Telemedicine in postoperative follow-up of STOMa PAtients: a randomized clinical trial (the STOMPA trial).

BACKGROUND: A stoma has severe impact on the patient's quality of life (QoL). Postoperative home community follow-up by teleconsultation (TC) and stoma nurses may reduce the burden of travel and improve QoL. METHODS: A university hospital and five district medical centres participated. Patients with a stoma were randomized to follow-up by either TC (intervention) or hospital (control). Stoma nurses performed the clinical examination at the TC studio, aided remotely by hospital nurses and surgeons. The primary endpoint was the EQ-5D™ index score; secondary endpoints were the Stoma Quality-of-Life Scale, the OutPatient Experiences Questionnaire, and use of hospital resources. RESULTS: A total of 110 patients were randomized to hospital (58 patients) or TC (52) follow-up; 64 patients (hospital 38, TC 26) were followed for more than 12 months and 246 consultations (hospital 151, TC 95) were performed. There were no differences in QoL: EQ-5D™ index score (P = 0·301) and EQ-5D™ visual analogue scale (VAS) score (P = 0·775); Work/Social Function (P = 0·822); Sexuality/Body Image (P = 0·253) and Stoma Function (P = 0·074). Hospital follow-up performed better for organization of care (staff collaboration, P = 0·004; met same persons, P = 0·003) and communication (surgeon understandable, P < 0·001; surgeon caring P = 0·003). TC did not increase the number of hospital consultations (P = 0·684) and reduced the number of journeys of more than 8 h (P = 0·007). CONCLUSION: Telemedicine follow-up by stoma nurses did not improve the QoL of patients, but decreased the readmission rate and burden of travel. Registration number NCT01600508 ( https://www.clinicaltrials.gov).

ANTECEDENTES: Un estoma tiene un gran impacto en la calidad de vida (quality of life, QoL) del paciente. El seguimiento postoperatorio comunitario a nivel del hogar del paciente por Tele Consulta (TC) y enfermeras especializadas en estomas puede reducir la carga de viaje y mejorar la calidad de vida. MÉTODOS: Un hospital universitario y cinco centros médicos de distrito participaron en el estudio. Los pacientes con estoma fueron asignados al azar para el seguimiento mediante TC (intervención) o en el hospital (control). Las enfermeras de estomas realizaron el examen clínico en el estudio de TC, con la ayuda remota de enfermeras y cirujanos del hospital. El objetivo final primario fue la puntuación del índice EQ-5D, los objetivos finales secundarios fueron la Escala de Calidad de Vida del Estoma, el Cuestionario de Experiencias Ambulatorias y la utilización de recursos hospitalarios. Se utilizaron análisis de la varianza (ANOVA) para comparar los grupos. RESULTADOS: Un total de 110 pacientes fueron asignados al azar para el seguimiento en el hospital (n = 58) o por TC (n = 52), 54 pacientes (hospital n = 38, TC n = 26) fueron seguidos durante > 12 meses; se realizaron 245 consultas (hospital n = 151; TC n = 94). No hubo diferencias en la QoL; puntuación del índice EQ-5D (P = 0,30); escala analógica visual (P = 0,77); trabajo y función social (P = 0,82); sexualidad y cuerpo (P = 0,25) y función del estoma (P = 0,07). El seguimiento hospitalario funcionó mejor en la organización de la atención (colaboración del personal P < 0,01; seguimiento por la misma persona P < 0,01), comunicación (cirujano comprensible/afectuoso, P < 0,01). La TC no aumentó las consultas hospitalarias (P = 0,68) y redujo > 8 horas de viaje (P < 0,01). CONCLUSIÓN: El seguimiento por telemedicina realizado por enfermeras especializadas en estomas no mejoró la QoL de los pacientes, pero disminuyó los reingresos y la carga de los viajes.

Sacral neuromodulation for combined faecal and urinary incontinence following obstetric anal sphincter injury.

