Patient-reported outcome measures obtained via E-Health tools ease the assessment burden and encourage patient participation in cancer care (PaCC Study).

Patient-reported outcome measures obtained via E-Health tools ease the assessment burden and encourage patient participation in cancer care (PaCC Study) BACKGROUND: E-health based patient-reported outcome measures (PROMs) have the potential to automate early identification of both nutrition status and distress status in cancer patients while facilitating treatment and encouraging patient participation. This cross-sectional study assessed the acceptability, accuracy, and clinical utility of PROMs collected via E-Health tools among patients undergoing treatment for stomach, colorectal, and pancreatic tumors. RESULTS: Eight-nine percent mostly, or completely, agreed that PROMs via tablets should be integrated in routine clinical care. Men were significantly more likely to require help completing the questionnaires than women (inv.OR= 0.51, 95% CI=(0.27, 0.95), p = 0.035). The level of help needed increased by 3% with each 1-year increase in age (inv. OR=1.03, 95% CI=(1.01, 1.06), p = 0.013). On average, a patient tended to declare weight which was 0.84 kg inferior to their true weight (Bland and Altman 95 % CI=(-3.9, 5.6); SD: 2.41) and a height which was 0.95 cm superior to their true height (Bland and Altman 95 % CI=(-5, 3.1); SD 2.08). Patient-reported nutrition status was significantly associated with the professionally generated assessment (95% CI=(2.27, 4.15), p < 0.001). As nutrition status declined, the distress score increased (95%CI=(0.88, 1.68), p < 0.001). Of the patients, 48.8% who were both distressed and malnourished requested supportive care to address their problems. CONCLUSION: Patient-reported assessments utilizing E-health tools are an accurate and efficient method to encourage patient participation in cancer care while simultaneously ensuring that regular assessment of psycho-social and nutritional aspects of care are efficiently integrated in the daily clinical routine.

Clinical Trial Results Summary for Laypersons: A User Testing Study.

OBJECTIVE: To apply "user testing" to maximize readability and acceptability of a Clinical Trial Results Laypersons Summary-a new European requirement. METHODS: "User testing" (using questionnaire and semistructured interview) assessed whether people could find and understand key points. Findings were used to improve content and design, prior to retesting. Participants had a range of levels of health literacy and there was a higher education group. Participants accessed the summary on screen. In round 1 we tested 12 points of information. In round 2 a revised summary addressing round 1 findings was tested, leading to a third final version. RESULTS: In round 1, 2 of 12 points of information did not reach the target and interviews raised further format and content issues (some distracting technical explanations and inability to find or understand the 2 main study purposes). These findings informed revisions for the version tested in round 2, with 2 different points not reaching the target (inclusion criteria relating to duration of seasonal allergies and how researchers found out about participants' symptoms). Identified problems in both rounds were addressed and reflected in the final version. Despite improvements, participants did not consistently understand that summaries were intended for the public, or to only interpret results of single trials in the context of additional trials. All readers, including those with higher education, found the clear and straightforward language acceptable. CONCLUSIONS: Applying "user testing" resulted in a largely health-literate summary suitable for people across a range of backgrounds.

[Differential diagnosis of dissociative seizures]. / Differenzialdiagnose dissoziativer Anfälle.

Patient history taking and semiology provide seminal clues to the diagnosis of dissociative seizures. Openness and alertness of the treating physician are essential. Video-electroencephalogram(EEG)-based analyses of the events are crucial to establish the correct diagnosis, particularly in complex cases. The patient-doctor relationship is of particular importance in order to successfully motivate the patient for psychotherapeutic treatment. Coexisting psychiatric morbidity as well as other functional somatic symptoms must be actively explored. Current changes in the established diagnostic manuals, including ICD-11, reflect the ongoing vivid interest and controversial discussions in the field of dissociative disorders.

New automated indirect immunofluorescent antinuclear antibody testing compares well with established manual immunofluorescent screening and titration for antinuclear antibody on HEp-2 cells.

