Prospective and multicentre study of radiofrequency treatment in anal fistula.

BACKGROUND: The most effective treatment for anal fistula is fistulotomy, but it involves a risk of anal incontinence. To reduce this morbidity, sphincter-sparing treatments have been developed, but their success in real life is often less than 50%. The aim is to determine the clinical healing rate 6 months after radiofrequency treatment. METHODS: We planned to evaluate 50 patients from three French proctology centres. Treatment efficacy was evaluated at 6 and 12 months by means of clinical and magnetic resonance imaging examination. We evaluated morbidity and healing prognostic factors. RESULTS: Fifty patients with a mean age of 51 years (22-82) were included. Eleven patients had a low trans-sphincteric fistula (LTS), 21 patients had a high trans-sphincteric fistula (HTS), eight had a complex fistula and nine had Crohn's disease fistula. After 6 months, 17 patients (34.7%) had a clinically healed fistula, including five (45.5%) with LTS fistula, seven (33.3%) with HTS fistula, one (12.5%) with complex fistula, four (44.4%) with Crohn's disease, with no significant difference between these fistula types (p: 0.142). At 12 months, the healing rate was identical. MRI in 15 out of 17 clinically healed patients showed a deep remission of 73.3% at 12 months. Energy power was associated with the success of the treatment. There was an 8.2% incidence of post-surgical complications with 4.1% being abscesses (one required surgical management). Postoperative pain was minor. No new cases or deterioration of continence have been shown. CONCLUSION: Radiofrequency is effective in 34.7% of the cases as an anal fistula treatment in this first prospective study, with low morbidity and no effect on continence. Clinical healing was deep (MRI) in three-quarters at 1 year. The increase in energy power during the procedure seems to be a key point to be analysed to optimise results.

Surgical closure, mainly with glue injection and anti-tumour necrosis factor α, in fistulizing perianal Crohn's disease: A multicentre randomized controlled trial.

AIM: In patients with fistulizing perianal Crohn's disease (CD), the need for a secondary surgical step is not defined. The aim was to assess the efficacy of surgical closure compared to a single seton removal in patients with drained fistulizing perianal CD treated with adalimumab. METHODS: This was a multicentre, randomized controlled trial, comparing seton removal + surgical closure (closure group) to seton removal alone (control group) with a stratification according to the American Gastroenterological Association classification. The primary end-point was fistula closure at month 12 defined by the association of the following criteria: no seton, absence of a visible external opening, absence of discharge from the tract after finger compression, absence of an internal opening, absence of perianal pain/abscess and absence of fistula-related abnormalities. RESULTS: Among the 64 included patients (262 expected) (48 complex fistula, 75%), 33 were randomized to the closure group and 31 to the control group. In the closure group, 26 patients (78.8%) had glue. At month 12, overall fistula closure was achieved in 35 of the evaluable 58 patients (60%): 18/32 (56%) in the surgery group and 17/26 (65%) in the control group (P = 0.479). In the closure group, fistula closure was observed in 13/25 (52%) and 5/7 (71%) patients with complex and simple fistula respectively (P = 0.426), compared with 12/18 (67%) and 5/8 (63%), respectively in the control group (P = 1.000). CONCLUSIONS: Seton removal alone seems to be no more effective than a secondary surgical step (in particular glue injection) in patients having fistulizing perianal CD controlled by an initial drainage combined with adalimumab. The results should be interpreted with caution.

Real-life golimumab persitence in patients with axial spondyloarthritis: post-hoc results of the prospective observational cohort study, GO-PRACTICE.