AIM: The aim of this study was to investigate the efficacy of sacral neuromodulation (SNM) in the treatment of faecal incontinence and concomitant urinary incontinence in women with a history of obstetric anal sphincter injury (OASIS). METHOD: In this prospective study, consecutive women with faecal incontinence following OASIS accepted for SNM were screened for concomitant urinary incontinence. The primary outcome was the change in urinary incontinence score on the International Consultation on Incontinence Questionnaire for Urinary Incontinence, Short Form (ICIQ-UI-SF), between baseline and 12 months. Secondary outcomes included the change in St Mark's score, sexual function and quality of life, change in grade of urinary incontinence and disappearance of urgency. RESULTS: From March 2012 to September 2014, 39 women with combined faecal incontinence and urinary incontinence received SNM. Thirty-seven women were available for analysis after 12 months. The mean reduction in the ICIQ-UI-SF score between the baseline and 12 months was 5.8 (95% CI 3.7-8.0, P < 0.001). ICIQ-UI-SF was reduced in 29 (78%) women, urinary incontinence resolved in 13/37 (35%, 95% CI 20%-50%) patients, and urgency disappeared in 14/33 (42%, 95% CI 26%-59%). The mean reduction in the St Mark's score was 10.6 (95% CI 8.6-12.7, P < 0.001). Disease-specific quality of life, Euroqual 5-dimension visual analogue scale (EQ-5D VAS) and several areas of sexual function changed significantly for the better. CONCLUSION: More than three-quarters of the women with combined faecal and urinary incontinence following OASIS reported a successful outcome with reduction in ICIQ-UI-SF at 12 months after SNM.

Sacral neuromodulation compared with injection of bulking agents for faecal incontinence following obstetric anal sphincter injury - a randomized controlled trial.

AIM: The purpose of this trial was to compare the effectiveness of sacral neuromodulation (SNM) with a submucosal injection of collagen (Permacol®) in women with faecal incontinence following obstetric anal sphincter injury (OASIS). METHOD: This single-blinded randomized controlled trial at two hospital units in Norway included women with faecal incontinence following OASIS. Eligible women who had had a successful percutaneous nerve evaluation were randomly assigned to SNM or Permacol®. The primary outcome was the difference in the St Mark's incontinence score between baseline and 6 months. Secondary outcomes were changes in the disease-specific quality of life (FIQL) and urinary incontinence (ICIQ-UI-SF) scores. RESULTS: Fifty-eight women were randomly assigned to SNM (n = 30) and Permacol® (n = 28). The reduction in the St Mark's score between baseline and 6 months was 11.2 (SD 5.3) in the SNM group vs 2.3 (SD 5.0) in the Permacol® group, resulting in a difference of 8.9 (95% CI: 6.1-11.7, P < 0.0001). The differences in the four scales of FIQL (lifestyle, coping, depression, embarrassment) were 0.90 (95% CI: 0.50-1.30, P < 0.001), 1.05 (0.62-1.47, P < 0.001), 0.52 (95% CI: 0.16-0.87, P = 0.005) and 0.95 (95% CI: 0.50-1.40, P < 0.001), respectively, in favour of SNM. The difference in the ICIQ-UI-SF was 5.0 (95% CI: 1.97-8.02, P = 0.002) in favour of SNM. There were nine minor adverse events in the SNM group compared with seven in the Permacol® group (P = 0.77). CONCLUSION: SNM was superior to Permacol® in terms of reduction of St Mark's score, ICIQ-UI-SF and the change of the FIQL in women with faecal incontinence following OASIS.

Sacral neuromodulation for faecal incontinence following obstetric sphincter injury - outcome of percutaneous nerve evaluation.

