STARR with CONTOUR® TRANSTAR™ device for obstructed defecation syndrome: one-year real-world outcomes of the European TRANSTAR registry.

PURPOSE: Stapled transanal rectal resection (STARR) in patients with obstructive defecation syndrome (ODS) is limited by the capacity of the circular stapler used. This prospective cohort study was conducted to assess real-world clinical outcomes of STARR with the new CONTOUR® TRANSTAR™ device, shortly named TRANSTAR, at 12 months postoperatively. METHODS: From January 2009 to January 2011, consecutive patients who underwent TRANSTAR in 22 European colorectal centers were enrolled in the study. Functional outcomes and quality of life were assessed by the changes in a number of scoring systems (Knowles-Eccersley-Scott-Symptom (KESS) score, ODS score, St. Mark's score, Euro Quality of Life-5 Dimension (EQ-5D) score, and Patient Assessment of Constipation-Quality of Life (PAC-QoL) score), at 12 months as compared to baseline. All complications were recorded and analyzed. RESULTS: A total of 100 patients (98% female), mean age 60 years, were entered in the study. Statistically significant improvements were seen in the KESS (median 18 vs. 6; p < 0.01), ODS (median 15 vs. 4; p < 0.01), and PAC-Qol scores (median 2.10 vs. 0.86; p < 0.01). St. Mark's and EQ-5D scores improved nonsignificantly. Complications were reported in 11 % of patients, including bleeding (5%), staple line complications (3%), urinary retention (2%), and persistent pain (1%). No major complications or mortality occurred. CONCLUSION: TRANSTAR facilitated a tailored, real circumferential full-thickness rectal resection, leading to improved patient functional and quality of life outcomes at 12 months postoperatively. It represents a safe and effective treatment for ODS in local clinical practice, although the sustainability of real-world results needs to be proven in the long-term follow-up.

Diabetes and weight in comparative studies of bariatric surgery vs conventional medical therapy: a systematic review and meta-analysis.

We performed a meta-analysis of weight loss and remission of type 2 diabetes mellitus (T2DM) evaluated in randomized controlled trials (RCTs) and observational studies of bariatric surgery vs conventional medical therapy. English articles published through June 10, 2013 that compared bariatric surgery with conventional therapy and included T2DM endpoints with ≥12-month follow-up were systematically reviewed. Body mass index (BMI, in kilogram per square meter), glycated hemoglobin (HbA1C, in degree), and fasting plasma glucose (FPG, in milligram per deciliter) were analyzed by calculating weighted mean differences (WMDs) and pooled standardized mean differences and associated 95 % confidence intervals (95 % CI). Aggregated T2DM remission event data were analyzed by calculating the pooled odds ratio (POR) and 95 % CI. Random effects assumptions were applied throughout; I(2) ≥ 75.0 % was considered indicative of significant heterogeneity. Systematic review identified 512 articles: 47 duplicates were removed, 446 failed inclusion criteria (i.e., n < 10 per arm, animal studies, reviews, case reports, abstracts, and kin studies). Of 19 eligible articles, two not focused on diagnosed T2DM and one with insufficient T2DM data were excluded. In the final 16 included papers, 3,076 patients (mean BMI, 40.9; age, 47.0; 72.0 % female) underwent bariatric surgery; 3,055 (39.4; 48.6, 69.0 %) received conventional or no weight-loss therapy. In bariatric surgery vs conventional therapy groups, the mean 17.3 ± 5.7 month BMI WMD was 8.3 (7.0, 9.6; p < 0.001; I(2) = 91.8), HbA(1C) was 1.1 (0.6, 1.6; p < 0.001; I(2) = 91.9), and FPG, 24.9 (15.9, 33.9; p < 0.001; I(2) = 84.8), with significant differences favoring surgery. The overall T2DM remission rate for surgery vs conventional group was 63.5 vs 15.6 % (p < 0.001). The Peto summary POR was 9.8 (6.1, 15.9); inverse variance summary POR was 15.8 (7.9, 31.4). Of the included studies, 94.0 % demonstrated a significant statistical advantage favoring surgery. In a meta-analysis of 16 studies (5 RCTs) with 6,131 patients and mean 17.3-month follow-up, bariatric surgery was significantly more effective than conventional medical therapy in achieving weight loss, HbA(1C) and FPG reduction, and diabetes remission. The odds of bariatric surgery patients reaching T2DM remission ranged from 9.8 to 15.8 times the odds of patients treated with conventional therapy.

