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Mesorectal excision is the international standard surgical procedure for lower rectal cancer. However, lateral pelvic lymph node metastasis occasionally occurs in patients with clinical stage II or stage III rectal cancer, and therefore mesorectal excision with lateral lymph node dissection is the standard procedure in Japan. We did a randomised controlled trial to confirm that the results of mesorectal excision alone are not inferior to those of mesorectal excision with lateral lymph node dissection. This study was undertaken at 33 major hospitals in Japan. Eligibility criteria included histologically proven rectal cancer of clinical stage II or stage III, with the main lesion located in the rectum with the lower margin below the peritoneal reflection, and no lateral pelvic lymph node enlargement. After surgeons had confirmed macroscopic R0 resection by mesorectal excision, patients were intraoperatively randomised to mesorectal excision alone or with lateral lymph node dissection. The groups were balanced by a minimisation method according to clinical N staging (N0 or N1, 2), sex, and institution. Allocated procedure was not masked to investigators or patients. This study is now in the follow-up stage. The primary endpoint is relapse-free survival and will be reported after the primary analysis planned for 2015. Here, we compare operation time, blood loss, postoperative morbidity (grade 3 or 4), and hospital mortality between the two groups. Analysis was by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT00190541. 351 patients were randomly assigned to mesoretcal excision with lateral lymph node dissection and 350 to mesorectal excision alone, between June 11, 2003, and Aug 6, 2010. One patient in the mesorectal excision alone group underwent lateral lymph node dissection, but was analysed in their assigned group. Operation time was significantly longer in the mesorectal excision with lateral lymph node dissection group (median 360 min, IQR 296–429) than in the mesorectal excision alone group (254 min, 210–307, p<0·0001). Blood loss was significantly higher in the mesorectal excision with lateral lymph node dissection group (576 mL, IQR 352–900) than in the mesorectal excision alone group (337 mL, 170–566; p<0·0001). 26 (7%) patients in the mesorectal excision with lateral lymph node dissection group had lateral pelvic lymph node metastasis. Grade 3–4 postoperative complications occurred in 76 (22%) patients in the mesorectal excision with lateral lymph node dissection group and 56 (16%) patients in the mesorectal excision alone group. The most common grade 3 or 4 postoperative complication was anastomotic leakage (18 [6%] patients in the mesorectal excision with lateral lymph node dissection group vs 13 [5%] in the mesorectal excision alone group; p=0·46). One patient in the mesorectal excision with lateral lymph node dissection group died of anastomotic leakage followed by sepsis. Mesorectal excision with lateral lymph node dissection required a significantly longer operation time and resulted in significantly greater blood loss than mesorectal excision alone. The primary analysis will help to show whether or not mesorectal excision alone is non-inferior to mesorectal excision with lateral lymph node dissection. National Cancer Center, Ministry of Health, Labour and Welfare of Japan.

Decreased surgical site infections (SSIs) and morbidity have been reported with mechanical and oral antibiotic bowel preparation (MOABP) compared with no bowel preparation (NBP) in colonic surgery. Several societies have recommended routine use of MOABP in patients undergoing colon resection on the basis of these data. Our aim was to investigate this recommendation in a prospective randomised context. In this multicentre, parallel, single-blinded trial, patients undergoing colon resection were randomly assigned (1:1) to either MOABP or NBP in four hospitals in Finland, using a web-based randomisation technique. Randomly varying block sizes (four, six, and eight) were used for randomisation, and stratification was done according to centre. The recruiters, treating physicians, operating surgeons, data collectors, and analysts were masked to the allocated treatment. Key exclusion criteria were need for emergency surgery; bowel obstruction; colonoscopy planned during surgery; allergy to polyethylene glycol, neomycin, or metronidazole; and age younger than 18 years or older than 95 years. Study nurses opened numbered opaque envelopes containing the patient allocated group, and instructed the patients according to the allocation group to either prepare the bowel, or not prepare the bowel. Patients allocated to MOABP prepared their bowel by drinking 2 L of polyethylene glycol and 1 L of clear fluid before 6 pm on the day before surgery and took 2 g of neomycin orally at 7 pm and 2 g of metronidazole orally at 11 pm the day before surgery. The primary outcome was SSI within 30 days after surgery, analysed in the modified intention-to-treat population (all patients who were randomly allocated to and underwent elective colon resection with an anastomosis) along with safety analyses. The trial is registered with ClinicalTrials.gov, NCT02652637, and EudraCT, 2015–004559–38, and is closed to new participants. Between March 17, 2016, and Aug 20, 2018, 738 patients were assessed for eligibility. Of the 417 patients who were randomised (209 to MOABP and 208 to NBP), 13 in the MOABP group and eight in the NBP were excluded before undergoing colonic resection; therefore, the modified intention-to-treat analysis included 396 patients (196 for MOABP and 200 for NBP). SSI was detected in 13 (7%) of 196 patients randomised to MOABP, and in 21 (11%) of 200 patients randomised to NBP (odds ratio 1·65, 95% CI 0·80–3·40; p=0·17). Anastomotic dehiscence was reported in 7 (4%) of 196 patients in the MOABP group and in 8 (4%) of 200 in the NBP group, and reoperations were necessary in 16 (8%) of 196 compared with 13 (7%) of 200 patients. Two patients died in the NBP group and none in the MOABP group within 30 days. MOABP does not reduce SSIs or the overall morbidity of colon surgery compared with NBP. We therefore propose that the current recommendations of using MOABP for colectomies to reduce SSIs or morbidity should be reconsidered. Vatsatautien Tutkimussäätiö Foundation, Mary and Georg Ehrnrooth's Foundation, and Helsinki University Hospital research funds.