AIM: The purpose of this study was to assess the efficacy of percutaneous nerve evaluation (PNE) in women with faecal incontinence (FI) following obstetric anal sphincter injury and to relate the outcomes to baseline factors, with special emphasis on the extent of the sphincter defect. METHOD: This was a prospective study at a tertiary colorectal referral unit at the University Hospital of North Norway conducted from 2012 to 2014. Sixty-three women underwent a 3-week PNE using a tined lead and the Verify® external neurostimulator. The primary outcome was efficacy, defined as the percentage reduction in weekly FI episodes, and patients with a reduction of 50% or more were defined as responders. Baseline factors affecting the primary outcome were explored. Sphincter defects were classified with a validated three-dimensional endoanal ultrasound defect score. RESULTS: Fifty-six (89%) of the 63 women were responders with a reduction in weekly FI episodes of 94.5%, from a median (interquartile range) of 4.8 (2.0-11.0) to 0.5 (0-2.0) (P < 0.001). Twenty-nine (52%) reported no weekly FI episodes, and urgency episodes disappeared in 18 (32%). In the multivariable linear regression model, efficacy was related to concomitant urinary incontinence (P = 0.04), body mass index (BMI) (P = 0.03) and pain during PNE (P = 0.046) but not to the extent of the sphincter defect (P = 0.1). Responders had a higher St Mark's score than nonresponders (P = 0.046). CONCLUSIONS: The vast majority of women had successful PNE tests. Responders had higher baseline St Mark's scores than nonresponders. Efficacy was related to concomitant urinary incontinence, BMI and pain, not to the extent of the sphincter defect.

Metastatic spread pattern after curative colorectal cancer surgery. A retrospective, longitudinal analysis.

OBJECTIVE: The most common sites of colorectal cancer (CRC) recurrence are the local tissues, liver or lungs. The objective was to identify risk factors associated with the primary CRC tumor and cancer recurrence in these anatomical sites. METHODS: Retrospective, longitudinal analyses of data on CRC survivors. Multivariable Cox regression analysis was performed to examine the association between possible cofounders with recurrence to various anatomical sites. RESULTS: Data for 10,398CRC survivors (tumor location right colon=3870, left colon=2898, high rectum=2569, low rectum=1061) were analyzed; follow up time was up to five years. Mean age at curative surgery was 71.5 (SD 11.8) years, 20.2% received radio-chemotherapy, stage T3 (64.4%) and N0 (65.1%) were most common. Overall 1632 (15.7%) had cancer recurrence (Isolated liver n=412, 3,8%; isolated lung n=252, 2,4%; isolated local n=223, 2.1%). Risk factors associated with recurrent CRC were identified, i.e. isolated liver metastases (male: Adjusted Hazard Ratio (AHR) 1,45; colon left: AHR 1,63; N2 disease: AHR 3,35; T2 disease: AHR 2,82), isolated lung metastases (colon left: AHR 1,53; rectum high: AHR 2,48; rectum low: AHR 2,65; N2 disease 3,76), and local recurrence (glands examined<12: AHR 1,51; CRM <3mm: AHR 1,60; rectum high: AHR 2,15; N2 disease: AHR 2,58) (all p values <0001). CONCLUSION: Our study finds that the site of the primary CRC tumor is associated with location of subsequent metastasis. Left sided colon cancers have increased risk of metastatic spread to the liver, whereas rectal cancers have increased risk of local recurrence and metastatic spread to the lungs. These results, in combination with other risk factors for CRC recurrence, should be taken into consideration when designing risk adapted post-treatment CRC surveillance programs.

System-based factors influencing intraoperative decision-making in rectal cancer by surgeons: an international assessment.

AIM: Sound surgical judgement is the goal of training and experience; however, system-based factors may also colour selection of options by a surgeon. We analysed potential organizational characteristics that might influence rectal cancer decision-making by an experienced surgeon. METHOD: One hundred and seventy-three international centres treating rectal cancer were invited to participate in a survey assessment of key treatment options for patients undergoing curative rectal-cancer surgery. The key organizational characteristics were analysed using multivariate methods for association with intra-operative surgical decision-making. RESULTS: The response rate was 71% (123 centres). Sphincter-saving surgery was more likely to be performed at university hospitals (OR=3.63, P=0.01) and by high-caseload surgeons (OR=2.77 P=0.05). A diverting stoma was performed more frequently in departments with clinical audits (OR=3.06, P=0.02), and a diverting stoma with coloanal anastomosis was more likely in European centres (OR=4.14, P=0.004). One-stage surgery was less likely where there was assessment by a multidisciplinary team (OR=0.24, P=0.02). Multivariate analysis showed that university hospital, clinical audit, European centre, multidisciplinary team and high caseload significantly impacted on surgical decision-making. CONCLUSION: Treatment variance of rectal cancer surgeons appears to be significantly influenced by organizational characteristics and complex team-based decision-making. System-based factors may need to be considered as a source of outcome variation that may impact on quality metrics.

