A Randomized Trial of Laparoscopic versus Open Surgery for Rectal Cancer

3518 Background: Laparoscopic surgery for rectal cancer has been used widely. However, recent two randomized trials raised concerns about short-term oncologic safety of laparoscopic surgery for rectal cancer. The aim of this study was to evaluate the long-term oncologic safety of laparoscopic surgery for rectal cancer based on 7-year data from the Comparison of Open versus laparoscopic surgery for mid or low REctal cancer After Neoadjuvant chemoradiotherapy (COREAN) trial. Methods: COREAN trial was a non-inferiority, randomized controlled trial. Between April, 2006, and Aug, 2009, eligible participants with mid or low rectal cancer treated with preoperative chemoradiotherapy were randomly assigned (1:1) to laparoscopic (n = 170) or open surgery (n = 170). Seven-year outcomes included overall and disease-free survival, and local recurrence. Log-rank test and stratified Cox regression analysis were used for survival analysis. Analysis was by intention to treat. Results: The median follow-up times were 84 months (IQR: 61.5-97.0). No differences were found between laparoscopic and open surgery group in terms of overall and disease-free survival, and local recurrence (7-year overall survival: 83.2% [laparoscopic] vs 77.3% [open], p = 0.48; 7-year disease-free survival: 71.6% [laparoscopic] vs 64.3% [open], p = 0.20; 7-year local recurrence: 3.3% [laparoscopic] vs 7.9% [open], p = 0.08). Stratified Cox regression analysis adjusted for ypT, ypN and tumor regression grade showed no significant difference between groups in terms of overall and disease-free survival, and local recurrence. The hazard ratios for overall survival, disease-free survival and local recurrence (open vs laparoscopic surgery) were 0.96 (95% CI = 0.58-1.57), 1.03 (95% CI = 0.70-1.53), and 2.28 (95% CI = 0.82-7.16), respectively. Conclusions: The 7-year analysis confirm the long-term oncological safety of laparoscopic surgery for rectal cancer treated with preoperative chemoradiotherapy. The use of laparoscopic surgery does not compromise the long-term survival outcomes in rectal cancer. Clinical trial information: NCT00470951.

To compare laparoscopic versus open surgery for rectal cancer and analyse the results of the multidisciplinary audited project on total mesorectal excision conducted in Spain. The safety and therapeutic efficiency of laparoscopic surgery for rectal cancer are controversial due to the technical difficulties it involves. A deviation from the oncological principles of mesorectal excision would mean a potential increase in local recurrence and shorter survival. This prospective non-randomised multicentre study includes 4,970 patients with rectal cancer. The study compares perioperative, postoperative, anatomicopathological and survival variables. Five hundred and sixty five patients were excluded. Of the remaining 4,405, 3,018 (68.51%) had open surgery (OS) and 1,387 (31.49%) laparoscopic surgery (LS). The rate of anterior resections was higher in the LS group. The rate of intraoperative tumour perforation, number of red blood cell concentrates transfused and length of hospital stay were greater in the OS group, whereas surgical time was longer in the LS group. The incidence of complications was 45.6% in the OS group and 38.3% in the LS group. Involvement of the circumferential and distal margin, as well as unsatisfactory and partially satisfactory quality of the mesorectum, were greater in the OS group. There were no differences for local recurrence and survival rates. According to these results, laparoscopic surgery is the best option for the surgical treatment of rectal cancer, with similar rates of local recurrence and survival, although there are oncological indicators in this study to suggest that these results can be improved with laparoscopic surgery.

