Background
A single flexible sigmoidoscopy at around the age of 60 years has been proposed as an effective strategy for colorectal cancer (CRC) screening.
Methods
We conducted a randomized controlled ...trial to evaluate the effect of flexible sigmoidoscopy screening on CRC incidence and mortality. A questionnaire to assess the eligibility and interest in screening was mailed to 236 568 men and women, aged 55-64 years, who were randomly selected from six trial centers in Italy. Of the 56 532 respondents, interested and eligible subjects were randomly assigned to the intervention group (invitation for flexible sigmoidoscopy; n = 17 148) or the control group (no further contact; n = 17 144), between June 14, 1995, and May 10, 1999. Flexible sigmoidoscopy was performed on 9911 subjects. Intention-to-treat and per-protocol analyses were performed to compare the CRC incidence and mortality rates in the intervention and control groups. Per-protocol analysis was adjusted for noncompliance.
Results
A total of 34 272 subjects (17 136 in each group) were included in the follow-up analysis. The median follow-up period was 10.5 years for incidence and 11.4 years for mortality; 251 subjects were diagnosed with CRC in the intervention group and 306 in the control group. Overall incidence rates in the intervention and control groups were 144.11 and 176.43, respectively, per 100 000 person-years. CRC-related death was noted in 65 subjects in the intervention group and 83 subjects in the control group. Mortality rates in the intervention and control groups were 34.66 and 44.45, respectively, per 100 000 person-years. In the intention-to-treat analysis, the rate of CRC incidence was statistically significantly reduced in the intervention group by 18% (rate ratio RR = 0.82, 95% confidence interval CI = 0.69 to 0.96), and the mortality rate was non-statistically significantly reduced by 22% (RR = 0.78; 95% CI = 0.56 to 1.08) compared with the control group. In the per-protocol analysis, both CRC incidence and mortality rates were statistically significantly reduced among the screened subjects; CRC incidence was reduced by 31% (RR = 0.69; 95% CI = 0.56 to 0.86) and mortality was reduced by 38% (RR = 0.62; 95% CI = 0.40 to 0.96) compared with the control group.
Conclusion
A single flexible sigmoidoscopy screening between ages 55 and 64 years was associated with a substantial reduction of CRC incidence and mortality.
Background
We assessed feasibility, short-term oncologic safety, and short-term outcomes in robotic total mesorectal excision (R-TME) for rectal cancer compared with laparoscopic TME.
Methods
From ...March 2008 to June 2009, 50 patients with proven middle/lower rectal adenocarcinoma underwent minimally invasive TME; 25 received R-TME. The groups were balanced (R-TME versus L-TME) in terms of age (median 69 versus 62 years;
p
= 0.8), disease stage, and body mass index (median 23 versus 26.5 kg/m
2
;
p
= 0.06). There were 37 (74%) anterior resections and 13 (26%) abdominoperineal resections. Twenty-three (46%) patients received preoperative radiochemotherapy. The robot was a four-arm Da Vinci S (Intuitive Surgical, Sunnyvale, CA, USA).
Results
Median operating time (R-TME versus L-TME) was 240 versus 237 min (
p
= 0.2); first bowel movement was 2 versus 3 days (
p
= 0.5); median hospital stay was 6.5 versus 6 days (
p
= 0.4). Major complications with reoperation were two in R-TME (one anastomotic leakage, one small bowel perforation) and three in L-TME (one colonic ischemia, two anastomotic leakage). Postoperative complications were 16% versus 24% (
p
= 0.5). A median of 18 versus 17 (
p
= 0.7) lymph nodes were retrieved; distal resection margins were disease free in both groups; circumferential margin was involved (<1.0 mm) in one (4%) of L-TME. There were 0 versus 1 (5%) conversions to laparotomy.
Conclusions
R-TME in rectal cancer is feasible, with short-term oncologic and other outcomes similar to those of L-TME. The greater maneuverability and visibility afforded by the robotic approach are attractive. Future studies should more systematically address advantages and costs of R-TME.
Aliment Pharmacol Ther 2012; 35: 222–237
Summary
Background Previous reviews of bowel preparation for colonoscopy have given contradictory answers.