Standards for reporting randomized controlled trials in medical informatics: a systematic review of CONSORT adherence in RCTs on clinical decision support.

INTRODUCTION: The Consolidated Standards for Reporting Trials (CONSORT) were published to standardize reporting and improve the quality of clinical trials. The objective of this study is to assess CONSORT adherence in randomized clinical trials (RCT) of disease specific clinical decision support (CDS). METHODS: A systematic search was conducted of the Medline, EMBASE, and Cochrane databases. RCTs on CDS were assessed against CONSORT guidelines and the Jadad score. RESULT: 32 of 3784 papers identified in the primary search were included in the final review. 181 702 patients and 7315 physicians participated in the selected trials. Most trials were performed in primary care (22), including 897 general practitioner offices. RCTs assessing CDS for asthma (4), diabetes (4), and hyperlipidemia (3) were the most common. Thirteen CDS systems (40%) were implemented in electronic medical records, and 14 (43%) provided automatic alerts. CONSORT and Jadad scores were generally low; the mean CONSORT score was 30.75 (95% CI 27.0 to 34.5), median score 32, range 21-38. Fourteen trials (43%) did not clearly define the study objective, and 11 studies (34%) did not include a sample size calculation. Outcome measures were adequately identified and defined in 23 (71%) trials; adverse events or side effects were not reported in 20 trials (62%). Thirteen trials (40%) were of superior quality according to the Jadad score (≥3 points). Six trials (18%) reported on long-term implementation of CDS. CONCLUSION: The overall quality of reporting RCTs was low. There is a need to develop standards for reporting RCTs in medical informatics.

Translation and validation of the Norwegian version of the fecal incontinence quality-of-life scale.

BACKGROUND AND AIM: Fecal incontinence quality-of-life scale (FIQLS) is a condition-specific health-related quality-of-life questionnaire composed of four scales: lifestyle, coping/behaviour, depression/self-perception and embarrassment. It has been widely translated and used as an evaluation tool for patients with fecal incontinence. Our aim was to translate the FIQLS, and to test some of the psychometric properties of the Norwegian version of the questionnaire. MATERIAL AND METHODS: The FIQLS was translated to Norwegian, and administered to a sample of 76 patients (73 women) who completed the questionnaire at baseline and again after three weeks. In addition, the severity of incontinence was assessed by phone-interviews (St. Mark's score). RESULTS: Three of four domains had good internal consistency in terms of Cronbach's alpha (.83-.91), the fourth (embarrassment) somewhat lower (.64). Stability over time was acceptable for all domains with ICC ranging from .74 to .86. Correlation with severity of incontinence (St. Mark's score) was medium to large for all four domains (-.46 to -.63) supporting the construct validity of the Norwegian FIQLS. CONCLUSION: The Norwegian version of fecal incontinence quality-of-life scale has been successfully translated and tested.

Endoscopic findings, Helicobacter pylori status, and dyspeptic complaints in vagotomized or medically treated peptic ulcer patients and healthy community controls.

BACKGROUND: The recommendation that Helicobacter pylori be eradicated in surgically treated peptic ulcer patients, regardless of complaints and ongoing ulceration, is controversial. To explore possible endoscopic changes associated with vagotomy and long-term acid suppression, the objectives of this study were to compare the endoscopic findings in the upper gastrointestinal mucosa in relation to H. pylori infection and dyspeptic symptoms in peptic ulcer patients treated surgically or medically. METHODS: Eighty-three randomly selected previously vagotomized peptic ulcer patients, 73 medically treated peptic ulcer patients, and a reference group of 88 healthy community controls underwent an endoscopic investigation. H. pylori infection was determined by culture growth augmented by histology. The endoscopist was blinded for the symptoms and the medical history of all subjects. RESULTS: H. pylori infection was found in 79% of the vagotomized patients, 75% of the medically treated patients, and 70% of the controls. No malignant lesions were found. Active peptic ulceration was the only endoscopic finding associated with abdominal complaints or H. pylori infection. More than half of subjects with normal endoscopy had H. pylori infection. CONCLUSIONS: No differences in endoscopic findings between the surgically and medically treated peptic ulcer patients could be found. The findings do not lend any support to H. pylori infection per se as an indication for eradication therapy in previously vagotomized peptic ulcer patients.