The IIF using the HEp-2 cell substrate should be still considered the "gold standard" techniques for determination of antinuclear antibody (ANA). Standardization and automation can be considered to be still in progress. Aim of this study was to evaluate the performance of the commercially automated indirect immunofluorescent antinuclear HEp-2 antibody assay. The study was designed to compare two commercially available HEp-2 ANA by indirect immunofluorescent antibody assays using a sensitivity panel (120 clinically determined patients) and a specificity panel consisting of 78 clinically confirmed negative patients. We compared the NOVA View® system [INOVA Diagnostics San Diego, USA] with the new HELIOS Processor from AESKU Systems/AESKU.Diagnostics (Wendelsheim, Germany) to assess their capability for screening, pattern recognition and titration of the samples. These automated methods were directly compared to manual reading of the same processed slides on respective microscopes and also compared with the known clinical information. The results of the two automated methods were in very good agreement with recognizing negative and positive samples. The HELIOS system detected 188 samples correctly as negative or positive versus 187 detected by the NOVA View® system. The diagnostic sensitivity of the systems was 95.8 versus 96.7 % for HELIOS and NOVA View®, respectively. The systems exhibited a diagnostic specificity of 93.5 % for the HELIOS system and 91.0 % for the NOVA View®. Both systems are suitable for fast and reliable detection of positivity/negativity due to their high sensitivity and will lead to a further increase of standardization in autoimmunity.

Short-term outcomes of a novel endoscopic clipping device for closure of the internal opening in 100 anorectal fistulas.

BACKGROUND: One hundred consecutive applications of a new clipping device, the OTSC® Proctology (Ovesco Endoscopy AG), were analyzed to assess its efficacy for the treatment of complex anorectal fistulas. METHODS: In patients with anorectal fistulas, minimally invasive surgery with the OTSC® Proctology system was performed according to a standardized technique: the fistula tract was debrided using a special fistula brush, and the clip was applied on the internal fistula opening. In some of the patients, postoperative pain was evaluated using a visual analog scale. After 6 months, the postoperative clinical course and the fistula healing were assessed. RESULTS: A total of 100 OTSC® Proctology procedures were performed in 96 patients with 55 transsphincteric, 38 suprasphincteric, 2 extrasphincteric, and 5 rectovaginal fistulas. In all but 11 fistulas (8 Crohn's disease, 3 ulcerative colitis), the fistulas were of cryptoglandular origin. The median operation time was 32 min (range 17-66 min). There were no major intraoperative technical problems. All patients found the postoperative pain to be tolerable with standard pain medication. The short-term results of 99 clip applications were analyzed: the healing rate for first-line fistula therapy was 79 %, whereas in recurrent fistulas, the success rate was 26 %. OTSC® Proctology was successful in 45 % of fistulas associated with inflammatory bowel disease and in 20 % of rectovaginal fistulas. CONCLUSIONS: OTSC® Proctology provides convincing results as first-line treatment for complex cryptoglandular fistulas. It is a safe, effective, minimally invasive, and sphincter-sparing procedure with postoperative pain comparable to other types of fistula surgery.

Results of the Gore Bio-A fistula plug implantation in the treatment of anal fistula: a multicentre study.

BACKGROUND: The aim of this prospective study was to determine the efficiency of the Gore Bio-A synthetic plug in the treatment of anal fistulas. METHODS: A synthetic bioabsorbable anal fistula plug was implanted in 60 patients. All fistulas were transsphincteric and cryptoglandular in origin. RESULTS: The healing rate after 1 year of follow-up was 52 % (31 out of 60 patients). No patient was lost to follow-up. The treatment had no effect on the incontinence score. The plug dislodgement rate was 10 % (6 out of 60 patients). Thirty-four per cent of the patients (16 out of 47) required reoperation. The average operating time was 32 ± 10.2 min, and the average length of hospital stay was 3.3 ± 1.8 days. CONCLUSIONS: Synthetic plugs may be an alternative to bioprosthetic fistula plugs in the treatment of transsphincteric anal fistulas. This method might have better success rates than treatment with bioprosthetic fistula plugs.

