Short-term clinical outcomes from a randomized controlled trial to evaluate laparoscopic and open surgery for stage II-III colorectal cancer: Japan Clinical Oncology Group study JCOG 0404 (NCT00147134).

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 538-538
Author(s):  
Seiichiro Yamamoto ◽  
Masafumi Inomata ◽  
Seigo Kitano ◽  
Hiroshi Katayama ◽  
Junki Mizusawa ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Laparoscopic Surgery ◽  
Open Surgery ◽  
Controlled Trial ◽  
Short Term ◽  
Primary Analysis ◽  
Eligibility Criteria ◽  
Minimization Method ◽  
Term Survival

538 Background: The benefits of laparoscopic surgery (LAP) in comparison with open surgery (OP) have been suggested; however, the long-term survival after LAP for advanced colorectal cancer (CRC) requiring complete mesocolic excision is still unclear. We conducted a study to confirm the non-inferiority of LAP to OP in terms of overall survival with less frequent post-operative morbidity. The primary analysis is planned in 2014, and short-term outcomes including post-operative complications are presented here. Methods: Only accredited surgeons from 30 Japanese institutions participated. Eligibility criteria included histologically proven CRC; tumor located in the cecum, ascending, sigmoid or rectosigmoid colon; T3 or deeper lesion without involvement of other organs; N0–2 and M0; tumor size =<8 cm; patient age 20-75 years. Patients were randomized preoperatively by the minimization method. Patients with pathological stage III received adjuvant chemotherapy with fluorouracil plus leucovorin. The primary endpoint is overall survival, and the planned sample size was 1050. Results: A total of 1057 patients were randomized (OP: 528, LAP: 529) between October 2004 and March 2009. Patients assigned to LAP had less blood loss than those assigned to OP (median 30 ml vs 85 ml, p<0.001), although LAP lasted 52 minutes longer than OP (p<0.001). Radicality of resection, as assessed by the number of resected lymph nodes, did not differ between the two groups. LAP was associated with earlier recovery of bowel function (p<0.001), and with a shorter hospital stay (p<0.0001) than OP. Morbidity and mortality until discharge did not differ between the two groups, except for fewer wound-related complications in LAP (p=0.007). Conclusions: Short-term clinical benefits of LAP were demonstrated, and laparoscopic surgery for advanced CRC can be performed safely by experienced surgeons. If the non-inferiority of LAP in overall survival is demonstrated in the primary analysis planned in 2014, LAP will be the new standard surgical procedure for CRC.

Short-term clinical outcomes from a randomized controlled trial to evaluate laparoscopic versus open complete mesocolic excision for stage II,III colorectal cancer (CRC): Japan Clinical Oncology Group study JCOG0404 (NCT00147134).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 3569-3569
Author(s):  
Yusuke Nishizawa ◽  
Norio Saito ◽  
Masafumi Inomata ◽  
Tsuyoshi Etoh ◽  
Seigo Kitano ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Controlled Trial ◽  
Standard Procedure ◽  
Complete Mesocolic Excision ◽  
Stage Ii ◽  
Short Term ◽  
Primary Analysis ◽  
Eligibility Criteria ◽  
Term Survival ◽  
Mesocolic Excision

3569 Background: The benefits of laparoscopic surgery (LAP) in comparison with open surgery (OP) have been suggested; however, the long-term survival of LAP for advanced CRC requiring complete mesocolic excision is still unclear. We conducted a study to confirm the non-inferiority of LAP to OP in terms of overall survival (OS)with less frequent post-operative morbidity. Short-term outcomes including post-operative complications are presented here. Methods: Only accredited surgeons from 30 Japanese institutions participated. Eligibility criteria included histologically proven CRC; tumor located in the cecum, ascending, sigmoid or rectosigmoid colon; T3 or deeper lesion without involvement of other organs; N0–2 and M0; tumor size =<8 cm; patient age 20-75 years. Patients were randomized preoperatively.Patients with pathological stage III received adjuvant chemotherapy with fluorouracil plus leucovorin. The primary endpoint is OS. and the planned sample size was 1050. Results: A total of 1057 patients were randomized (OP: 528, LAP: 529) between October 2004 and March 2009. Conversion to OP was needed for 29 (5.4%) patients in LAP arm (technical conversion; 2.3%, indicated conversion; 2.8%, complicated conversion; 0.4%). Patients assigned to LAP had less blood loss compared with those assigned to OP (median 30 ml vs 85 ml, p<0.001), although LAP lasted 52 minutes longer than did OP (p<0.001). Radicality of resection as assessed by number of resected lymph nodes did not differ between two groups. LAP was associated with earlier recovery of bowel function (p<0.001), and with a shorter hospital stay (p<0.001) compared with OP. Morbidity and mortality untill discharge did not differ between two groups, except for less wound-related complications in LAP (p=0.007). Conclusions: Laparoscopic complete mesocolic excision for stage II,III colorectal cancer can be performed safely and short-term clinical benefits was demonstrated. If the non-inferiority of LAP in OS is demonstrated in the primary analysis planned in 2014 , LAP will be the new standard procedure for CRC.

