Surgical stress response in robot-assisted versus laparoscopic surgery for colon cancer (SIRIRALS): randomized clinical trial.

BACKGROUND: Evidence for the routine use of robotic technology and its impact on short-term outcomes in colon cancer surgery is lacking. The aim of this study was to compare the surgically induced systemic stress response and clinical and patient-reported outcomes for patients undergoing robot-assisted or laparoscopic colon cancer surgery. METHODS: In this double-blinded superiority RCT completed between August 2021 and March 2023, patients with stage 1-3 colon cancer were randomized in a 1 : 1 ratio to undergo either robot-assisted or laparoscopic colon cancer surgery. The primary outcome was changes in the systemic stress response, characterized by C-reactive protein expression in the first three postoperative days. Secondary outcomes were intraoperative and postoperative complications and patient-reported outcomes. The latter included quality of recovery-15 and pain intensity using a visual analogue scale. RESULTS: In total, 128 patients were screened for potential inclusion in this study; 50 patients (25 in the robot-assisted group and 25 in the laparoscopic group) were included in the final follow-up and analysis. The postoperative C-reactive protein response was higher on the first postoperative day in the laparoscopic group (mean difference = 19.88 mg/l, 95% c.i. 3.89-35.86; P = 0.045). No statistically significant differences were noted for C-reactive protein expression on the second and third postoperative days. CONCLUSION: Adopting robot-assisted surgery for stage 1-3 colon cancer is associated with a reduction in the surgical stress response. REGISTRATION NUMBER: NCT04687384 (http://www.clinicaltrials.gov).

Long-term Outcomes of Robot-assisted Versus Laparoscopic Surgery for Colon Cancer: A Nationwide Register-based Cohort Study.

OBJECTIVE: To determine long-term survival in patients undergoing robot-assisted surgery (RAS) or laparoscopic surgery (LAS) for colon cancer. BACKGROUND: The potential long-term benefits of RAS compared with LAS for colon cancer are not well examined. Using a register-based approach, we aimed to compare these 2 surgical platforms in an analysis of long-term outcomes, including recurrence-free survival and all-cause- and colon cancer-specific mortality. METHODS: A nationwide register-based cohort study of patients with Union for International Cancer Control stage I-III colon cancer undergoing planned RAS or LAS from 2010 through 2018. Patient demographic, clinical, and pathological data were retrieved from Danish national registers. Survival and recurrence rates were estimated by Cox proportional hazard multivariate regression analysis adjusting for baseline covariates. RESULTS: A total of 7565 patients [LAS=6905 (91%) and RAS=660 (9%)] were included in the complete case survival analysis. Patients undergoing LAS had a significantly increased risk of cancer recurrence [LAS=1178 (17.1%), RAS=82 (12.4%), P =0.002] with a mean follow-up time of 4.93 years (standard deviation 2.47). The survival analysis of recurrence-free survival favored RAS [hazard ratio adjusted =0.80, 95% CI (0.64-1.00), P =0.049]. No associations between the 2 surgical platforms were evident regarding all-cause [hazard ratio adjusted =0.98, 95% CI (0.82-1.17), P =0.783] or colon cancer-specific mortality [hazard ratio adjusted =0.89, 95% CI (0.67-1.18), P =0.405]. CONCLUSIONS: Adopting RAS for colon cancer was associated with improved recurrence-free survival. However, it did not cause a lower all-cause- or colon cancer-specific mortality.

Intracorporeal versus extracorporeal anastomosis in segmental resections for colon cancer: a retrospective cohort study of 328 patients.

PURPOSE: The intracorporeal anastomosis (IA) technique possibly results in enhanced recovery and reduced morbidity rates compared to the extracorporeal anastomosis (EA) technique. This study compared the short-term morbidity rates of IA versus EA in segmental resections for colon cancer. METHOD: We performed a retrospective cohort study of consecutive patients from 2015 to 2020 using the IA or EA technique at a single Danish colorectal center. Comparative outcomes of interest were surgical efficacy and short-term morbidity rates. An inverse probability of treatment weighting (IPTW) analysis of clinically relevant outcomes was conducted to explore potential baseline confounding. RESULTS: We included 328 patients, 129 in the EA and 199 in the IA groups. There was no significant difference in preoperative baseline characteristics between the two groups. The rate of overall surgical (16% in both groups, p = 1.000) and medical complications (EA: 25 (19%) vs. IA: 27 (14%), p = 0.167) was comparable for both groups. The IA technique did not cause a reduction in operative time (EA: 127.0 min [103.0-171.0] vs. IA: 134.0 min [110.0-164.0], p = 0.547). The IPTW analysis indicated that having an IA caused a reduction in the rate of major surgical complications (RRRadjusted = 0.45, 95%CI [0.29-0.69], p = 0.000). CONCLUSION: Adopting IA for colon cancer resulted in similar overall morbidity rates without increasing the duration of the surgical procedure compared to EA. The IA technique had a probable protective effect against developing severe surgical complications. However, this must be interpreted cautiously, limited by the retrospective study design.