Objectives:The necessity of comparing oncologic results with the use of minimally invasive surgery in rectal cancer has arisen. The aim of the present study was to evaluate the treatment approach in rectal cancer and to compare the outcomes of laparoscopic and open surgery.Methods:Patients who underwent surgery for rectal carcinoma between January 2006 and January 2016 in our institution were evaluated. The results were compared between the two groups according to open or laparoscopic surgery. Clinical characteristics, preoperative and postoperative results, pathological examination results, and disease-free survival rates were compared after the surgical procedure.Results:A total of 121 patients were included in the study. Of the patients, 50 underwent open, and 71 underwent laparoscopic surgery. The median follow-up times were 56.75 months in the open surgery group and 55.2 months in the laparoscopic surgery group. Pathological examination revealed similar numbers of lymph nodes in both groups (p>0.05). The duration of hospital stay was statistically significantly lower in the open surgery group than in the laparoscopic group (p<0.05). The rates of disease-free survival were 74% in the open surgery group and 82.5% in the laparoscopic group, and no statistically significant difference was found (p>0.05).Conclusion:There was no significant difference in complication and recurrence between laparoscopic and open surgery for rectal cancer in our study. The duration of hospital stay of patients was statistically significantly lower in the laparoscopic group than in the open surgery group. Laparoscopic or open surgical options could be preferred according to the clinical suitability of the patient, experience of the surgeon, and resources of the center in rectal cancer treatment.

Laparoscopy-assisted versus open surgery for low rectal cancer (LASRE): 3-year survival outcomes of a multicentre, randomised, controlled, non-inferiority trial

This study was conducted to evaluate the safety of laparoscopic radical resection for rectal cancer. A total of 64 cases of rectal cancer patients undergoing radical surgery between January, 1998 and March, 2010 were collected. The patients were divided into the laparoscopic rectal surgery group (LS group, n=31) and the open surgery group (OS group, n=33). Operation time, postoperative recovery, complications and tumor-free survival rate were compared between the two groups. The inclusion criteria were as follows: Standard Karnofsky score >70 prior to surgery, definitive pathological diagnosis and complete clinical data. The exclusion criteria were concomitant tumors affecting survival. With the Dixon operation, the LS group had a longer operation time compared with the OS group (271.2±56.2 vs. 216.0±62.7 min, respectively; P=0.036), and an earlier time of oral intake (3.0±0.9 vs. 4.7±1.0 days, respectively; P=0.000). There were no significant differences between the LS and OS groups in terms of intraoperative blood loss, number of lymph nodes retrieved, duration of postoperative hyperthermia and hospitalization time (P>0.05). With the Miles operation, there were no obvious differences between the LS and OS groups regarding operation time, intraoperative blood loss, number of lymph nodes retrieved, time of oral intake, duration of postoperative hyperthermia and hospitalization time (P>0.05). Furthermore, there were no significant differences between the LS and OS groups with the Dixon or Miles operation in terms of 3-year tumor-free survival rate (P>0.05). Thus, laparoscopic surgery appears to be a safe and feasible option for the treatment of rectal cancer.

The present study aimed to assess the safety and feasibility of laparoscopic extended pelvic surgery for primary or recurrent rectal cancer. The data on 77 patients, who underwent extended pelvic surgery between February 2008 and June 2014, were retrospectively analyzed. The patients were divided, based on their treatment history, into an open surgery (OS) group (n=41) and a laparoscopic surgery (LS) group (n=36). The operative time in the LS group was significantly longer than that in the OS group (766 vs. 561min; p<0.001). In contrast, the LS group was associated with a significantly lower volume of intraoperative blood loss (195 vs. 923ml; p<0.001), fluid balance (5.38 vs. 8.23ml/kg/h; p<0.001) and rate of complications (40.0 vs. 68.3%; p=0.035), and a significantly shorter postoperative hospital stay. The postoperative levels of colloid osmotic pressure and albumin were significantly higher in the LS group. The operative time of the LS group was longer than that of the OS group; however, the LS group experienced less blood loss and fewer complications. Moreover, LS was associated with a reduction in intraoperative infusions and a reduced fluid balance, which maintained homeostasis.