Background Our study aimed to determine the effect of probiotic consumption containing six viable microorganisms of 30 × 10 10  cfu Lactobacillus and Bifidobacteria strains for six months on clinical outcomes and inflammatory cytokines (TNF-α, IFN-γ, IL-6, IL-10, IL-12, IL-17A, IL-17C and IL-22) in patients with colorectal cancer. Methods Fifty-two patients with colorectal cancer were randomized at four weeks after surgery to receive either a placebo ( n  = 25) or 30 billion colony-forming unit (CFU) of a mixture of six viable strains including 107 mg of Lactobacillus acidophilus BCMC® 12,130, Lactobacillus lactis BCMC® 12,451, Lactobacillus casei subsp BCMC® 12,313, Bifidobacterium longum BCMC® 02120, Bifidobacterium bifidum BCMC® 02290 and Bifidobacterium infantis BCMC® 02129 ( n  = 27). Patients were instructed to take the product orally twice daily for six months. Infection status, diarrhea or hospital admission were recorded throughout the study. Blood was taken pre- and post-intervention to measure TNF-α, IFN-γ, IL-6, IL-10, IL-12, IL-17A, IL-17C and IL-22 using ELISA multiplex kit. Results The majority of cases (~ 70%) were in Duke’s C colorectal cancer for both groups. No surgical infection occurred and no antibiotics were required. Chemotherapy induced diarrhea was observed in both groups. Significant reduction in the level of pro-inflammatory cytokine, TNF-α, IL-6, IL-10, IL-12, IL-17A, IL-17C and IL-22 were observed in CRC patients who received probiotics as compared to pre-treatment level ( P  < 0.05). However, there was no significant difference in the IFN-γ in both groups. Conclusions We have shown that probiotics containing six viable microorganisms of Lactobacillus and Bifidobacteria strains are safe to be consumed at four weeks after surgery in colorectal cancer patients and have reduced pro-inflammatory cytokines (except for IFN-gamma). Probiotic may modify intestinal microenvironment resulting in a decline in pro-inflammatory cytokines. Trial registration NCT03782428 ; retrospectively registered on 20th December 2018.

Cold snare polypectomy (CSP) is safe and effective for the removal of small adenomas (≤10 mm); however, reported incomplete resection rates (IRRs) vary. The optimal CSP technique, where a wide margin of normal tissue is resected around the target lesion, and snare design have both been hypothesized to reduce the IRR after CSP. We sought to investigate the efficacy of a thin-wire versus thick-wire diameter snare on IRR, using the standardized CSP technique. This was an international multicenter parallel design randomized trial with 17 endoscopists of varying experience (NCT02581254). Patients were randomized in a 1:1 ratio to the use of a thin-wire (0.30 mm) or thick-wire (0.47 mm) snare for CSP of small (≤10 mm) colorectal polyps. The primary end point was the IRR as determined by the histologic assessment of the defect margin after polypectomy. Over 52 months to January 2020, 1,393 patients were eligible. A total of 660 patients with polyps (57.4% male) were randomized to a thin-wire (n = 339) or thick-wire (n = 321) snare. The overall IRR of the cohort was 1.5%. There was no significant difference in the IRR between the thin- and thick-wire arms; relative risk-0.41, 95% CI (0.11-1.56), P = 0.21. No significant differences were observed in the rate of adverse events. In this multicenter randomized trial, CSP is safe and effective with very low rates of incomplete resection independent of the diameter of the snare wire used. This suggests that the optimal operator technique is more important than the snare design alone in minimizing residual adenoma after CSP.