Surgical efficacy and learning curves of laparoscopic complete mesocolic excision with intracorporeal anastomosis for right-sided colon cancer: A retrospective two-center cohort study.

BACKGROUND: There is a potential benefit on long-term outcomes following complete mesocolic excision (CME) for right-sided colon cancer when compared to conventional colectomy. This study aims to analyze the learning curve and short-term outcomes of laparoscopic CME with intracorporeal anastomosis (ICA) for right-sided colon cancer in the hands of experienced colorectal surgeons. METHODS: A two-center cohort study of consecutive patients undergoing right-sided colectomy from September 2021 to May 2022 at two tertiary colorectal centers in Denmark. Learning curves of surgical time were estimated using a cumulative sum analysis (CUSUM). RESULTS: A total of 61 patients were included. According to the CUSUM analysis, 32 cases were needed to obtain a peak in operative time, resulting in a decrease in time consumption (group 1/learning phase: 217.2 min [SD 53.6] and group 2/plateau phase 191.6 min [SD 45.1], p = 0.05). There was a nonsignificant reduction in the rates of severe surgical complications (Clavien-Dindo > 3) (13% vs. 7%, p = 0.67) between the two groups, while the length of hospital stay remained constant (median 3.0 days, interquartile range, IQR [2.0; 4.0]). CONCLUSION: The learning curve of laparoscopic CME with ICA for right-sided colon cancer demonstrated that 32 cases were needed to obtain a plateau phase expressed by operative time.

Robot-assisted versus laparoscopic short- and long-term outcomes in complete mesocolic excision for right-sided colonic cancer: a systematic review and meta-analysis.

BACKGROUND: Complete mesocolic excision (CME) surgery is increasingly implemented for the resection of right-sided colonic cancer, possibly resulting in improved 5-year overall and disease-free survival compared to non-CME surgery. However, it is not clear what surgical platform should be used. The aim of this study was to compare the following outcomes between robot-assisted and laparoscopic CME-surgery for right-sided colonic cancer: (i) short-term clinical outcomes, (ii) pathological specimen quality, and (iii) long-term oncological outcomes. METHODS: Medline, Embase, and Cochrane Database of Systematic Reviews were searched from inception until August 2021. Pooled proportions were calculated by applying the inverse variance method. Heterogeneity was explored by I-square and supplemented by sensitivity- and meta-regression analyses. The risk of bias was evaluated by either MINORS or Cochrane's risk-of-bias tool (RoB 2). RESULTS: Fifty-five studies with 5.357 patients (740 robot-assisted and 4617 laparoscopic) were included in the meta-analysis. Overall postoperative morbidity was 17% [95% CI (14-20%)] in the robot-assisted group and 13% [95%CI (12-13%)] in the laparoscopic group. Robot-assisted CME was associated with a shorter hospital stay, lower intraoperative blood loss, a higher amount of harvested lymph nodes, and better 3-year oerall and disease-free survival. MINORS and RoB2 indicated a serious risk of bias across studies included. CONCLUSIONS: This review which includes predominantly non-randomized studies suggests a possible advantage of the robot-assisted CME compared with a laparoscopic technique for several short-term outcomes.

Robotic vs. TaTME Rectal Surgery (ROTA STUDY) Matched Cohort Trial for Mid to Low Rectal Cancer Surgery Evaluation Trial in the Hands of an Experienced Surgeon.