3516 Background: The efficacy of laparoscopic versus open surgery for low rectal cancer has not yet been established. We aimed to evaluate whether laparoscopic surgery is non-inferior to open surgery for low rectal cancer in terms of oncologic outcomes. Methods: LASRE trial (NCT01899547) is a multicenter, noninferiority, randomized controlled trial being conducted in 22 tertiary hospitals across China. Patients with low rectal cancer and without evidence of pelvic lateral lymph nodes or distant metastasis were randomly assigned (2:1) to laparoscopic or open surgery. The primary outcome was 3-year disease-free survival (DFS). Secondary outcomes included pathological outcomes, 30-day postoperative complications, 30-day mortality, overall survival (OS), and quality of life. The target sample size was 1065 patients. The short-term pathological, surgical, and postoperative recovery outcomes, analyzed in a modified intention-to-treat population (mITT). Results: Between November 12, 2013, and June 6, 2018, 1070 patients were randomized into laparoscopic (n = 712) or open surgery (n = 358) groups; 1039 were included in the mITT analysis (685 in laparoscopic and 354 in open group). Seventeen patients (2.5%) in the laparoscopic group required conversion to open surgery. There were no significant between-group differences in the rates of complete mesorectal excision (85.3% vs. 85.8%; p = 0.777), negative circumferential resection margins (98.2% vs. 99.7%; p = 0.085), negative distal resection margins (99.4% vs. 100%; p = 0.362), and numbers of retrieved lymph nodes (13.0 vs. 12.0; p = 0.394). The laparoscopic surgery group exhibited a shorter time to first flatus (40.4 vs. 44.8 hours; p = 0.006), time to first defecation (61.2 vs. 66.3 hours; p = 0.031), duration of analgesic use (45.0 vs. 48.0 hours; p = 0.001), and duration of hospitalization (8.0 vs. 9.0 days; p = 0.008) compared to the open surgery group. The postoperative complication rates were 13.0% and 17.2% in the laparoscopic and open surgery groups, respectively (p = 0.065). There was no incidence of 30-day mortality. Conclusions: In patients with low rectal cancer, laparoscopic surgery performed by experienced surgeons can provide pathological outcomes comparable with those of open surgery in terms of complete mesorectal excision and negative resection margins, rapid postoperative recovery, and fewer postoperative complications. Clinical trial information: NCT01899547.

BackgroundLaparoscopic surgery for rectal cancer is associated with improved postoperative outcomes compared to open surgery; however, economic studies have yielded contradictory results. The aim of this study was to compare the clinical and economic outcomes of laparoscopic versus open surgery for patients with rectal cancer.MethodsPropensity score matching analysis was performed in a retrospective cohort of patients who underwent elective low anterior resection for rectal cancer treatment by laparoscopic and open surgery in a single Brazilian cancer center. Matched covariates included age, gender, body mass index, pTNM stage, American Society of Anesthesiologists score, type of anesthesia, neoadjuvant chemoradiotherapy, and interval between neoadjuvant chemoradiotherapy and index surgery. The clinical and economic outcomes were evaluated. The follow-up period was within 30 days of the index procedure. The clinical outcomes were reoperation, postoperative complications, operative time, length of stay in the intensive care unit, and postoperative hospital stay. For economic outcomes, a cost analysis was used to compare the costs.ResultsInitially, 220 patients were evaluated. After propensity score matching, 100 patients were included in the analysis (50 patients in the open surgery group and 50 patients in the laparoscopic surgery group). There were no differences in patients’ baseline characteristics. Operative time was longer for laparoscopic surgery (247 minutes vs 285 minutes, P=0.006). There were no significant differences in other clinical outcomes. The hospital costs were similar between the two groups (Brazilian reais 21,233.15 vs Brazilian reais 21,529.28, P=0.115), although the intraoperative costs were higher for laparoscopic surgery, mainly owing to the surgical devices and the theater-related costs. The postoperative costs were lower for laparoscopic surgery, owing to lower intensive care unit, ward, and reoperation costs.ConclusionLaparoscopic surgery for rectal cancer is not costlier than open surgery from the health care provider’s perspective, since the intraoperative costs were offset by lower postoperative costs. Open surgery tends to have a longer length of stay.