Combined approach in the treatment of chronic anal fissures.

This study was designed to evaluate the healing and complications rates in surgically and conservatively treated patients with chronic anal fissure. Conservative treatment consisted of nitrate or diltiazem ointment. In case of surgery, fissurectomy was performed. In total, 340 patients were included in the study. Among them, 162 patients had surgery and 178 patients had conservative treatment. The healing rate at surgically treated group of patients varied between 95 and 98% depending on previous treatment. Group treated with nitrate ointment and group treated with diltiazem ointment showed, respectively 62% and 52% healing rates. Difference between ointments was not statistically significant. Average healing time was between 105 and 123 days and complication rates were between 1.7 and 5.4%. The surgical treatment showed much higher healing rates and thus should recommended as primary treatment option for the chronic anal fissure, especially if there are chronic secondary lesions already present. In case of conservative treatment, either nitrate or diltiazem ointment could be used with similar efficacy.

[Ways to psychosomatic rehabilitation--differential treatment selection between psychosomatic acute care and rehabilitation]. / Wege in die psychosomatische Rehabilitation--differenzielle Indikationsstellung an der Schnittstelle zwischen Krankenhaus und psychosomatischer Rehabilitationsklinik.

Consecutive admissions to the psychosomatic departments of 5 hospital units in southwest Germany registered between October 2012 and October 2013 were asked to participate in a study investigating the treatment selection process for psychosomatic rehabilitation. 527 patients were included in the study, 269 outpatients and 258 inpatients at the end of their inpatient treatment. 52 patients (10.1%) received the recommendation for rehabilitation. 47 (90.4%) could be followed up 3 months later. 22 patients had applied for a rehabilitation treatment, 11 (50%) had obtained an approval for their rehabilitation, 5 had still no answer and for 6 patients the request was refused. 4 of the latter had objected their refusal and were still waiting for an answer. Only one patient was already admitted to a rehabilitation center. Possible reasons for the low permeability at the interface between hospital care and rehabilitation are discussed.

Prospective pilot study of anorectal fistula closure with the OTSC Proctology.

AIM: The OTSC Proctology is a surgical device for anorectal fistula closure. It consists of a super-elastic nitinol clip, which is placed (with the aid of a transanal applicator) on the internal fistula opening to achieve healing of the fistula track. A prospective, two-centre clinical pilot study was undertaken to assess the efficacy and safety of the OTSC Proctology in patients with a complex high anorectal fistula. METHOD: In patients with a complex anorectal fistula the primary track was debrided using a special brush and the clip was applied to the internal fistula opening. After 6 months the postoperative clinical course and fistula healing were assessed. RESULTS: Twenty patients with a cryptoglandular anorectal fistula (14 with a transsphincteric fistula and six with a suprasphincteric fistula) were included in the study. There were no intra-operative technical or surgical complications. Postoperatively no patient reported intolerable discomfort or a sensation of a foreign body in the anal region. At 6 months after surgery, 18 (90%) patients had no clinical signs or symptoms of fistula and were considered healed, whereas in two the fistula persisted. In 13 (72%) of these 18 patients, the clip was still in place without causing problems, whereas in three patients the clip had spontaneously detached. In the two remaining patients it was necessary to remove the clip due to discomfort and delayed wound healing. CONCLUSION: Anorectal fistula closure with the OTSC Proctology is an innovative, sphincter-preserving minimally invasive procedure with promising initial results and a high rate of patient satisfaction.

[Operations for hemorrhoids: indications and techniques]. / Operationen beim Hämorrhoidalleiden: Indikation und Technik.

Haemorrhoidal disease is one of the most common diseases in general and will in most cases progress without therapy. In the therapeutic context the means of choice are conservative therapies and in the advanced stage of the disease operative measures are necessary. In Germany 40,000-50,000 operations are performed each year. Our aim with the currently available various operation techniques is individualized therapy and indications. Thus a high healing rate, low complication rate and high patient satisfaction can be achieved.

