Single CT colonography versus three rounds of faecal immunochemical test for population-based screening of colorectal cancer (SAVE): a randomised controlled trial.

BACKGROUND: Colorectal cancer screening is recommended for people aged 50-75 years, but the optimal screening test and strategy are not established. We aimed to compare single CT colonography versus three faecal immunochemical test (FIT) rounds for population-based screening of colorectal cancer. METHODS: This randomised controlled trial was done in Florence, Italy. Adults aged 54-65 years, never screened for colorectal cancer, were randomly assigned (1:2) by simple randomisation and invited by post to either a single CT colonography (CT colonography group) or three FIT rounds (FIT group; each round was done 2 years apart). Exclusion criteria included previous colorectal cancer, advanced adenoma, or inflammatory bowel disease, colonoscopy within the last 5 years or FIT within the last 2 years, and severe medical conditions. Participants who had a colonic mass or at least one polyp of 6 mm or more in diameter in the CT colonography group and those who had at least 20 µg haemoglobin per g faeces in the FIT group were referred for work-up optical colonoscopy. The primary outcome was detection rate for advanced neoplasia. Outcomes were assessed in the modified intention-to-screen and per-protocol populations. The trial is registered with ClinicalTrials.gov, NCT01651624. FINDINGS: From Dec 12, 2012, to March 5, 2018, 14 981 adults were randomised and invited to screening interventions. 5242 (35·0%) individuals (2809 [53·6%] women and 2433 [46·4%] men) were assigned to the CT colonography group and 9739 (65·0%) individuals (5208 [53·5%] women and 4531 [46·5%] men) were assigned to the FIT group. Participation in the screening intervention was lower in the CT colonography group (1286 [26·7%] of the 4825 eligible invitees) than it was for the FIT group (6027 [64·9%] of the 9288 eligible invitees took part in at least one screening round, 4573 [49·2%] in at least two rounds, and 3105 [33·4%] in all three rounds). The detection rate for advanced neoplasia of CT colonography was significantly lower than the detection rate after three FIT rounds (1·4% [95% CI 1·1-1·8] vs 2·0% [1·7-2·3]; p=0·0094) in the modified intention-to-screen analysis, but the detection rate was significantly higher in the CT colonography group than in the FIT group (5·2% [95% CI 4·1-6·6] vs 3·1% [2·7-3·6]; p=0·0002]) in the per-protocol analysis. Referral rate to work-up optical colonoscopy (the secondary outcome of the trial) was significantly lower for the CT colonography group than for the FIT group after three FIT rounds (2·7% [95% CI 2·2-3·1] vs 7·5% [7·0-8·1]; p<0·0001) in the modified intention-to-screen analysis, whereas no significant difference was observed in the per-protocol analysis (10·0% [8·4-11·8] vs 11·6% [10·8-12·4]). No major complications were observed in the CT colonography group after screening and work-up optical colonoscopy, whereas three cases of bleeding were reported in the FIT group after work-up optical colonoscopy (two after the first FIT and one after the second FIT). INTERPRETATION: Greater participation makes FIT more efficient than single CT colonography for detection of advanced neoplasia in population screening for colorectal cancer. Nonetheless, higher detection rate in participants and fewer work-up colonoscopies are possible advantages of CT colonography as a screening tool, which might deserve consideration in future trials. FUNDING: Government of Tuscany and Cassa di Risparmio di Firenze Foundation. TRANSLATION: For the Italian translation of the abstract see Supplementary Materials section.

Adenoma detection by Endocuff-assisted versus standard colonoscopy in an organized screening program: the "ItaVision" randomized controlled trial.