3-year real-world outcomes with the Swedish adjustable gastric band™ in France.

The study objective was to ascertain outcomes with the Swedish adjustable gastric band (SAGB) on an intention-to-treat basis in multiple centers across the French social health insurance system. SAGB results at 3-year follow-up are reported. The noncomparative, observational, prospective, consecutive cohort study design sought a 500-patient minimum recruitment geographically representative of continental France. Safety (adverse events [AEs], device-related morbidity, and mortality) and effectiveness (change in body mass index [BMI, kilograms per square meter], percentage excess weight loss, comorbidities, quality of life [QoL]) were assessed. Adjustable gastric band survival was calculated. Thirty-one surgeons in 28 multidisciplinary teams/sites enrolled patients between September 2, 2007 and April 30, 2008. SAGB was successfully implanted in 517 patients: 88.0 % female; mean age, 37.5 years; obesity duration, 15.3 years (baseline: mean BMI, 41.0; comorbidities, 773 in 74.3 % of patients; Bariatric Analysis and Reporting Outcome System (BAROS), 1.4; EuroQoL 5-Dimensions (EQ-5D), 0.61; EuroQoL-visual analog scale (EQ-VAS), 52.3). At 3 years: BMI, 32.2 (mean change, -9.0; p < 0.0001); excess weight loss, 47.4 %; comorbidities, 161 in 27.2 %; BAROS, 3.6 (+2.2, p < 0.0001); EQ-5D, 0.84 (+0.22, p < 0.0001); EQ-VAS, 73.4 (+21.4, p < 0.0001). SAGB-induced weight loss was associated with substantially improved QoL. One death occurred and was unrelated to the treatment. No AE was reported in 68.3 % of patients, and no confirmed device-related AE in 77.0 %. Overall AE rate was 0.19 per patient year. Device retention was 87.0 %. Analysis of patients lost to follow-up showed a nonsignificant effect on overall study results. In a prospective, consecutive cohort, "real-world", nationwide study, the Swedish Adjustable Gastric Band was found safe and effective at 3-year follow-up.

Laparoscopic greater curvature plication (LGCP) for treatment of morbid obesity in a series of 244 patients.

BACKGROUND: Laparoscopic greater curvature plication (LGCP) is a new metabolic/bariatric surgical procedure that requires no resection, bypass, or implantable device. We report LGCP outcomes in 244 morbidly obese patients. METHODS: Between 2010 and 2011, patients underwent LGCP. Body mass index (BMI, kilogram per square meter) evolution, excess BMI loss (%EBMIL), excess weight loss (%EWL), complications, and type 2 diabetes mellitus (T2DM) changes were recorded. Repeated-measures analysis of variance (ANOVA) was used to assess weight change at 6, 12, and 18 months. Subgroup analyses were conducted to provide benchmark outcomes at 6 months. Logistic regression was used to identify characteristics predictive of suboptimal weight loss. RESULTS: Mean baseline BMI (±SD) was 41.4 ± 5.5 (80.7 % women, mean age 46.1 ± 11.0 years, 68 [27.9 %] patients had T2DM). Mean operative time was 70.6 min; mean hospitalization, 36 h (24-72). Sixty-eight patients (27.9 %) experienced postoperative nausea and/or vomiting that was controlled within 36 h. There was no mortality. Major complication rate was 1.2 % (n = 3). Repeated-measures ANOVA indicated significant weight loss across time points (p < 0.001). At 6 months (n = 105), BMI, %EBMIL, and %EWL were 36.1 ± 4.7, 34.8 ± 17.3, and 31.8 ± 15.9. Preoperative BMI was the only predictor of weight loss. Patients with BMI <40 lost more weight than those ≥40, although by 9 months, differences were no longer significant. In patients with preoperative BMI <40, 18-month %EWL approached 50 % and %EBMIL exceeded 50 %. At 6 months, 96.9 % of patients' T2DM was significantly improved/resolved. CONCLUSIONS: Over the short term, LGCP results in effective weight loss and significant T2DM reduction with a very low rate of complications.

Metabolic surgery for the treatment of type 2 diabetes in patients with BMI <35 kg/m2: an integrative review of early studies.