Gore BioA Fistula Plug in the treatment of high anal fistulas--initial results from a German multicenter-study.

BACKGROUND: Treatment of high anal fistulas may be associated with a high risk of continence disorders. Beside traditional procedure of flap-reconstruction the occlusion of the fistula tract using fistula-plugs offers a new sphincter-saving treatment option. In this study for the first time results from Germany are described. PATIENTS AND METHOD: 40 patients (30 male, 10 female, age 51 ± 12 years) underwent closure of a high trans-sphincteric (n = 28) or supra-sphincteric (n = 12) fistula with Gore BioA Fistula Plug(®) in three surgical departments. The surgical procedures had been performed by five colorectal surgeons. Four patients had Crohn's disease. Preoperatively 33 patients were completely continent; seven patients complained of minor continence disorders. Treatment of the patients was performed on a intent-to-treat basis and evaluation of the results was retrospective using pooled data from each center. RESULTS: Postoperatively one patient developed an abscess, which had to be managed surgically. In two patients the plug had fallen out within the first two weeks postoperatively. Six months after surgery the fistula has been healed in 20 patients (50.0%). Three additional fistulas healed after 7, 9 rsp. 12 months. The overall healing-rate was 57.5% (23/40). The healing rate differs considerably between the surgeons from 0 to 75% and depends on the number of previous interventions. In patients having only drainage of the abscess success occurred in 63.6% (14/22) whereas in patients after one or more flap fistula reconstruction the healing rate decreased slightly to 50% (9/18). No patient complained about any impairment of his preoperative continence status. CONCLUSION: By occlusion of high anal fistulas with a plug technique definitive healing could be achieved in nearly every second patients. Previous surgery seems to have a negative impact on success rate. We have not observed any negative impact on anal continence. From that point of view anal fistula plugs might be discussed as a treatment option for high anal fistulas, but further studies are needed to gain conclusive evidence.

The anal fistula claw: the OTSC clip for anal fistula closure.

AIM: Surgical closure of high or complex anal fistulae is often a difficult challenge. A special Nitinol clip, the OTSC clip (Ovesco AG), was evaluated for fistula closure in a porcine model. METHOD: A total of 20 fistulae were created in 10 animals by seton insertion. Four weeks after fistula induction the setons were removed: one internal fistula opening per animal was left untreated as control whereas the other opening was closed by the OTSC clip using a specially developed transanal clip applicator. The safety and technical feasibility of the clip application were tested. Another 4 weeks later, fistulae were macroscopically assessed for closure. For histological examination, the anorectum including the fistula tract was excised en bloc. RESULTS: Four weeks after clip placement, all external and internal fistula openings were macroscopically closed. The clip application site presented with an increased scarring. Microscopically, 40% of residual tracts and a more intense chronic inflammation were seen in the untreated control fistulae. After clip placement, 10% of the fistulae persisted associated with a higher density of collagen fibres indicating a better fistula scarring and healing. No unexpected side-effects or complications caused by the clip were observed. CONCLUSION: Fistula closure using the OTSC clip represents a promising sphincter-preserving minimally invasive procedure. This study demonstrated the safety and feasibility of the 'anal fistula claw' for fistula closure. In spite of limitations of the porcine model the results justify clinical applications and further investigations.

Advanced high-performance liquid chromatography method for highly polar nitroaromatic compounds in ground water samples from ammunition waste sites.

An advanced HPLC-photodiode array detection method for the determination of 12 selected highly polar nitroaromatic compounds in ground water samples of ammunition waste sites has been developed and validated. After solid-phase extraction the limits of detection were in the range 0.1-0.5 microg/l. To prove the applicability of the method to other polar nitroaromatic compounds the retention time of another 32 polar compounds under the specified chromatographic conditions were determined and their UV spectra recorded. To review the method, interlaboratory comparisons were performed with a spiked and a real ground water sample.