ObjectiveThe aim of this study was to compare the long-term outcomes of robot-assisted right colectomy (RAC) with those for conventional laparoscopy-assisted right surgery (LAC) for treating right-sided colon cancer.BackgroundThe enthusiasm for the robotic techniques has gained increasing interest in colorectal malignancies. However, the role of robotic surgery in the oncologic safety has not yet been defined.MethodsFrom September 2009 to July 2011, 71 patients with right-sided colonic cancer were randomized in the study. Adjuvant therapy and postoperative follow-up were similar in both groups. The primary and secondary endpoints of the study were hospital stay and survival, respectively. Data were analyzed by intention-to-treat principle.ResultsThe RAC and LAC groups did not differ significantly in terms of baseline clinical characteristics. Compared with the LAC group, RAC was associated with longer operation times (195 min vs. 129 min, P < 0.001) and higher cost ($12,235 vs. $10,319, P = 0.013). The median follow-up was 49.23 months (interquartile range 40.63–56.20). The combined 5-year disease-free rate for all tumor stages was 77.4% (95% confidence interval [CI], 60.6–92.1%) in the RAC group and 83.6% (95% CI 72.1–0.97.0%) in the LAC group (P = 0.442). The combined 5-year overall survival rates for all stages were 91.1% (95% CI 78.8–100%) in the RAC group and 91.0% (95% CI 81.3–100%) in the LAC group (P = 0.678). Using multivariate analysis, RAC was not a predictor of recurrence.ConclusionsRAC appears to similar long-term survival as compared with LAC. However, we did not observe any clinical benefits of RAC which could translate to a decrease in expenditures.Trial registry: http://www.ClinicalTrials.gov, number NCT00470951.Graphical abstract

BackgroundThe laparoscopic right hemicolectomy is the standard surgical treatment for right-sided colon cancer. The continuity of the digestive tract is restored through ileocolic anastomosis which can be performed extracorporeally or intracorporeally. The study aimed to compare both anastomotic techniques in laparoscopic right hemicolectomy.Materials and methodsA single-blinded two-armed randomized control trial with 1:1 parallel allocation carried out from 2016 to 2020 in a single center. The follow-up period was 30 days. Compared interventions involved extracorporeal and intracorporeal ileocolic anastomosis in laparoscopic right hemicolectomy. The main outcome of the study was bowel recovery measured as the time to the first stool. Other outcomes involved the time to the first flatus, morbidity, and duration of surgery.ResultsOne hundred and seventeen patients undergoing a laparoscopic right hemicolectomy with curative intent were eligible for the trial. Eight patients refused to participate. One hundred and two patients were analyzed, 52 in the intracorporeal group and 50 in the extracorporeal group. The groups did not differ in terms of cancer stage or body mass index, but did differ in age and sex. Intracorporeal anastomosis was associated with a shorter time to the first stool than extracorporeal, 32.8 h (26.0–43.7) vs. 41.7 (35.9–50.0), p = 0.017. There was no significant difference in the time to the first flatus, 30 h (23.2–42.3) vs. 26.6 h (21.8–37.3), p = 0.165. Similarly, overall complications did not differ (EC 12/50 vs. IC 10/52, p = 0.56). There were no differences in length of surgery, 190 min (150–230) and 190 min (180–220), p = 0.55.ConclusionIntracorporeal ileocolic anastomosis following laparoscopic right hemicolectomy results in slightly faster bowel recovery, with no differences in morbidity and duration of surgery.

Purpose Minimally invasive surgery benefits patients but poor operating ergonomics causes musculoskeletal injuries in surgeons. This randomised controlled trial aims to assess whether robotic-assisted surgery with the open-console Versius® system can reduce surgeons’ ergonomic risks during major colorectal resections. Methods Prospectively registered at ClinicalTrials.gov (NCT05262296) in March 2022. Adult patients requiring a minimally invasive colorectal resection were potentially eligible. Photographs taken at 2-min intervals were analysed using the objective Rapid Entire Body Assessment (REBA) posture analysis scale to calculate intraoperative surgeon ergonomic risk. Secondary outcomes included team communication (Oxford NOTECHS II), surgeon cognitive strain (modified NASA-TLX scale), and clinical outcomes. Results Sixty patients were randomised in a 2:1 ratio (40 robot, 20 laparoscopic). Mean age was 65yrs and 34 (57%) were male. Body Mass Index did not differ between the 2 groups (overall mean 29.0 ± 5) and there were equal proportions of left and right-colonic resections. REBA was significantly lower in the robotic arm (median robot REBA score 3 vs lap REBA 5 [p < 0.001]), equating to an injury risk category drop from “medium” to “low risk”. There were no significant differences in team communication, operative duration, or patient outcomes. Surgeon cognitive strain was lower in robotic cases (mean robot 32.4 ± 10.3 vs lap 45.6 ± 14.3 [p < 0.001]). Conclusions This trial demonstrates that robotic surgery with an open-console system reduces ergonomic risk scores and cognitive strain during colorectal resections, with no apparent detriment to team communication. This may therefore be a safe & feasible solution to the increasing problem of work-related musculoskeletal injuries in surgeons.

