encourage safe sex.

Characterization of the 130-bp repeat enhancer element of the rat ribosomal gene: functional interaction with transcription factor E1BF.

The 130-bp repetitive element (RE) of the rat rDNA (ribosomal RNA-encoding gene) intergenic spacer stimulated the synthesis of rRNA four- to sixfold, in comparison with that of the promoter alone, both in vivo and in vitro, when ligated to the rat rDNA promoter. The addition of increasing amounts of highly purified E1BF (enhancer-1 binding factor), which binds to the rat rDNA promoter and an upstream nonrepetitive enhancer element [Zhang and Jacob, Mol. Cell. Biol. 10 (1990) 5177-5186], to an in vitro transcription system resulted in enhancement of rDNA transcription from the recombinant plasmids containing the promoter or promoter-RE. However, E1BF-mediated stimulation of transcription under the influence of the RE continued at higher concentrations of E1BF than did the control transcription from the promoter alone. The binding affinity of E1BF for the RE was comparable to its affinity for the nonrepetitive far upstream enhancer element previously characterized in our laboratory. The sequences protected by E1BF in the RE differed from those protected by UBF (upstream control element-binding factor), a well characterized pol I transcription factor. These data suggest that E1BF belongs to a class of transcription factors which interact with the promoter and spacer cis-acting RE to modulate rDNA transcription.

RAI1 is a novel polyglutamine encoding gene that is deleted in Smith-Magenis syndrome patients.

The human chromosomal band 17p11.2 is a genetically unstable interval. It has been shown to be deleted in patients suffering from Smith-Magenis syndrome. Previous efforts of physical and transcriptional mapping in 17p11.2 and subsequent genomic sequencing of the candidate interval allowed the identification of new genes that might be responsible for the Smith-Magenis syndrome. In this report, one of these genes named RAI1, the human homologue of the mouse Rai1 gene, has been investigated for its contribution to the syndrome. Expression analysis on different human adult and fetal tissues has shown the existence of at least three splice variants. Moreover, the most interesting feature of the gene is the presence of a polymorphic CAG repeat coding for a polyglutamine stretch in the amino terminal domain of the protein.

Epidemiology of inguinal hernia in preterm neonates.

We have studied the epidemiology of inguinal hernias in preterm infants. Inguinal hernias occur with increased frequency in infants less than or equal to 32 weeks' gestational age or less than or equal to 1,250 g birth weight. Among infants less than or equal to 32 weeks' gestational age, intrauterine growth retardation significantly increases the risk for development of inguinal hernias, especially in male infants. Our data demonstrate a previously unrecognized association between neonatal inguinal hernia and intrauterine growth retardation.

Effect of trimethoprim/sulphamethoxazole and hyperbaric oxygen on experimental Spiroplasma mirum encephalitis.

This study was undertaken to determine the susceptibility of experimentally induced Spiroplasma mirum infection in the rat to trimethoprim/sulfamethoxazole (TMP/SMX) in combination with hyperbaric oxygen (HBO). One-day-old Fisher 344 rats were intracerebrally inoculated with the GT-48 strain of S. mirum and were exposed to regimens employed combined antibiotic and HBO treatments. The exclusive use of TMP/SMX produced a significant reduction in mortality (P less than 0.0001) and an absence of clinical signs of infection. HBO in combination with TMP/SMX showed similar effect on mortality and no evident clinical disease. The addition of HBO did result in a significant decrease in spiroplasma brain titres but was no more effective in preventing the spiroplasma-induced fatal microcystic encephalopathy than when the antibiotics were used alone. The exclusive use of HBO produced a catastrophic mortality rate in the spiroplasma-infected rats, which is contrary to the effect of HBO on conventional bacterial infections.

Lack of correlation of maternal human immunodeficiency virus infection with neonatal malformations.

A malformation syndrome has been proposed in infants with acquired immunodeficiency syndrome or acquired immunodeficiency syndrome-related complex secondary to congenital infection with human immunodeficiency virus (HIV) in the United States and Europe. To determine whether embryopathy is detectable in HIV-exposed African infants, 85 infants of HIV-seropositive mothers and 98 infants of HIV-seronegative mothers in Nairobi, Kenya, were examined for minor and major anomalous features shortly after birth. No mother used intravenous drugs. With the exception of growth failure no anomalous feature was associated with in utero HIV exposure. No increase in the number of anomalous features per infant was correlated with HIV, nor did any infant have the reported malformation syndrome. Thus in this population of African infants examination for anomalous features during the neonatal period failed to identify those infants with fetal exposure to HIV.