OBJECTIVES: To evaluate in clinical practice the persistence and safety of golimumab, together with the evolution of disease activity and patient reported outcomes, in adult patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis (axSpA). This article focuses on the outcomes of golimumab treatment in axSpA patients. METHODS: Golimumab persistence 24 months after initial prescription (primary outcome) was assessed using Kaplan-Meier estimates. Secondary outcomes included evaluations of disease activity evolution (ASDAS and BASDAI), patient-reported outcomes (EQ-5D, SF-12 and HAQ), and golimumab's safety profile. RESULTS: Of 478 axSpA patients, 60.9% were biologic-naïve. Mean age and proportion of females were higher in biologics-pretreated patients (46.8 vs. 40.2 years, p<0.001 and 62.0% vs. 49.8%, p=0.009, respectively). Golimumab persistence at 24 months was 52.6% [95% CI 47.9-57.1%] in the axSpA cohort. It was 59.2% [95% CI 53.1-64.8%] and 42.7% [95% CI 35.3-49.8%] respectively, for biologics-naïve and biologics-pretreated patients (p<0.01), and 65.9% [95% CI 58.9-72.0%] and 41.5% [95% CI 35.2-47.6%], respectively for males and females (p<0.01). Reasons for golimumab discontinuation were primary non-response (37.4%), secondary non-response (24.8%) and intolerance (21.5%). Disease activity and patient reported outcomes improved significantly for those who persisted at 24 months and were higher for biologics-naïve patients. CONCLUSIONS: Golimumab persistence at 2 years in axSpA patients was 52.6%. Previous treatment with another biologic and female gender were associated with earlier discontinuation. Golimumab was a well-tolerated therapy for axSpA, with no new safety signals observed.

Socio-economic factors & longevity in a cohort of Kerala State, India.

BACKGROUND & OBJECTIVES: Even though Kerala State is well-known for its egalitarian policies in terms of healthcare, redistributive actions and social reforms, and its health indicators close to those of high-resource countries despite a poor per-capita income, it is not clear whether socio-economic disparities in terms of life expectancy are observed. This study was therefore carried out to study the impact of socio-economic level on life expectancy in individuals living in Kerala. METHODS: A cohort of 1,67,331 participants aged 34 years and above in Thiruvananthapuram district, having completed a lifestyle questionnaire at baseline in 1995, was followed up for mortality and cause of death until 2005. Survival estimates were based on the participants' vital status and death rates were calculated separately for men and women and for several socio-economic factors, stratified by age. RESULTS: At 40 years, men and women were expected to live another 34 and 37 years, respectively. Life expectancy varied across the participants' different socio-economic categories: those from high income households with good housing conditions, materially privileged households and small households, had a 2-3 years longer life expectancy as compared to the deprived persons. Also, those who went to college lived longer than the illiterates. The gaps between categories were wider in men than in women. INTERPRETATION & CONCLUSIONS: Socio-economic disparity in longevity was observed: wealthy people from Kerala State presented a longer life expectancy.

Accuracy of visual inspection with acetic acid for cervical cancer screening.

OBJECTIVE: To provide an updated estimation of the accuracy of visual inspection with acetic acid (VIA) in detecting true disease. METHODS: A PubMed search provided original studies on VIA accuracy in which the gold standard for confirmatory testing was histology alone or colposcopy followed by biopsy. The numbers of true-positive, false-positive, false-negative, and true-negative results were extracted from each study. Meta-analyses were then performed with different categories of studies according to confirmatory diagnosis threshold, category of women who received confirmatory testing, and whether a medical condition that could affect VIA accuracy was present at screening. The reference category consisted of 26 studies in which VIA was performed on asymptomatic women who all underwent confirmatory testing and in which the disease threshold was cervical intraepithelial neoplasia grade 2. RESULTS: We report an 80% sensitivity (range, 79%-82%) and a 92% specificity (range, 91%-92%) for VIA. Study region, capacity of screener, or size of the study population did not modify VIA accuracy. The positive predictive value was 10% (range, 9%-10%). CONCLUSION: Screening for precancerous and cancerous cervical lesions using VIA is a simple, low-cost, and efficient alternative to cytologic testing in low-resource areas.

Effect of tobacco chewing, tobacco smoking and alcohol on all-cause and cancer mortality: a cohort study from Trivandrum, India.