BACKGROUND: The Endocuff Vision device (Arc Medical Design Ltd., Leeds, UK) has been shown to increase mucosal exposure, and consequently adenoma detection rate (ADR), during colonoscopy. This nationwide multicenter study assessed possible benefits and harms of using Endocuff Vision in a fecal immunochemical test (FIT)-based screening program. METHODS: Patients undergoing colonoscopy after a FIT-positive test were randomized 1:1 to undergo Endocuff-assisted colonoscopy or standard colonoscopy, stratified by sex, age, and screening history. Primary outcome was ADR. Secondary outcomes were ADR stratified by endoscopists' ADR, advanced ADR (AADR), adenomas per colonoscopy (APC), withdrawal time, and adverse events. RESULTS: 1866 patients were enrolled across 13 centers. After exclusions, 1813 (mean age 60.1 years; male 53.8 %) were randomized (908 Endocuff Vision, 905 standard colonoscopy). ADR was significantly higher in the Endocuff Vision arm (47.8 % vs. 40.8 %; relative risk [RR] 1.17, 95 % confidence interval [CI] 1.06-1.30), with no differences between arms regarding size or morphology. When stratifying for endoscopists' ADR, only low detectors (ADR < 33.3 %) showed a statistically significant ADR increase (Endocuff Vision 41.1 % [95 %CI 35.7-46.7] vs. standard colonoscopy 26.0 % [95 %CI 21.3-31.4]). AADR (24.8 % vs. 20.5 %, RR 1.21, 95 %CI 1.02-1.43) and APC (0.94 vs. 0.77; P  = 0.001) were higher in the Endocuff Vision arm. Withdrawal time and adverse events were similar between arms. CONCLUSION: Endocuff Vision increased ADR in a FIT-based screening program by improving examination of the whole colonic mucosa. Utility was highest among endoscopists with a low ADR.

Patients' experience of screening CT colonography with reduced and full bowel preparation in a randomised trial.

OBJECTIVES: To assess patients' experience of bowel preparation and procedure for screening CT colonography with reduced (r-CTC) and full cathartic preparation (f-CTC) that showed similar detection rate for advanced neoplasia in a randomised trial. METHODS: Six hundred seventy-four subjects undergoing r-CTC and 612 undergoing f-CTC in the SAVE trial were asked to complete two pre-examination questionnaires-(1) Life Orientation Test - Revised (LOT-R) assessing optimism and (2) bowel preparation questionnaire-and a post-examination questionnaire evaluating overall experience of CTC screening test. Items were analysed with chi-square and t test separately and pooled. RESULTS: LOT-R was completed by 529 (78%) of r-CTC and by 462 (75%) of f-CTC participants and bowel preparation questionnaire by 531 (79%) subjects in the r-CTC group and by 465 (76%) in the f-CTC group. Post-examination questionnaire was completed by 525 (78%) subjects in the r-CTC group and by 453 (74%) in the f-CTC group. LOT-R average score was not different between r-CTC (14.27 ± 3.66) and f-CTC (14.54 ± 3.35) (p = 0.22). In bowel preparation questionnaire, 88% of r-CTC subjects reported no preparation-related symptoms as compared to 70% of f-CTC subjects (p < 0.001). No interference of bowel preparation with daily activities was reported in 80% of subjects in the r-CTC group as compared to 53% of subjects in the f-CTC group (p < 0.001). In post-examination questionnaire, average scores for discomfort of the procedure were not significantly different between r-CTC (3.53 ± 0.04) and f-CTC (3.59 ± 0.04) groups (p = 0.84). CONCLUSIONS: Reduced bowel preparation is better tolerated than full preparation for screening CT colonography. KEY POINTS: • Reduced bowel preparation is better tolerated than full preparation for screening CT colonography. • Procedure-related discomfort of screening CT colonography is not influenced by bowel preparation. • Males tolerate bowel preparation and CT colonography screening procedure better than females.

Cost analysis of colorectal cancer screening with CT colonography in Italy.

OBJECTIVE: Unit costs of screening CT colonography (CTC) can be useful for cost-effectiveness analyses and for health care decision-making. We evaluated the unit costs of CTC as a primary screening test for colorectal cancer in the setting of a randomized trial in Italy. METHODS: Data were collected within the randomized SAVE trial. Subjects were invited to screening CTC by mail and requested to have a pre-examination consultation. CTCs were performed with 64- and 128-slice CT scanners after reduced or full bowel preparation. Activity-based costing was used to determine unit costs per-process, per-participant to screening CTC, and per-subject with advanced neoplasia. RESULTS: Among 5242 subjects invited to undergo screening CTC, 1312 had pre-examination consultation and 1286 ultimately underwent CTC. Among 129 subjects with a positive CTC, 126 underwent assessment colonoscopy and 67 were ultimately diagnosed with advanced neoplasia (i.e., cancer or advanced adenoma). Cost per-participant of the entire screening CTC pathway was €196.80. Average cost per-participant for the screening invitation process was €17.04 and €9.45 for the pre-examination consultation process. Average cost per-participant of the CTC execution and reading process was €146.08 and of the diagnostic assessment colonoscopy process was €24.23. Average cost per-subject with advanced neoplasia was €3777.30. CONCLUSIONS: Cost of screening CTC was €196.80 per-participant. Our data suggest that the more relevant cost of screening CTC, amenable of intervention, is related to CTC execution and reading process.