Economic evaluation of laparoscopic surgery for colorectal cancer

2007 ◽  
Vol 23 (4) ◽  
pp. 464-472 ◽  
Author(s):  
Robyn M. de Verteuil ◽  
Rodolfo A. Hernández ◽  
Luke Vale ◽  
Keyword(s):  
Colorectal Cancer ◽  
Systematic Review ◽  
Laparoscopic Surgery ◽  
Cost Effectiveness ◽  
Incremental Cost ◽  
Open Surgery ◽  
Disease Free Survival ◽  
Cost Effective ◽  
Economic Evaluations ◽  
Short Term

Objectives: The aim of this study was to assess the cost-effectiveness of laparoscopic surgery compared with open surgery for the treatment of colorectal cancer.Methods: A Markov model was developed to model cost-effectiveness over 25 years. Data on the clinical effectiveness of laparoscopic and open surgery for colorectal cancer were obtained from a systematic review of the literature. Data on costs came from a systematic review of economic evaluations and from published sources. The outcomes of the model were presented as the incremental cost per life-year gained and using cost-effectiveness acceptability curves to illustrate the likelihood that a treatment was cost-effective at various threshold values for society's willingness to pay for an additional life-year.Results: Laparoscopic surgery was on average £300 more costly and slightly less effective than open surgery and had a 30 percent chance of being cost-effective if society is willing to pay £30,000 for a life-year. One interpretation of the available data suggests equal survival and disease-free survival. Making this assumption, laparoscopic surgery had a greater chance of being considered cost-effective. Presenting the results as incremental cost per quality-adjusted life-year (QALY) made no difference to the results, as utility data were poor. Evidence suggests short-term benefits after laparoscopic repair. This benefit would have to be at least 0.01 of a QALY for laparoscopic surgery to be considered cost-effective.Conclusions: Laparoscopic surgery is likely to be associated with short-term quality of life benefits, similar long-term outcomes, and an additional £300 per patient. A judgment is required as to whether the short-term benefits are worth this extra cost.

A randomized controlled trial to evaluate laparoscopic versus open complete mesocolic excision (CME) for stage II, III colorectal cancer (CRC): First efficacy results from Japan Clinical Oncology Group Study JCOG0404.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 656-656 ◽  
Author(s):  
Masafumi Inomata ◽  
Hiroshi Katayama ◽  
Junki Mizusawa ◽  
Masahiko Watanabe ◽  
Kenichi Sugihara ◽  
...  
Keyword(s):  
Overall Survival ◽  
Controlled Trial ◽  
Complete Mesocolic Excision ◽  
Late Complications ◽  
Stage Ii ◽  
Eligibility Criteria ◽  
Term Survival ◽  
Clinical Benefits ◽  
Mesocolic Excision