The safety of laparoscopic surgery for rectal cancer following chemoradiotherapy (CRT) has not been fully established. The aim of our retrospective study was to examine the outcomes and the factors contributing to the difficulty of laparoscopic surgery after CRT. Eighty-seven consecutive rectal cancer patients treated with CRT were analyzed. Clinicopathological factors were compared between laparoscopic surgery (n=57) and open surgery (n=30) groups, and factors that correlated with operation time and blood loss were analyzed in low anterior resection (LAR) cases in the laparoscopic surgery group (n=46). There was less blood loss in the laparoscopic surgery group than in the open surgery group (191 vs. 1,043ml, p=0.0001), and the operation time in the two groups was similar (329 vs. 322min, p=0.8). The rate of conversion from laparoscopic surgery to open surgery was 1.8%. There was no significant difference in the morbidity rate (laparoscopic surgery 22.8% vs. open surgery 33.3%, p=0.3). All circumferential resection margins were clear. Three-year cumulative rates of local recurrence were as follows: laparoscopic surgery: 1.9% vs. open surgery: 8.4% (p=0.4), and distant recurrence was 28.5% in laparoscopic surgery vs. 22.7% in open surgery (p=0.8) and these rates were not significantly different. In laparoscopic LAR cases, a shorter distance of the tumor from the anal verge was associated with a longer operation time. A high computed tomography Hounsfield units value of the mesorectum (CTV) was associated with increased blood loss in the first 23 cases, but not in the other 23 cases. Laparoscopic surgery following CRT was safe and feasible. A shorter anal verge was associated with a longer operation time. Blood loss increased in cases with high CTV, but this can likely be mitigated by experience.

To compare long-term oncologic outcomes between laparoscopic and open surgery for rectal cancer and to identify independent predictors of survival. Few randomized trials comparing laparoscopic and open surgery for rectal cancer have reported long-term survival data. Data from the 3 randomized controlled trials comparing curative laparoscopic (n=136) and open surgery (n=142) for upper, mid, and low rectal cancer conducted at the Prince of Wales Hospital, Hong Kong, between September 1993 and August 2007 were pooled together for this analysis. Survival and disease status were updated to February 2012. Survival was calculated using the Kaplan-Meier method, and independent predictors of survival were determined using the Cox regression analysis. The demographic data of the 2 groups were comparable. The median follow-up time of living patients was 124.5 months in the laparoscopic group and 136.6 months in the open group. At 10 years, there were no significant differences in locoregional recurrence (5.5% vs. 9.3%; P=0.296), cancer-specific survival (82.5% vs. 77.6%; P=0.443), and overall survival (63.0% vs. 61.1%; P=0.505) between the laparoscopic and open groups. There was a trend toward lower recurrence rate at 10 years in the laparoscopic group than in the open group among patients with stage III cancer (P=0.078). The Cox regression analysis showed that stage III cancer, lymphovascular permeation, and blood transfusion, but not the operative approach, were independent predictors of poorer cancer-specific survival. This pooled analysis with a follow-up of more than 10 years confirms the long-term oncologic safety of laparoscopic surgery for rectal cancer.

Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial

The impact of body mass index (BMI) on outcomes after open or laparoscopic surgery for rectal cancer remains unclear. The objective of this retrospective cohort study was to examine the interaction of body mass index and surgical modality (i.e., laparoscopy versus open) with respect to short-term clinical outcomes in patients with rectal cancer. The ACS-NSQIP database (2012-2016) was reviewed for patients undergoing open or laparoscopic surgery for rectal cancer. The primary outcome was 30-day all-cause morbidity. Logistic regression and Cox proportional hazard models were used for analysis. A total of 16,145 patients were grouped into open (N=6759, 42%) and laparoscopic (N =9386, 58%) cohorts. Patients with higher BMI (p<0.001) and those undergoing open surgery (p<0.001) were at increased risk of all-cause morbidity. There was no significant change in the odds ratio of experiencing all-cause morbidity between open and laparoscopic surgery with increasing BMI (p=0.572). Median length of stay was significantly shorter in the laparoscopy group (4 days vs. 6days; p<0.001), at the cost of increased operative time (239min vs. 210 min, p<0.001). The difference in operative time between laparoscopy and open surgery did not increase with rising BMI (i.e., ∆37min vs. ∆39min at BMI 25kg/m2 vs 50kg/m2, respectively, p=0.491). BMI may not be a strong modifier for surgical approach with respect to short-term clinical outcomes in patients with obesity and rectal cancer. Laparoscopic surgery was associated with improved short-term clinical outcomes, without much change in the absolute difference in operative time compared with open surgery, even at higher BMIs.

Open versus laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): 10-year follow-up of an open-label, non-inferiority, randomised controlled trial

This was a retrospective study that evaluated the surgical outcomes of laparoscopic surgery (LS) for rectal cancer, in comparison with a case control series of open surgery (OS), during an 8-year period. Between October 1998 and December 2006, 203 patients with rectal malignancies underwent colectomy; 146 of them had colectomy with the traditional technique (OS), while 57 underwent resection of rectal cancer laparoscopically (LS). The LS group was compared with 60 patients from the OS group (selected from the 146 OS group patients), matched by size, sex, age, anatomical location of the tumor, type, extent of resection, and pathological stage. Data were obtained from patients' medical records. Statistical analysis was performed with the t test and chi-square test. All data are expressed as mean +/- standard error of the mean (SEM). Mean age of the LS group was 63.7+/-12 years versus 69+/-12 years in the OS group. There were more men than women in both the laparoscopic (33 males, 24 females) and OS groups (35 men, 25 women). The mean follow-up period was 38 months and 78 months for LS and OS groups, respectively. The procedure included low anterior resection (43 in LS and 45 in OS), and 13 patients in both groups underwent abdominoperineal resection and 3 transanal resections (2 in OS and 1 in LS). Mean tumor size was 4.2+/-2.12cm in the LS versus 5.2+/-2.02cm in the OS group. Conversion to an open procedure occurred in 4 patients (6.7%), all in the first 20 cases. Postoperative complications developed in 28 patients (11.7%), 13 in the LS group and 15 in the OS group. Median operative time was longer, but median blood loss was significantly lower in the LS group. The length of hospital stay was significantly shorter for the LS group. Laparoscopic surgery is feasible and safe for patients with rectal cancer and provides benefits during the postoperative period without increased morbidity or mortality.

Purpose: The aim of this study was to assess the impact of laparoscopic vs. conventional open surgery for rectal cancer on clinical and oncologic outcome in a multi-modal setting. Methods: In total, 940 patients who underwent conventional open surgery between February 1995 and October 2007, and 311 patients who underwent laparoscopic surgery between December 2006 and May 2011 were enrolled retrospectively. Oncologic outcomes included 3-year overall survival (OS) and disease free survival, factors affecting them, and risk factors for local and systemic recurrence. Results: No difference was found between laparoscopic surgery and conventional open surgery in terms of OS, disease free survival rate at stages I and II, but the 3-year OS for stage III was different between the groups (70.26% for conventional open surgery vs. 90.14% for laparoscopic surgery; P=0.0002). The 3-year disease free survival rate for stage III was 56.59% for conventional open surgery vs. 56.65% for laparoscopic surgery (P=0.6578). The local recurrence rates were 6.81% vs. 8.47% (conventional open surgery vs. laparoscopic surgery; P=0.4960). The systemic recurrence rates were 15.64% vs. 15.71% (conventional open surgery vs. laparoscopic surgery; P=0.9713). Conclusion: Laparoscopic surgery for rectal cancer showed a similar short-term oncologic outcome to conventional open surgery. This suggests that laparoscopic surgery is an acceptable alternative to conventional open surgery for selected patients with rectal cancer.