Impact of a new sampling buffer on faecal haemoglobin stability in a colorectal cancer screening programme by the faecal immunochemical test.

Haemoglobin (Hb) stability in faecal samples is an important issue in colorectal cancer screening by the faecal immunochemical test (FIT) for Hb. This study evaluated the performance of the FIT-Hb (OC-Sensor Eiken) used in the Florence screening programme by comparing two different formulations of the buffer, both in an analytical and in a clinical setting. In the laboratory simulation, six faecal pools (three in each buffer type) were stored at different temperatures and analysed eight times in 10 replicates over 21 days. In the clinical setting, 7695 screenees returned two samples, using both the old and the new specimen collection device (SCD). In the laboratory simulation, 5 days from sample preparation with the buffer of the old SCD, the Hb concentration decreased by 40% at room temperature (25°C, range 22-28°C) and up to 60% at outside temperature (29°C, range 16-39°C), whereas with the new one, Hb concentration decreased by 10%. In the clinical setting, a higher mean Hb concentration with the new SCD compared with the old one was found (6.3 vs. 5.0 µg Hb/g faeces, respectively, P<0.001); no statistically significant difference was found in the probability of having a positive result in the two SCDs. Better Hb stability was observed with the new buffer under laboratory conditions, but no difference was found in the clinical performance. In our study, only marginal advantages arise from the new buffer. Improvements in sample stability represent a significant target in the screening setting.

Robotic rectal surgery: State of the art.

Laparoscopic rectal surgery has demonstrated its superiority over the open approach, however it still has some technical limitations that lead to the development of robotic platforms. Nevertheless the literature on this topic is rapidly expanding there is still no consensus about benefits of robotic rectal cancer surgery over the laparoscopic one. For this reason a review of all the literature examining robotic surgery for rectal cancer was performed. Two reviewers independently conducted a search of electronic databases (PubMed and EMBASE) using the key words "rectum", "rectal", "cancer", "laparoscopy", "robot". After the initial screen of 266 articles, 43 papers were selected for review. A total of 3013 patients were included in the review. The most commonly performed intervention was low anterior resection (1450 patients, 48.1%), followed by anterior resections (997 patients, 33%), ultra-low anterior resections (393 patients, 13%) and abdominoperineal resections (173 patients, 5.7%). Robotic rectal surgery seems to offer potential advantages especially in low anterior resections with lower conversions rates and better preservation of the autonomic function. Quality of mesorectum and status of and circumferential resection margins are similar to those obtained with conventional laparoscopy even if robotic rectal surgery is undoubtedly associated with longer operative times. This review demonstrated that robotic rectal surgery is both safe and feasible but there is no evidence of its superiority over laparoscopy in terms of postoperative, clinical outcomes and incidence of complications. In conclusion robotic rectal surgery seems to overcome some of technical limitations of conventional laparoscopic surgery especially for tumors requiring low and ultra-low anterior resections but this technical improvement seems not to provide, until now, any significant clinical advantages to the patients.

Robotic vs laparoscopic distal gastrectomy with D2 lymphadenectomy for gastric cancer: a retrospective comparative mono-institutional study.

BACKGROUND: Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. The present study was designed to compare robotic and laparoscopic distal gastrectomy in the treatment of gastric cancer. METHODS: Between June 2008 and September 2015, 41 laparoscopic and 30 robotic distal gastrectomies were performed by a single surgeon at the same institution. Clinicopathological characteristics of the patients, surgical performance, postoperative morbidity/mortality and pathologic data were prospectively collected and compared between the laparoscopic and robotic groups by the Chi-square test and the Mann-Whitney test, as indicated. RESULTS: There were no significant differences in patient characteristics between the two groups. Mean tumor size was larger in the laparoscopic than in the robotic patients (5.3 ± 0.5 cm and 3.0 ± 0.4 cm, respectively; P = 0.02). However, tumor stage distribution was similar between the two groups. The mean number of dissected lymph nodes was higher in the robotic than in the laparoscopic patients (39.1 ± 3.7 and 30.5 ± 2.0, respectively; P = 0.02). The mean operative time was 262.6 ± 8.6 min in the laparoscopic group and 312.6 ± 15.7 min in the robotic group (P < 0.001). The incidences of surgery-related and surgery-unrelated complications were similar in the laparoscopic and in the robotic patients. There were no significant differences in short-term clinical outcomes between the two groups. CONCLUSIONS: Within the limitation of a small-sized, non-randomized analysis, our study confirms that robotic distal gastrectomy is a feasible and safe surgical procedure. When compared with conventional laparoscopy, robotic surgery shows evident benefits in the performance of lymphadenectomy with a higher number of retrieved and examined lymph nodes.