OBJECTIVE: To study the risk of all-cause, cancer and tobacco-related cancer mortality associated with tobacco chewing, tobacco smoking and alcohol use. DESIGN: Prospective community-based cohort study initiated in 1996. PARTICIPANTS: 167343 adult subjects, aged 34 and older, living in 13 panchayaths (rural municipal administrative units) in South India, were regularly followed-up for a mean duration of 6.5 years. MAIN OUTCOME MEASURES: Mortality from all-causes, all cancer and tobacco-related cancer. RESULTS: The mortality risks associated with chewing (and 95% confidence intervals), after adjusting for age, sex, socio-economic and dietary variables, and for other habits, were 0.90 (0.86-0.94) for all-cause, 1.07 (0.94-1.22) for cancer and 1.22 (1.04-1.44) for tobacco-related cancer; with smoking the respective mortality risks were 1.31 (1.24-1.39), 1.63 (1.37-1.94) and 1.68 (1.36-2.08); and with alcohol use the risks were 1.13 (1.06-1.20), 1.32 (1.11-1.57) and 1.47 (1.19-1.80), respectively. Reduced risk of all-cause mortality by chewing was observed only in the 60-84 years old group (0.90 (0.85-0.94)), and detrimental effects of chewing on cancer mortality were shown in the young and middle-age groups: 34-39 years old (1.33 (0.67-2.65)), and 40-59 years old (1.26 (1.03-1.55)). CONCLUSION: Tobacco in any form and alcohol uses were harmful and a higher quality of life could be achieved by avoiding these habits. Given the demographic, epidemiological and economic transitions and changes in pattern of tobacco and alcohol use in India, the health loss from the tobacco and alcohol will grow even larger, unless effective interventions and policies to reduce these habits are implemented.

Alcohol intake and oral cavity cancer risk among men in a prospective study in Kerala, India.

OBJECTIVE: The aim of the study was to evaluate the role of alcohol drinking and patterns of consumption in oral cancer incidence and mortality in a cohort study using data from the Trivandrum Oral Cancer Screening Study, India. METHODS: At baseline, the study participants completed a lifestyle questionnaire including items on frequency and duration of alcohol consumption. They were followed up for oral cancer incidence and mortality. Data from 32 347 subjects, of whom 134 eventually developed oral cancer, were analysed to estimate risk of oral cancer incidence and mortality according to drinking patterns, using a Cox regression model adjusted for age, religion, education, occupation, body mass index (BMI), standard of living index, chewing habits, smoking habits, and vegetable and fruit intake. RESULTS: Current and past drinkers were each associated with significantly increased risk of developing oral cancer. The hazard ratio increased significantly by 49% (95% CI = 1-121%) among current drinkers and 90% (95% CI = 13-218%) among past drinkers. A significant dose-response relationship between intake frequency, duration and oral cancer risk (incidence and mortality) was observed. CONCLUSIONS: As with other lifestyle factors, alcohol intake plays an important role in oral carcinogenesis in this population, and understanding this role is relevant to developing public health policies targeting at-risk population.

Effectiveness and safety of loop electrosurgical excision procedure for cervical neoplasia in rural India.

OBJECTIVE: To evaluate the effectiveness and safety of loop electrosurgical excision procedure (LEEP) to treat cervical intraepithelial neoplasia (CIN) in rural India. METHOD: Women with CIN colposcopic features unsuitable for cryotherapy were treated with LEEP using a "see-and-treat" approach. Women with unsatisfactory colposcopy had diagnostic LEEP. Cure was defined as no clinical or histologic evidence of CIN at 1-year follow-up. Factors influencing cure rates were evaluated by chi(2) tests. RESULTS: Of the 1,141 women who underwent LEEP (569 see-and-treat; 572 unsatisfactory colposcopy), 634 had histologically proven CIN. Of those, 489 reported for follow-up and 459 (93.9%) had no evidence of disease. Cure rates were 98.1% for women with CIN 1, 93.6% for CIN 2, and 85.0% for CIN 3. Patients with CIN 2-3 had significantly lower cure rates. CONCLUSION: Cure rates for LEEP provided by newly trained doctors in rural India were similar to those reported in the gynecological literature.

Effectiveness and safety of loop electrosurgical excision procedure in a low-resource setting.