Type 2 diabetes mellitus (T2DM) resolution in morbidly obese patients following metabolic surgery suggests the efficacy of T2DM surgery in non-morbidly obese patients (body mass index [BMI] <35 kg/m(2)). This literature review examined research articles in English over the last 30 years (1979-2009) that addressed surgical resolution of T2DM in patients with a mean BMI <35. Weighted and simple means (95% CI) were calculated to analyze study outcomes. Sixteen studies met inclusion criteria; 343 patients underwent one of eight procedures with 6-216 months follow-up. Patients lost a clinically meaningful, not excessive, amount of weight (from BMI 29.4 to 24.2; -5.1), moving from the overweight into the normal weight category. There were 85.3% patients who were off T2DM medications with fasting plasma glucose approaching normal (105.2 mg/dL, -93.3), and normal glycated hemoglobin, 6% (-2.7). In subgroup comparison, BMI reduction and T2DM resolution were greatest following malabsorptive/restrictive procedures, and in the preoperatively mildly obese (30.0-35.0) vs overweight (25.0-25.9) BMI ranges. Complications were few with low operative mortality (0.29%). Novel and/or known mechanisms of T2DM resolution may be engaged by surgery at a BMI threshold

Stapled haemorrhoidopexy compared to Milligan-Morgan and Ferguson haemorrhoidectomy: a systematic review.

PURPOSE: The aim of this study was to perform a systematic review and meta-analysis of the short- and long-term outcomes of stapled haemorrhoidopexy. METHODS: A literature search identified randomised controlled trials comparing stapled haemorrhoidopexy with Milligan-Morgan/Ferguson haemorrhoidectomy. Data were extracted independently for each study and differences analysed with fixed and random effects models. RESULTS: Thirty-four randomised trials and two systematic reviews were identified, and 29 trials included. Stapled haemorrhoidopexy was statistically superior for hospital stay (p < 0.001) and numerically superior for post-operative pain (peri-operative and mid-term), operation time and bleeding (post-operative and long-term). Recurrent prolapse and re-intervention for recurrence were more frequent following stapled haemorrhoidopexy. No difference was observed in the rates of complications. CONCLUSIONS: Stapled haemorrhoidopexy reduces the length of hospital stay and may have an advantage in terms of decreased operating time, reduced post-operative pain and less bleeding but is associated with an increased rate of recurrent prolapse.

[Knee flexion after rotational knee endoprosthesis]. / Knieflexion nach Rotationsknieendoprothese.

UNLABELLED: In the presented study the question was evaluated if--after rotational knee arthroplasty--range of motion must be restored at discharge or if range of motion can also be restored with delay during the first postoperative year. METHOD: A retrospective study was performed on 45 patients. These had been rehabilitated with a specific therapeutical concept which did not include early restoration at discharge of complete range of motion as the key principle. RESULTS: The mean range of motion was 60 degrees +/- 21 degrees at discharge. At the date of presentation 12 to 18 months postoperatively the mean range of motion had improved to 110 degrees +/- 19 degrees. CONCLUSIONS: The presented study indicates that complete restoration of range of motion after rotational knee arthroplasty may not necessarily be restored at discharge.

[Preliminary clinical study of the use of itraconazole in the treatment of vulvovaginal candidiasis]. / Studio clinico preliminare sull'impiego dell'itraconazolo nel trattamento della vulvovaginite da candida.

Thirty women (28 of childbearing age and 2 in the menopause), affected by acute Candida albicans vulvovaginitis were treated orally with a new antimycotic triazole derivative, itraconazole. Twenty patients were administered with 200 mg/die of itraconazole for three days. In tests carried out 7 and 30 days after the end of therapy the following results were observed. Negative cultures in 95% of patients and in 75% of patients; absence of leukorrhea in 60% of patients and in 65% of patients; disappearance of pruritus in 95% of patients and in 80% of patients. Ten patients were administered with an acute dose of itraconazole (400 mg). In the same tests, carried out 7 and 30 days after the end of therapy reported above the results were as follow. Negative culture in 80% and 60% of patients; absence of leukorrhea in 50% and 60% of patients; absence of pruritus in 70% and 50% of patients. In the first group of patients one case of slight nausea was reported whilst in the second group there were two cases of nausea, one of gastralgia and one of urticaria. No systemic side-effect was seen.