Reduced and Full-Preparation CT Colonography, Fecal Immunochemical Test, and Colonoscopy for Population Screening of Colorectal Cancer: A Randomized Trial.

BACKGROUND: Population screening for colorectal cancer (CRC) is widely adopted, but the preferred strategy is still under debate. We aimed to compare reduced (r-CTC) and full cathartic preparation CT colonography (f-CTC), fecal immunochemical test (FIT), and optical colonoscopy (OC) as primary screening tests for CRC. METHODS: Citizens of a district of Florence, Italy, age 54 to 65 years, were allocated (8:2.5:2.5:1) with simple randomization to be invited by mail to one of four screening interventions: 1) biennial FIT for three rounds, 2) r-CTC, 3) f-CTC, 4) OC. Patients tested positive to FIT or CTC (at least one polyp ≥6mm) were referred to OC work-up. The primary outcomes were participation rate and detection rate (DR) for cancer or advanced adenoma (advanced neoplasia). All statistical tests were two-sided. RESULTS: Sixteen thousand eighty-seven randomly assigned subjects were invited to the assigned screening test. Participation rates were 50.4% (4677/9288) for first-round FIT, 28.1% (674/2395) for r-CTC, 25.2% (612/2430) for f-CTC, and 14.8% (153/1036) for OC. All differences between groups were statistically significant (P = .047 for r-CTC vs f-CTC; P < .001 for all others). DRs for advanced neoplasia were 1.7% (79/4677) for first-round FIT, 5.5% (37/674) for r-CTC, 4.9% (30/612) for f-CTC, and 7.2% (11/153) for OC. Differences in DR between CTC groups and FIT were statistically significant (P < .001), but not between r-CTC and f-CTC (P = .65). CONCLUSIONS: Reduced preparation increases participation in CTC. Lower attendance and higher DR of CTC as compared with FIT are key factors for the optimization of its role in population screening of CRC.

Survival after laparoscopic and open surgery for colon cancer: a comparative, single-institution study.

BACKGROUND: Some recent studies have suggested that laparoscopic surgery for colorectal cancer may provide a potential survival advantage when compared with open surgery. This study aimed to compare cancer-related survivals of patients who underwent laparoscopic or open resection of colon cancer in the same, high volume tertiary center. METHODS: Patients who had undergone elective open or laparoscopic surgery for colon cancer between January 2002 and December 2010 were analyzed. A clinical database was prospectively compiled. Survival analysis was calculated by using the Kaplan-Meier method. RESULTS: A total of 460 resections were performed. There were no significant differences between the laparoscopic (n = 227) and the open group (n = 233) apart from tumor stage: stage I tumors were more frequent in the laparoscopic group whereas stage II tumors were more frequent in the open group. The mean number of harvested lymph nodes was significantly higher in the laparoscopic than in the open group (20.0 ± 0.7 vs 14.2 ± 0.5, P < 0.01). The 5-year cancer-related survival for patients undergoing laparoscopic resection was significantly higher than that following open resections (83.1% vs 68.5%, P = 0.01). By performing a stage-to-stage comparison, we found that the improvement in survival in the laparoscopic group occurred mainly in patients with stage II tumors. CONCLUSIONS: Our study shows a survival advantage for patients who had undergone laparoscopic surgery for stage II colon cancer. This may be correlated with a higher number of harvested lymph nodes and thus a better stage stratification of these patients.

Laparoscopic total gastrectomy using the transorally inserted anvil (OrVil™): a preliminary, single institution experience.