Background: Recent novel surgical techniques for resection of low rectal cancer have been introduced and these approaches have the potential to overcome anatomical limitations like obesity, narrow male pelvis and bulky and low tumours. Two of these procedures are robotic low anterior resection (RLAR) and transanal total mesorectal excision (TaTME).Both approaches have distinct advantages and limitations. There has been no head to head trial comparing RLAR and TaTME for patients with mid to low rectal cancer undergoing surgery by experienced surgeons. Previous studies looking at the oncological outcomes of either TaTME or robotic TME included many centres where the surgeons were on a learning curve and hence the true oncological outcomes and clinical benefits can not be measured accurately. Method: The inclusion criteria include experienced surgeons defined as minimum of 60 prior procedures with RLAR or TaTME. Successful oncological and clinical outcomes are defined as circumferential resection margin (CRM) ≥1 mm with limited postoperative morbidity (absence of Clavien-Dindo grade III-IV complications within 30 days after surgery). Local and distal recurrence rates with DFS over 3 years will be measured as primary outcome.Data will be collected prospectively and entered in a dedicated database. Discussion: The primary objective of this study is to conduct a multicentre prospective trial to investigate clinical outcomes, in particular disease free survival (DFS) in patients undergoing RLAR and TaTME. The additional goal is to investigate other efficacy measures, complications rates, health economic aspects and patient reported health related quality of life.This paper describes an important trial conducted in expert centres to establish the needed knowledge for a detailed comparison of outcomes for TaTME versus RLAR.This trial is the first comparative study, comparing TaTME and RLAR, seeking to establish foothold for tailor-made surgical treatment of low rectal cancer patients. Trial registration: The trial is registered in clinicaltrials.gov September 2019. Clinicaltrials.gov id: NCT04200027.

Short-term outcomes in robot-assisted compared to laparoscopic colon cancer resections: a systematic review and meta-analysis.

BACKGROUND: Robot-assisted surgery is increasingly adopted in colorectal surgery. However, evidence for the implementation of robot-assisted surgery for colon cancer is sparse. This study aims to evaluate the short-term outcomes of robot-assisted colon surgery (RCS) for cancer compared to laparoscopic colon surgery (LCS). METHODS: Embase, MEDLINE, and Cochrane Library were searched between January 1, 2005 and October 2, 2020. Randomized clinical trials and observational studies were included. Non-original literature was excluded. Primary endpoints were anastomotic leakage rate, conversion to open surgery, operative time, and length of hospital stay. Secondary endpoints were surgical efficacy and postoperative morbidity. We evaluated risk of bias using RoB2 and ROBINS-I quality assessment tools. We performed a pooled analysis of primary and secondary endpoints. Heterogeneity was assessed by I2, and possible causes were explored by sensitivity- and meta-regression analyses. Publication bias was evaluated by Funnel plots and Eggers linear regression test. The level of evidence was assessed by GRADE. RESULTS: Twenty studies enrolling 13,799 patients (RCS 1740 (12.6%) and LCS 12,059 (87.4%) were included in the meta-analysis that demonstrated RCS was superior regarding: anastomotic leakage (odds ratio (OR) = 0.54, 95% CI [0.32, 0.94]), conversion (OR = 0.31, 95% CI [0.23, 0.41]), overall complication rate (OR = 0.85, 95% CI [0.73, 1.00]) and time to regular diet (MD = - 0.29, 95% CI [- 0.56, 0.02]). LCS proved to have a shortened operative time compared to RCS (MD = 42.99, 95% CI [28.37, 57.60]). Level of evidence was very low according to GRADE. CONCLUSION: RCS showed advantages in colonic cancer surgery regarding surgical efficacy and morbidity compared to LCS despite a predominant inclusion of non-RCT with serious risk of bias assessment and a very low level of evidence.

Systemic inflammatory response in robot-assisted and laparoscopic surgery for colon cancer (SIRIRALS): study protocol of a randomized controlled trial.