Abdominal and dyspeptic symptoms in patients with peptic ulcer treated medically or surgically.

BACKGROUND: Abdominal and dyspeptic complaints, which are prominent symptoms in patients with peptic ulceration, are commonly reported in the general population. There are few reports of follow-up study of peptic ulcer therapies in which clinical outcome has been compared with symptom reporting in community controls. METHODS: Three populations of patients with peptic ulcer disease (patients who had elective proximal gastric vagotomy (PGV), those having PGV for emergency indications and those receiving medical treatment with H2-receptor antagonists) were included in a questionnaire survey and compared with a group of randomly selected community controls. RESULTS: The vagotomized patients reported fewer abdominal complaints (P = 0.0003) and fewer dyspeptic complaints lasting for more than 1 week (P = 0.05) than those treated medically. There was no significant difference between vagotomized patients and community controls in the reporting of abdominal (P = 0.2) or dyspeptic (P = 0.9) complaints. CONCLUSION: Taking abdominal complaints as the endpoint for former peptic ulcer treatment, surgical treatment with PGV seemed to be superior to therapy with H2-receptor antagonists and produced an almost identical level of complaints to that seen in the community population.

Lansoprazole, amoxicillin, and clarithromycin triple therapy in vagotomized patients with dyspeptic complaints. A randomized, double-blind, placebo-controlled, clinical study without pretreatment diagnostic upper endoscopy.

BACKGROUND: The Maastricht Consensus Report advises that, in Helicobacter pylori-positive patients after surgery for peptic ulcer disease, H. pylori should be eradicated. The aim of the present study was to investigate the symptomatic response of H. pylori eradication in previously vagotomized peptic ulcer patients with persistent dyspeptic complaints. METHODS: The study was performed as a randomized, double-blind, placebo-controlled study. Pretreatment diagnostic upper endoscopy was omitted. All the results were submitted to intention-to-treat and efficacy analyses. RESULTS: We could not find any differences between the two groups with regard to intensity or frequency of upper abdominal pain, nausea, heartburn, or other abdominal symptoms during the 12-month follow-up. The triple therapy eradication rate was 88% at both 3- and 12-month controls. CONCLUSION: Vagotomized peptic ulcer patients with persistent dyspeptic complaints should undergo a diagnostic upper endoscopy to detect ulcer recurrence before H. pylori eradication treatment is considered.

[Outplacement of medical students in local hospitals]. / Utplassering av legestudenter i lokalsykehus.

The organisation and content of the training of medical students in practical and clinical skills at Norwegian universities is presented and discussed. Based on experience from Tromsø University, an increased use of local hospitals for training medical students in practical and clinical skills is planned for all universities in Norway.

The effects of plasma and albumin infusion on organ function and sepsis markers in experimental gram-negative sepsis.

To study the effects of early plasma versus albumin infusion on vital organ function and the appearance of central sepsis mediators in septic shock, three groups of anesthetized piglets (n = 28) were inoculated with live Eschericia coli. Group I received fresh frozen plasma, group II received albumin, whereas group III served as nontreated septic controls. Plasma-treated animals exhibited improved survival (p < .02) compared with controls, and improved organ function compared with both controls and albumin-treated animals. Plasma infusion was associated with increased levels of endotoxin (p < .02) and terminal complement complex (TCC) (p < .03), and persisting high levels of tumor necrosis factor (TNF). Following albumin infusion TNF levels decreased to baseline values (p < .01), whereas endotoxin and TCC levels did not change significantly. Our study shows a beneficial effect of early plasma infusion on survival and vital organ function in septic animals. The effect of plasma infusion on circulating levels of endotoxin, TNF, and TCC may be potentially deleterious in uncompensated stages of septic shock.

[Treatment of hypersecretory ileostomy, gastrostomy and fistula of the small intestine with the somatostatin analog octreotide]. / Behandling av hypersekretorisk ileostomi, gastrostomi og tynntarmsfistel med somatostatinanalogen oktreotid.