Laparoscopic total gastrectomy (LTG) is not a commonly performed procedure due to the difficulty associated with surgical reconstruction. We present our preliminary results after intracorporeal circular stapling esophagojejunostomy using the newly developed transorally inserted anvil (OrVil™, Covidien, MA, USA). Between 2008 and June 2013, 51 patients underwent laparoscopic gastrectomy with D2 lymph node dissection for gastric cancer. A total of 12 patients underwent LTG: of these, 5 received an intracorporeal linear side-to-side esophagojejunal anastomosis and the remaining 7 underwent intracorporeal circular stapling esophagojejunostomy using the OrVil™ system. Short-term outcomes were compared between the two groups. There were no intraoperative complications or conversions to open surgery in any patients. The mean operative time was significantly shorter in the OrVil™ than in the side-to-side group (261.4 ± 12.0 vs 333.0 ± 15.0 minutes, respectively, p = 0.005). Postoperative fluorography revealed no anastomosis leakage or stenosis in either groups. All patients resumed an oral liquid diet on postoperative day 5 and the mean postoperative hospital stay was 9 days. Intracorporeal circular stapling esophagojejunostomy using the OrVil™ system is technically feasible and safe in LTG. This technique may be considered a simple and time-saving alternative to the side-to-side linear esophagojejunostomy.

Screening for colorectal cancer with FOBT, virtual colonoscopy and optical colonoscopy: study protocol for a randomized controlled trial in the Florence district (SAVE study).

BACKGROUND: Colorectal cancer (CRC) is the most frequent cancer in Europe. Randomized clinical trials demonstrated that screening with fecal occult blood test (FOBT) reduces mortality from CRC. Accordingly, the European Community currently recommends population-based screening with FOBT. Other screening tests, such as computed tomography colonography (CTC) and optical colonoscopy (OC), are highly accurate for examining the entire colon for adenomas and CRC. Acceptability represents a critical determinant of the impact of a screening program. We designed a randomized controlled trial to compare participation rate and diagnostic yield of FOBT, CTC with computer-aided diagnosis, and OC as primary tests for population-based screening. METHODS/DESIGN: A total of 14,000 subjects aged 55 to 64 years, living in the Florence district and never screened for CRC, will be randomized in three arms: group 1 (5,000 persons) invited to undergo CTC (divided into: subgroup 1A with reduced cathartic preparation and subgroup 1B with standard bowel preparation); group 2 (8,000 persons) invited to undergo a biannual FOBT for three rounds; and group 3 (1,000 persons) invited to undergo OC. Subjects of each group will be invited by mail to undergo the selected test. All subjects with a positive FOBT or CTC test (that is, mass or at least one polyp ≥ 6 mm) will be invited to undergo a second-level OC. Primary objectives of the study are to compare the participation rate to FOBT, CTC and OC; to compare the detection rate for cancer or advanced adenomas of CTC versus three rounds of biannual FOBT; to evaluate referral rate for OC induced by primary CTC versus three rounds of FOBT; and to estimate costs of the three screening strategies. A secondary objective of the study is to create a biological bank of blood and stool specimens from subjects undergoing CTC and OC. DISCUSSION: This study will provide information about participation/acceptability, diagnostic yield and costs of screening with CTC in comparison with the recommended test (FOBT) and OC. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01651624.

Computed tomographic colonography in subjects with positive faecal occult blood test refusing optical colonoscopy.

BACKGROUND: Refusal of colonoscopy is a drawback of colorectal cancer screening programmes based on faecal occult blood test. Computed-tomographic-colonography is generally more accepted than colonoscopy. AIM: To compare adherence to computed-tomographic-colonography and second-invitation colonoscopy in subjects with positive faecal test refusing colonoscopy. METHODS: We performed a prospective study in 198 subjects with positive faecal test who refused first referral to colonoscopy in one endoscopy service of the Florence screening programme. Subjects were randomly invited to computed-tomographic-colonography (n = 100) or re-invited to colonoscopy (n = 98). Mail invitation was followed by a questionnaire administered by phone. Computed-tomographic-colonography findings were verified with colonoscopy. RESULTS: 32 subjects could not be reached, 71 (35.9%) had undergone colonoscopy on their own; 4 were excluded for contraindications; 30/48 (62.5%) in the computed-tomographic-colonography arm and 11/43 (25.6%) in the colonoscopy arm accepted the proposed examinations (p < 0.001). Four advanced adenomas and 1 cancer were found in the 28 subjects who ultimately underwent computed-tomographic-colonography and 2 advanced adenomas and 2 cancers in the 9 subjects who ultimately underwent second-invitation colonoscopy. CONCLUSION: Subjects with positive faecal occult blood test refusing colonoscopy show a higher adherence to computed-tomographic-colonography than to second invitation colonoscopy.