Aim To provide a definitive insight, using ...PRISMA‐compliant methodology.
Methods A comprehensive literature review identified randomised controlled trials comparing bowel preparation regimens. Data for quality of bowel preparation were pooled in multiple meta‐analyses exploring a range of inclusion criteria.
Results A total of 104 qualifying studies were identified, the majority of which involved comparisons of sodium phosphate (NaP) or polyethylene glycol (PEG). There was no significant difference demonstrated between NaP and PEG overall (OR = 0.82; 95% CI = 0.56–1.21; P = 0.36). Cumulative meta‐analysis demonstrated that this conclusion has been qualitatively similar since the mid 1990s, with little quantitative change for the past 10 years. Amongst studies with previous day dosing in both study arms there was a significant advantage in favour of PEG (OR = 1.78; 95% CI = 1.13–2.81; P = 0.006). Studies focussing on results in the proximal colon also favoured PEG (OR = 2.36; 95% CI = 1.16–4.77; P = 0.012). PEG was also significantly more effective than non‐NaP bowel preparation regimens (OR = 2.02; 95% CI = 1.08–3.78; P = 0.03). Other comparisons showed no significant difference between regimens.
Conclusions Although there is no compelling evidence favouring either of the two most commonly used bowel preparation regimens, this may reflect shortcomings in study design. Where studies have ensured comparable dosage, or the clinically relevant outcome of proximal bowel clearance is considered, PEG‐based regimens offer the most effective option.
Fluorouracil-based adjuvant chemotherapy in gastric cancer has been reported to be effective by several meta-analyses. Perioperative chemotherapy in locally advanced resectable gastric cancer (RGC) ...has been reported improving survival by two large randomized trials and recent meta-analyses but the role of neoadjuvant chemotherapy and optimal regimen remains to be determined. We compared a neoadjuvant with adjuvant docetaxel-based regimen in a prospective randomized phase III trial, of which we present the 10-year follow-up data.
Patients with cT3–4 anyN M0 or anyT cN1–3 M0 gastric carcinoma, staged with endoscopic ultrasound, computed tomography, bone scan, and laparoscopy, were assigned to receive four 21-day/cycles of docetaxel 75 mg/m2 day 1, cisplatin 75 mg/m2 day 1, and fluorouracil 300 mg/m2/day over days 1–14, either before (arm A) or after (arm B) gastrectomy. Event-free survival was the primary end point, whereas secondary end points included overall survival, toxicity, down-staging, pathological response, quality of life, and feasibility of adjuvant chemotherapy.
This trial was activated in November 1999 and closed in November 2005 due to insufficient accrual. Of the 70 enrolled patients, 69 were randomized, 34 to arm A and 35 to arm B. No difference in EFS (2.5 years in both arms) or OS (4.3 versus 3.7 years, in arms A and B, respectively) was found. A higher dose intensity of chemotherapy was observed in arm A and more frequent chemotherapy-related serious adverse events occurred in arm B. Surgery was safe after preoperative chemotherapy. A 12% pathological complete response was observed in arm A.
Docetaxel/cisplatin/fluorouracil chemotherapy is promising in preoperative setting of locally advanced RGC. The early stopping could mask the real effectiveness of neoadjuvant treatment. However, the complete pathological tumour responses, feasibility, and safe surgery warrant further investigation of a taxane-based regimen in the preoperative setting.
Abstract Colonoscopy constitutes the principal investigation for colo-rectal neoplasms due to its ability to detect and remove most of precancerous lesions; due to the ongoing or planned colon cancer ...screening programs in many European countries we should expect an enormous increase in colonoscopic demand over the next few years. Diagnostic accuracy and therapeutic safety of colonoscopy strictly depends upon the quality of bowel cleansing which is often perceived as the most unpleasant part of the procedure in individuals undergoing this examination. The ideal preparation for colonoscopy should reliably empty the colon from all faecal material allowing the optimal visualization of the entire colonic mucosa without causing great patient's discomfort nor significant shifts in fluids or electrolytes. Standard PEG solutions and sodium phoshate (NaP) compounds are the most frequently used preparations; both are accepted and relatively well tolerated by the majority of patients undergoing colonoscopy; however, NaP compounds should be avoided in elderly subjects as well as in those with congestive heart failure, renal and hepatic insufficiency or taking diuretics, ACE inhibitors or angiotensin receptor blockers, since they can induce severe electrolyte and/or fluid disturbances. Standard PEG solutions are often taken incompletely due to the low palatability and the high volume of liquids required which induce nausea and vomiting with negative consequences in terms of colon cleansing. Reduced volume and better palatability of PEG solutions, such as those obtained with the newest PEG formulations, as well as improved patient education concerning the importance of bowel cleansing could undoubtedly increase compliance with oral bowel preparations and promote adherence to colo-rectal cancer screening programs.
Diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP/ES) can be associated with unforeseeable complications, especially when involving postprocedural pancreatitis. The aim ...of the study was to investigate risk factors for complications of ERCP/ES in a prospective multicentric study.
One hundred fifty variables were prospectively collected at time of ERCP/ES and before hospital discharge over 2 years, in consecutive patients undergoing the procedure in nine endoscopic units in the Lombardy region of Italy. More than 150 ERCPs were performed in each center per year by a single operator or by a team of no more than three endoscopists.
Two thousand four hundred sixty-two procedures were performed; 18 patients were discharged because the papilla of Vater was not reached (duodenal obstruction, previous gastrectomy, etc.). Two thousand four hundred forty-four procedures were considered in 2103 patients. Overall complications occurred in 121 patients (4.95% of cases): pancreatitis in 44 patients (1.8%), hemorrhage in 30 (1.13%), cholangitis in 14 (0.57%), perforation during ES in 14 (0.57%), and others in 14 (0.57%); deaths occurred in three patients (0.12%). In multivariate analysis, the following were significant risk factors: a) for pancreatitis, age (< or = 60 yr), use of precutting technique, and failed clearing of biliary stones, and b) for hemorrhage, precut sphincterotomy and obstruction of the orifice of the papilla of Vater.
The results of our study further contribute to the assessment of risk factors for complications related to ERCP/ES. It is crucial to identify high risk patients to reduce complications of the procedures.
Background: Although there is general consensus concerning the efficacy of colorectal cancer screening, there is a lack of agreement about which routine screening strategy should be adopted. We ...compared the participation and detection rates achievable through different strategies of colorectal cancer screening. Methods: From November 1999 through June 2001 we conducted a multicenter, randomized trial in Italy among a sample of 55–64 year olds in the general population who had an average risk of colorectal cancer. People with previous colorectal cancer, adenomas, inflammatory bowel disease, a recent (≤2 years) colorectal endoscopy or fecal occult blood test (FOBT), or two first-degree relatives with colorectal cancer were excluded. Eligible subjects were randomly assigned, within the roster of their general practitioner, to 1) biennial FOBT (delivered by mail), 2) biennial FOBT (delivered by general practitioner or a screening facility), 3) patient's choice of FOBT or “once-only” sigmoidoscopy, 4) “once-only” sigmoidoscopy, or 5) sigmoidoscopy followed by biennial FOBT. An immunologic FOBT was used. Participation and detection rates of the strategies tested were compared using multivariable logistic regression models that adjusted for age, sex, and screening center. All statistical tests were two-sided. Results: Of 28 319 people sampled, 1637 were excluded and 26 682 were randomly assigned to a screening arm. After excluding undelivered letters (n = 427), the participation rates for groups 1, 2, 3, 4, and 5 were 30.1% (682/2266), 28.1% (1654/5893), 27.1% (970/3579), 28.1% (1026/3650), and 28.1% (3049/10 867), respectively. Of the 2858 subjects screened by FOBT, 122 (4.3%) had a positive test result, 10 (3.5 per 1000) had colorectal cancer, and 39 (1.4%) had an advanced adenoma. Among the 4466 subjects screened by sigmoidoscopy, 341 (7.6%) were referred for colonoscopy, 18 (4 per 1000) had colorectal cancer, and 229 (5.1%) harbored an advanced adenoma. Conclusions: The participation rates were similar for sigmoidoscopy and FOBT. The detection rate for advanced neoplasia was three times higher following screening by sigmoidoscopy than by FOBT.
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