OBJECTIVE: To evaluate the effectiveness and safety of the loop electrosurgical excision procedure (LEEP) to treat cervical intraepithelial neoplasia (CIN) in a low-resource setting. METHODS: Women participating in a cervical screening study in India with histologically confirmed CIN unsuitable for cryotherapy were advised to undergo LEEP. One year after treatment the cervix was visually inspected with acetic acid, followed by colposcopy and biopsy taken from abnormal areas. Cure was defined as no clinical or histologic evidence of CIN. Factors influencing cure rates were evaluated by chi(2) tests. RESULTS: Of the 311 women who underwent LEEP, 283 reported for 1-year follow-up and 248 (87.6%) were disease free. Cure rates were 93.0% for CIN 1, 85.5% for CIN 2, and 72.7% for CIN 3. Minor adverse effects were observed in 34 women and complications were seen in 5 women. CONCLUSION: LEEP was associated with minimal complications and acceptable cure rates in a low-resource setting, although women with larger lesions had lower cure rates.

Effectiveness, safety, and acceptability of cryotherapy by midwives for cervical intraepithelial neoplasia in Maharashtra, India.

OBJECTIVE: To evaluate the effectiveness, safety, and acceptability of cryotherapy for cervical intraepithelial neoplasia (CIN) when provided by trained midwives in rural India. METHOD: Women with colposcopic findings of CIN lesions suitable for ablative treatment received cryotherapy from trained midwives before the biopsy results were known. Cure rates, adverse effects, and complications were assessed and factors influencing cure rates were evaluated by chi(2) tests. Cure was defined as no clinical or histologic evidence of CIN lesions 6 or more months after treatment. RESULTS: Of 1068 women treated with cryotherapy, 728 had histologically proven CIN in their pretreatment biopsy specimens; of the 574 reporting for follow-up, 538 (93.7%) were cured (95% confidence interval [CI], 92.1%-96.3%). Cure rates were 96.4% (95% CI, 94.6%-98.1%) for CIN 1 and 82.1% (95% CI, 74.7%-89.4%) for CIN 2 and CIN 3 lesions combined. Minor adverse effects were documented in 5.2% of the women. CONCLUSION: Cryotherapy provided by midwives was found to be safe, effective, and acceptable by the women.

Effect of visual screening on cervical cancer incidence and mortality in Tamil Nadu, India: a cluster-randomised trial.

BACKGROUND: Cervical cancer is the most common cancer among women in developing countries. We assessed the effect of screening using visual inspection with 4% acetic acid (VIA) on cervical cancer incidence and mortality in a cluster randomised controlled trial in India. METHODS: Of the 114 study clusters in Dindigul district, India, 57 were randomised to one round of VIA by trained nurses, and 57 to a control group. Healthy women aged 30 to 59 years were eligible for the study. Screen-positive women had colposcopy, directed biopsies, and, where appropriate, cryotherapy by nurses during the screening visit. Those with larger precancerous lesions or invasive cancers were referred for appropriate investigations and treatment. Cervical cancer incidence and mortality in the study groups were analysed and compared using Cox regression taking the cluster design into account, and analysis was by intention to treat. The primary outcome measures were cervical cancer incidence and mortality. RESULTS: Of the 49,311 eligible women in the intervention group, 31,343 (63.6%) were screened during 2000-03; 30,958 control women received the standard care. Of the 3088 (9.9%) screened positive, 3052 had colposcopy, and 2539 directed biopsy. Of the 1874 women with precancerous lesions in the intervention group, 72% received treatment. In the intervention group, 274,430 person years, 167 cervical cancer cases, and 83 cervical cancer deaths were accrued compared with 178,781 person-years, 158 cases, and 92 deaths and in the control group during 2000-06 (incidence hazard ratio 0.75 [95% CI 0.55-0.95] and mortality hazard ratio 0.65 [0.47-0.89]). INTERPRETATION: VIA screening, in the presence of good training and sustained quality assurance, is an effective method to prevent cervical cancer in developing countries.