Totally laparoscopic versus open gastrectomy for gastric cancer: a matched cohort study.

BACKGROUND: The role of laparoscopic surgery for the treatment of gastric cancer is still controversial, particularly in terms of oncologic efficacy. The aim of this study was to compare short-term outcomes of laparoscopic and open resection for gastric cancer at a single Western institution. SUBJECTS AND METHODS: This study was designed as a matched cohort study from a prospective gastric cancer database. Forty-one patients undergoing laparoscopic gastrectomy for gastric cancer between June 2008 and January 2012 were matched with 41 patients undergoing open gastrectomy in the same time period. Patient pairing was done according to age, gender, type of gastrectomy (subtotal or total), and tumor stage via a randomized statistical method. The short-term outcomes and oncologic adequacy of the laparoscopic and open procedures were compared. A D2 lymph node dissection was performed in the majority of patients in both groups. RESULTS: The two study groups were similar with respect to patient and tumor characteristics. Laparoscopic procedures were associated with a decreased blood loss (118.7 versus 312.4 mL, P<.005), incidence of surgery-unrelated complications (3 versus 9 patients, P<.05), and duration of hospital stay (8.1 versus 11.5 days, P<.05) but increased operative time for both subtotal (223.5 versus 158.2 minutes, P<.001) and total (298.1 versus 185.5 minutes, P<.001) gastrectomies. The mean number of retrieved lymph nodes after D2 dissection was similar: 30.0 for laparoscopic and 29.7 for open patients. CONCLUSIONS: Within the limitations of a nonrandomized analysis, this study shows that the laparoscopic approach is a safe and oncologically adequate option for the treatment of gastric cancer, which compares favorably with open gastrectomy in short-term outcomes.

Single-incision laparoscopic colectomy: technical aspects and short-term results.

Single-incision laparoscopic surgery (SILS) is currently regarded as the next major advance in the progress of minimally invasive techniques in colorectal surgery. We describe our initial experience using SILS for the management of colorectal disease and present preliminary short-term results. Between February 2010 and April 2011, 7 patients (4 females and 3 males, mean age 55 years, range 32­74) underwent SILS for either benign or malignant colorectal disease. Preoperative diagnosis was diverticular disease of the sigmoid colon in two patients, malignant polyps of the sigmoid colon in two other patients and large villous tumor of the right colon in three patients. Surgical procedures, 4 anterior resections of the rectum and 3 right hemicolectomies, were performed through a 3 cm single umbilical incision using a SILS multi port device with conventional or articulated laparoscopic instruments. There were no intraoperative complications or conversions in the standard laparoscopic procedure. The mean operative time for anterior resections was 160.0 ± 10.6 min, whereas it was 160.6 ± 20 for right hemicolectomies. Blood loss was minimal. No postoperative complications were reported in any of the patients. The overall mean hospital stay was 4.8 ± 0.2 days (range 4­5). For the subset of patients with malignant or pre-malignant disease, the mean number of retrieved lymph nodes was 15.6 ± 4.4 (range 6­31). Cosmetic results were considered excellent by all the patients after 15 days. In conclusion, our preliminary experience shows that SILS for colorectal disease is feasible and safe with potential reproducible oncologic results.

Familial risk of colorectal cancer in subjects attending an organised screening programme.

BACKGROUND: First degree relatives of colorectal cancer patients are at increased risk for the same disease. AIMS: To evaluate the prevalence of familial risk and its association with the occurrence of pathological significant lesions in subjects with positive faecal occult blood testing leading to colonoscopy. METHODS: Faecal occult blood testing is offered biennially to subjects aged 50-70. Subjects with a positive faecal test are invited to undergo colonoscopy. Familial history for colorectal cancer in subjects undergoing colonoscopy was routinely recorded. RESULTS: From 1995 to 2009, 4833 screenees with positive faecal occult blood test undergoing colonoscopy were enrolled. Twelve percent reported a positive first degree family history. Multivariate analysis evidenced that the probability of detecting pathological significant lesions was statistically associated with age, gender, type of test, repeated or first screening, and having at least 1 first degree relative with colorectal cancer. CONCLUSIONS: Subjects attending colonoscopy reporting a positive first degree family history are at increased risk for pathologically significant lesions.