Local excision of early rectal cancer: is transanal endoscopic microsurgery an alternative to radical surgery?

OBJECTIVE: Transanal endoscopic microsurgery (TEM) allows locally complete excision of rectal neoplasms and provides an alternative to conventional surgery for benign tumours. However, its role in the curative treatment of invasive carcinoma is controversial. This paper examines the results of TEM compared with radical surgery (RS) for T1 rectal cancer. METHODS: 51 patients with T1 rectal tumours treated by RS, or local excision by means of TEM were included. The following parameters were evaluated: operating time, blood loss, hospital stay and complications, as well as local recurrence rate and survival. RESULTS: 17 patients were treated by RS and 34 by TEM. Operative time, blood loss, and duration of hospitalization were significantly lower in the TEM group compared with the RS group. In the RS group there were 4 patients with complications which required an operative revision (23.5%), compared to 1 reintervention (2.9%) in the TEM group. Local recurrence was 5.88% (n = 2) in the TEM group compared with none after RS (p = 0.547). The overall survival and disease-free survival showed not significant statistical differences between both groups (p = 0.59; p = 1.000, resp.). CONCLUSIONS: Although local recurrence was only observed after local excision, patients treated with TEM showed no significant differences in terms of overall survival and disease-free survival compared with patients who underwent RS. Inasmuch as local excision represents a minimally invasive technique in terms of morbidity, mortality and functional outcome, TEM should be offered as a valid option for well selected patients with early rectal cancer.

Local excision of early rectal cancer: is transanal endoscopic microsurgery an alternative to radical surgery?

Objetivo: la cirugía transanal endoscópica (TEM) permite la resección completa de neoplasias de recto siendo una alternativa a la cirugía convencional para tumores benignos. Existe controversia sobre su papel en el tratamiento curativo del cáncer de recto. Esta publicación compara los resultados entre la resección radical (RS) y la exéresis local vía TEM del cáncer de recto en estadio precoz. Métodos: se evaluaron 51 pacientes con neoplasia de recto cuya infiltración se limitaba a la submucosa (T1) y que fueron tratados mediante RS o TEM. Se evaluaron los siguientes parámetros: tiempo quirúrgico, pérdidas sanguíneas, estancia hospitalaria y complicaciones así como recidiva local y supervivencia. Resultados: 17 pacientes fueron tratados mediante RS y 34 vía TEM. El tiempo quirúrgico, el posible sangrado y la estancia hospitalaria fueron significativamente menores en el grupo TEM. En el grupo RS, 4 pacientes presentaron complicaciones que obligaron a una revision quirúrgica (23,5%), comparado con sólo 1 reintervención (2,9%) en grupo TEM. La recidiva local sólo fue observada en dos pacientes (5,88%) del grupo TEM (p = 0,547). La supervivencia global y libre de enfermedad no mostró diferencias estadísticamente significativas entre ambos grupos (p = 0,59 y p = 1,000, respectivamente). Conclusiones: si bien el grupo tratado con TEM advirtió dos recidivas locales, no se observaron diferencias en términos de supervivencia global y libre de enfermedad entre los dos grupos analizados. En tanto la resección local representa una técnica mínimamente invasiva en términos de morbilidad, mortalidad y resultados funcionales, la exéresis mediante TEM debe ser ofertada como una opción válida para pacientes muy bien seleccionados con carcinoma de recto en estadio precoz(AU)