Hypersecretory stomas or fistulas are disabling conditions for the patients and a therapeutic challenge to the surgeons. Octreotide treatment is reported to reduce stoma output and the need for intravenous supplements. Octreotide treatment also reduces social disability due to postprandial hypersecretion causing frequent changes of stoma systems. Two patients with high output stomas and one patient with high output ileocutaneous fistula were treated with the somatostatin analogue octreotide. Reductions in stoma or fistula output from 48 to 62% were observed.

Repeated plasma therapy induces fatal shock in experimental septicemia.

Plasma therapy in severe septicemia, either as part of plasma exchange or alone, was evaluated in a model of lethal septic shock induced with live Escherichia coli in pigs. The following groups were studied: group I, septic animals treated with repeated plasma exchanges, n = 8; group II, nontreated septic controls, n = 8; group III, septic animals treated with repeated plasma infusions, n = 14; and group IV, nonseptic animals treated with repeated plasma infusions, n = 7. In the septic animals treated with plasma (groups I and III), a rapid fatal response was observed between 2 and 5 min after the start of plasma therapy, while the septic controls (group II) showed a progressively longer lasting septic shock. The nonseptic animals (group IV) were unaffected by the plasma infusions. Plasma levels of endotoxin above 2 ng/ml were associated with rapid death during plasma therapy. Ionized Ca2+ fell abruptly in this situation. This study indicates that commonly used plasma therapies (exchanges or transfusions) in septic animals may have acute deleterious effects. These effects may be explained by depletion of ionized calcium.

[Brodie's abscess]. / Brodies abscess.

Brodie's abscess is a localized subacute or chronic osteomyelitis independent of any known previous acute infection. The entity is often mistaken for a bone tumour. The diagnosis requires biopsy. The treatment is curettage, drainage and antibiotics for a minimum of six weeks. We describe the characteristics of Brodie's abscess and describe a patient with an illustrating history, but with an unusual localization of the abscess (osilium).

Tumor necrosis factor and interleukin 1 appearance in experimental gram-negative septic shock. The effects of plasma exchange with albumin and plasma infusion.

To study the effect of plasma removal vs plasma administration on the appearance of tumor necrosis factor (TNF) and interleukin 1 in septic shock, 24 anesthetized piglets were inoculated with live Escherichia coli. Plasma exchange with albumin was performed in one group. Fresh-frozen plasma was administered to a second group. A third group served as nontreated controls. Following plasma exchange, a reduction in both TNF and interleukin 1 levels occurred, whereas plasma infusion was followed by a decrease in TNF levels only. No significant differences were observed between the two treated groups with respect to survival or cardiovascular performance, with both being significantly enhanced compared with the controls. High levels of TNF and interleukin 1 correlated with depressed cardiovascular performance in the early phase of the shock. Our results confirm the important role of TNF and interleukin 1 as early mediators of septic shock. However, the benefit of reducing cytokine activity in later stages of septicemia seems to be dubious.

Clearance of vasoactive intestinal polypeptide (VIP) in the porcine pulmonary circulation.

The clearance of vasoactive intestinal polypeptide (VIP) in the lung was determined in pigs. To measure the first pass uptake, a bolus of VIP (0.9 pmol.kg-1 and 9 pmol.kg-1) with an inert intravascular marker, indocyanine green (ICG), was injected into the right atrium. The percent uptake of VIP after the higher bolus, as estimated by comparing the levels of VIP and ICG in the pulmonary artery and the aorta, was 36 +/- 6% during control infusion and 36 +/- 13% during continuous infusion of VIP (3 pmol.kg-1.min-1). The VIP concentrations in the pulmonary artery and the aorta were not different under baseline conditions, but during continuous VIP infusion the levels of plasma VIP in the pulmonary artery were higher than those in the aorta (24.3 +/- 1.6 pmol.l-1 and 20.4 +/- 1.3 pmol.l-1, resp. P less than 0.0001). These results indicate that the lung is not a source of plasma VIP, but the pulmonary circulation is a substantial contributor to the removal of VIP from plasma.