BACKGROUND: Robot-assisted surgery is being increasingly adopted in treating colorectal cancer, and the transition from laparoscopic surgery to robot-assisted surgery is a trend. The evidence of the benefits of robot-assisted surgery is sparse. However, findings are associated with improved patient-related outcomes and overall morbidity rates compared to laparoscopic surgery. This induction is unclear, considering both surgical modalities are characterized as minimally invasive. This study aims to evaluate the systemic and peritoneal inflammatory stress response induced by robot-assisted surgery compared with laparoscopic surgery for elective colon cancer resections in a prospective, randomized controlled clinical trial. METHODS: This study is a single-centre randomized controlled superiority trial with 50 colon cancer participants. The primary endpoint is the level of systemic inflammatory response expressed as serum C-reactive protein (CRP) and interleukin 6 (IL-6) levels between postoperative days one and three. Secondary endpoints include (i) levels of systemic inflammation in serum expressed by a panel of inflammatory and pro-inflammatory cytokines measured during the first three postoperative days, (ii) postoperative surgical and medical complications (30 days) according to Clavien-Dindo classification and Comprehensive Complication Index, (iii) intraoperative blood loss, (iv) conversion rate to open surgery, (v) length of surgery, (vi) operative time, (vii) the number of harvested lymph nodes, and (viii) length of hospital stay. The exploratory endpoints are (i) levels of peritoneal inflammatory response in peritoneal fluid expressed by inflammatory and pro-inflammatory cytokines between postoperative day one and three, (ii) patient-reported health-related quality of recovery-15 (QoR-15), (iii) 30 days mortality rate, (iv) heart rate variability and (v) gene transcript (mRNA) analysis. DISCUSSION: To our knowledge, this is the first clinical randomized controlled trial to clarify the inflammatory stress response induced by robot-assisted or laparoscopic surgery for colon cancer resections. Trial registration This trial is registered at Clinicaltrials.gov (Identifier: NCT04687384) on December, 29, 2020, Regional committee on health research ethics, Region of Southern Denmark (N75709) and Data Protection Agency, Hospital Sønderjylland, University Hospital of Southern Denmark (N20/46179).

Improved perioperative outcomes and reduced inflammatory stress response in malignant robot-assisted colorectal resections: a retrospective cohort study of 298 patients.

BACKGROUND: Robot-assisted surgery is increasingly implemented for the resection of colorectal cancer, although the scientific evidence for adopting this technique is still limited. This study's main objective was to compare short-term complication rates, oncological outcomes, and the inflammatory stress response after colorectal resection for cancer performed laparoscopic or robot-assisted. METHODS: We conducted a retrospective cohort study comparing the robot-assisted approach to laparoscopic surgery for elective malignant colorectal neoplasm. Certified colorectal and da Vinci ® robotic surgeons performed resections at a Danish tertiary colorectal high volume center from May 2017 to March 2019. We analyzed the two surgical groups using uni- and multivariate regression analyses to detect differences in intra- and postoperative clinical outcomes and the inflammatory stress response. RESULTS: Two hundred and ninety-eight patients were enrolled in the study. Significant differences favoring robot-assisted surgery was demonstrated for; length of hospital stay (4 days, interquartile range (4, 5) versus 5 days, interquartile range (4-7), p < 0.001), and intraoperative blood loss (50 mL, interquartile range (20-100) versus 100 mL, interquartile range (50-150), p < 0.001) compared to laparoscopic surgery. The inflammatory stress response was significantly higher after laparoscopic compared to robot-assisted surgery reflected by an increase in C-reactive protein concentration (exponentiated coefficient = 1.23, 95% confidence interval (1.06-1.46), p = 0.008). No differences between the two groups were found concerning mortality, microradical resection rate, conversion to open surgery, and surgical or medical short-term complication rates. CONCLUSION: Robot-assisted surgery is feasible and can be safely implemented for colorectal resections. The robot-assisted approach, when compared to laparoscopic surgery, was associated with improved intra- and postoperative outcomes. Extensive prospective studies are needed to determine the short- and long-term outcomes of robotic surgery for colorectal cancer.

[Jejunal diverticulitis as the cause of acute abdomen].

We present two patients with jejunal diverticulitis. Diverticula in jejunum and ileum are very rare, occurring with an incidence of 0.07-2% in the gastrointestinal tract. They are often associated with unspecific symptoms as intermittent abdominal pain, nausea and diarrhoea. The treatment of mild diverticular disease is intravenous fluids and antibiotics. If there is an occurrence of peritonitis as a complication of jejunal diverticulitis, laparatomy may be indicated. Both of the patients received a conservative treatment with intravenous fluids and antibiotics with good response.

[Perforated acute acalculous cholecystitis caused by hepatitis A].

Acute acalculous cholecystitis is a rare condition associated with a high risk of gangrene, empyema and perforation of the gallbladder. In this case report it is described how hepatitis A infection leads to a fulminant perforated acalculous chole-cystitis, which is described sporadically in the literature. The patient presented in this case report had icterus and highly elevated liver enzymes. Magnetic resonance cholangiopan-crea-tography showed an acalculous gallbladder surrounded by free fluid. Laparoscopic cholecystectomy was performed due to sus-picion of perforated acute acalculous cholecystitis.