Objective: transanal endoscopic microsurgery (TEM) allows locally complete excision of rectal neoplasms and provides an alternative to conventional surgery for benign tumours. However, its role in the curative treatment of invasive carcinoma is controversial. This paper examines the results of TEM compared with radical surgery (RS) for T1 rectal cancer. Methods: 51 patients with T1 rectal tumours treated by RS, or local excision by means of TEM were included. The following parameters were evaluated: operating time, blood loss, hospital stay and complications, as well as local recurrence rate and survival. Results: 17 patients were treated by RS and 34 by TEM. Operative time, blood loss, and duration of hospitalization were significantly lower in the TEM group compared with the RS group. In the RS group there were 4 patients with complications which required an operative revision (23.5%), compared to 1 reintervention (2.9%) in the TEM group. Local recurrence was 5.88% (n = 2) in the TEM group compared with none after RS (p = 0.547). The overall survival and disease-free survival showed not significant statistical differences between both groups (p = 0.59; p = 1.000, resp.). Conclusions: although local recurrence was only observed after local excision, patients treated with TEM showed no significant differences in terms of overall survival and disease-free survival compared with patients who underwent RS. Inasmuch as local excision represents a minimally invasive technique in terms of morbidity, mortality and functional outcome, TEM should be offered as a valid option for well selected patients with early rectal cancer(AU)

Enteral vs parenteral nutrition in reconstructive anal surgery--a prospective-randomized trial.

OBJECTIVE: Early defecation after reconstructive anal surgery may influence the outcome negatively. Different methods are used to avoid bowel movements in the early postoperative period. We questioned whether stool behaviour is influenced by total parenteral nutrition as opposed to enteral nutrition with resorbable sip feeds. Furthermore, satisfaction of patients with each nutrition regime, cost differences and influence of the postoperative outcome were evaluated. METHOD: Between January and October 2004, 32 patients were evaluated in a prospective randomized, surgeon-blinded trial. The parenteral group (PG, n = 16) received 1250 ml Nutriflex lipid basal (B. Braun Comp., Melsungen, Germany) intravenously. The enteral group (EG, n = 16) was offered a total amount of three cups of Clinutren fruit (Nestle Nutrition GmbH, Frankfurt, Germany), two boxes of OPD (oligopeptide diet) Elemental 028 extra (SHS, Liverpool, UK) and two cups of OPD Peptamen (Nestle Nutrition GmbH). Both groups received 1000 ml of isotonic cristalloid solution and were allowed to drink up to 1000 ml of tea or water per 24 h. RESULTS: The satisfaction of patients was significantly higher in the EG. In regard to stool behaviour both groups showed no differences, in the number of bowel movements or in the time to the first postoperative defecation. Enteral feeding resulted in a minimum saving of 220 euros. Postoperative results in the case of plastic fistula closure did not differ between both groups. CONCLUSIONS: Sufficient bowel confinement during the early postoperative period after anal reconstructive surgery may be achieved by using resorbable sip feeds rather than parenteral nutrition.

[Rare complication after STARR operation]. / Seltene Komplikation nach STARR-Operation.

Longo's STARR operation is a new surgical technique for the management of obstructive defecation syndrome. A major advantage is the repair of rectocele and intussusception in a single transanal approach. Complications such as bleeding, infection, anal stenosis, and fistulas are known. In the described patient we detected a cavity in the spatium rectovaginale which was lined by rectum mucosa and connected to the rectum as a result of an incomplete resection of rectum wall and dilatation of the stapler suture. Recurrent stool incrustration in the cavity led to preformation of coproliths. We performed a modified Rehn-Delorme operation to resect the cavity. The STARR operation is a technique which should be used carefully and performed only by surgeons with experience and full knowledge of the potential complications.

Retrorectal tumors: excision by transanal endoscopic microsurgery.

Tumours within the retrorectal space are uncommon. Due to their rarity and diverse symptoms they are often misdiagnosed or mistreated. We report three cases of women presenting a variety of symptoms including increased rectal pain, recurrent abscesses/fistulas and constipation. Upon clinical examination and further investigations using MR scan, endorectal ultrasound and endoscopy, a retrorectal mass was suspected in all three cases. In order to achieve a complete excision of the tumor while minimizing trauma, transanal endoscopic microsurgery (TEM) was performed. The histology of the multicystic tumor revealed in all three cases a tailgut cyst. As far as we know this is the first report describing the use of TEM for surgical treatment of tumors located in the retrorectal space.