Background Single-incision laparoscopic colectomy (SILC) is a newly developed procedure with the benefit of better cosmetic outcome and potentially reduced wound pain compared with conventionally laparoscopic colectomy (CLC). However, the application of SILC requires careful evaluation to prove its benefit and safety. This randomized, controlled study compared the operative outcome of patients who underwent SILC and CLC. Methods Patients who had small cancer (<4 cm) or adenomatous polyp requiring colectomy were randomized to have SILC or CLC. The patients were blinded to the procedures and the postoperative pain was used as the primary outcome measure. All patients had patient-controlled analgesia with intravenous morphine after the operation and the nominal rating score on days 1–3 and day 14 were recorded by research staff, who did not known the types of operations. Other operative outcomes of the two groups of patients also were recorded prospectively and compared. Results There were 25 patients in each group. The patients’ demographics, tumor characteristics, operating time, blood loss, complication rate, number of lymph nodes harvested, and resection margin have no statistically significant difference between the two groups. There was no operative mortality in both groups. The SILC group had consistently lower median pain score than CLC group in the whole postoperative course and the difference was statistically significant on day 1 (0 (0–5) vs. day 3 (0–6) respectively; p  = 0.002) and day 2 (0 (0–3) vs. 2 (0–8) respectively; p  = 0.014). The median hospital stay in the SILC group also was shorter the CLC group. Conclusions In a selected group of patients with small tumor and good operative risk, SILC is a safe alternative to CLC. Single-port laparoscopic colectomy also is associated with the benefits of less postoperative pain and shorter hospital stay than CLC.

ObjectiveThe objective of the study is to evaluate the short-term outcomes of single-incision plus one-port surgery (SILS + 1) compared with conventional laparoscopic surgery (CLS) for colonic cancer.BackgroundAt present, single-incision laparoscopic colectomy remains technically challenging. The use of SILS + 1 as an alternative has gained increasing attention; however, its safety and efficacy remain controversial.Methods and patientsBetween April 2014 and July 2016, 198 patients with clinical stage T1-4aN0-2 M0 rectosigmoid cancer were enrolled. The participants were randomly assigned to either SILS + 1 (n = 99) or CLS (n = 99). The morbidity and mortality within 30 days, operative and pathologic outcomes, postoperative recovery course, inflammation and immune responses, and pain intensity were compared.ResultsThere was no significant difference in overall complications between the two groups (17.2 vs. 16.3%, P = 1.000). The total operating time for the SILS + 1 group was significantly shorter (100.8 ± 30.4 vs. 116.6 ± 36.6, P = 0.002). Blood loss was significantly greater in the CLS group (20 vs. 50, P < 0.001). Thirteen patients (14%) in the CLS group required additional postoperative analgesics, which was significantly more than four patients in the SILS + 1 group. Notably, on postoperative day three, the visual analogue scale score of the CLS group was greater than that of the SILS + 1 group (1.3 ± 1.1 vs. 1.7 ± 1.3, P = 0.023). Tumor diameter, pathologic stage, length of the proximal and distal margins, and number of lymph nodes harvested were similar, other values were also similar between the two groups.ConclusionOur findings suggest that SILS + 1 might be safe and feasible for rectosigmoid cancer when performed by experienced surgeons. It offers minimal invasiveness without compromising oncologic treatment principles. Trial Registration This trial was registered on ClinicalTrials.gov (NCT02117557).

Standard laparoscopic colectomy (SLC) for cancer is a safe, feasible, and oncologically effective procedure with better short-term and similar long-term results of open colectomy. Conversely, owing to technical difficulties in colonic resection and full mesenteric dissection, single-incision laparoscopic colectomy (SILC) has been considered unsuitable for oncologic purposes. We compared the technical feasibility and early clinical outcomes of SLC and SILC for cancer. In this prospective randomized clinical trial, 16 (50%) patients underwent SLC (10 left and 6 right) and 16 (50%) patients underwent SILC (8 left and 8 right). Demographics, preoperative data, and characteristics of the tumor were similar. The mean number of resected lymph nodes was 16 ± 5 in the SLC and 18 ± 6 in the SILC group (P = NS). Surgical time was 124 ± 8 minutes and 147 ± 5 minutes, respectively (P = NS). Surgical mortality was nil and the major morbidity rate was 6.3% in both groups. SILC for cancer is a technically feasible and safe oncologic procedure with short-term results similar to those obtained with a traditional laparoscopic approach.