656 Background: The benefits of laparoscopic surgery (LAP) compared with open surgery (OP) have been suggested; however, the long-term survival of LAP for advanced CRC requiring CME is still unclear. We conducted a trial to confirm the non-inferiority of LAP to OP in terms of overall survival (OS). Favorable short-term complications and clinical benefits of LAP have already been demonstrated. Overall survival, the primary endpoint, and late post-operative complications are presented here. Methods: Only accredited surgeons from 30 Japanese institutions participated. Eligibility criteria included histologically proven CRC; tumor located in the cecum, ascending, sigmoid or rectosigmoid colon; T3 or deeper lesion without involvement of other organs; N0-2 and M0; tumor size =<8 cm; age 20-75 years. Patients with pathological stage III received adjuvant chemotherapy with fluorouracil plus leucovorin. The planned sample size was 1,050 patients with a power of 80%, a one-sided alpha of 5% and the non-inferiority margin of the hazard ratio (HR) as 1.366. Results: A total of 1,057 patients were randomized (OP 528, LAP 529) between October 2004 and March 2009. Conversion to OP was needed for 29 patients in LAP arm. 5-year OS was 90.4% (95% CI: 87.5-92.6%) in OP, and 91.8% (89.1-93.8%) in LAP. The non-inferiority of laparoscopic CME in OS was not demonstrated (HR: 1.06 [90% CI: 0.79-1.41(>1.366)], p=0.073). 5-year RFS was 79.7% (76.0-82.9) in OP and 79.3% (75.6-82.6) in LAP (HR: 1.07 [95%CI: 0.82-1.38]). Proportion of grade (G) 2-4 late complications was 22.6% (OP 12.5%, LAP 10.1%). Late complications (G2-G4) included constipations (OP 6.0%, LAP 4.4%), diarrhea (OP 2.9%, LAP 2.7%), paralytic ileus (OP 1.2%, LAP 1.7%), and bowel obstruction of small intestine (OP 3.1%, LAP 2.1%). Conclusions: The non-inferiority of laparoscopic CME in OS was not demonstrated for stage II, III CRC. However, since OS of both arms are almost identical and better than expected, laparoscopic CME is acceptable as a treatment option for stage II, III CRC. Clinical trial information: C000000105.

scholarly journals One-Stage Total Laparoscopic Treatment for Colorectal Cancer With Synchronous Metastasis. Is It Safe and Feasible?

2021 ◽  
Vol 8 ◽  
Author(s):  
Giuseppe Sena ◽  
Arcangelo Picciariello ◽  
Fabio Marino ◽  
Marta Goglia ◽  
Aldo Rocca ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Laparoscopic Surgery ◽  
Blood Loss ◽  
Hospital Stay ◽  
Open Surgery ◽  
Disease Free Survival ◽  
Long Term Outcomes ◽  
Short Term ◽  
One Stage

Liver is the main target organ for colorectal cancer (CRC) metastases. It is estimated that ~25% of CRC patients have synchronous metastases at diagnosis, and about 60% of CRC patients will develop metastases during the follow up. Although several teams have performed simultaneous laparoscopic resections (SLR) of liver and colorectal lesions, the feasibility and safety of this approach is still widely debated and few studies on this topic are present in the literature. The purpose of this literature review is to understand the state of the art of SLR and to clarify the potential benefits and limitations of this approach. Several studies have shown that SLR can be performed safely and with short-term outcomes similarly to the separated procedures. Simultaneous laparoscopic colorectal and hepatic resections combine the advantages of one stage surgery with those of laparoscopic surgery. Several reports compared the short-term outcomes of one stage laparoscopic resection with open resections and showed a similar or inferior amount of blood loss, a similar or lower complication rate, and a significant reduction of hospital stay for laparoscopic surgery respect to open surgery but much longer operating times for the laparoscopic technique. Few retrospective studies compared long term outcomes of laparoscopic one stage surgery with the outcomes of open one stage surgery and did not identify any differences about disease free survival and the overall survival. In conclusion, hepatic and colorectal SLR are a safe and effective approach characterized by less intraoperative blood loss, faster recovery of intestinal function, and shorter length of postoperative hospital stay. Moreover, laparoscopic approach is associated to lower rates of surgical complications without significant differences in the long-term outcomes compared to the open surgery.

Long-term survival after laparoscopic versus open resection for colorectal liver metastases.

2019 ◽  
Vol 37 (18_suppl) ◽  
pp. LBA3516-LBA3516 ◽  
Author(s):  
Åsmund Avdem Fretland ◽  
Davit Aghayan ◽  
Bjørn Edwin ◽  
Keyword(s):  
Overall Survival ◽  
Randomized Controlled Trial ◽  
Laparoscopic Surgery ◽  
Liver Metastases ◽  
Open Surgery ◽  
Colorectal Liver Metastases ◽  
Controlled Trial ◽  
Laparoscopic Group ◽  
Randomized Controlled

LBA3516 Background: Despite the recent worldwide dissemination of laparoscopic liver surgery, the long-term oncologic outcomes of laparoscopic and open liver surgery have never been compared in a randomized controlled trial. Methods: OSLO-COMET was a randomized controlled trial recruiting patients from Oslo University Hospital, Oslo, Norway. The primary outcome of the trial was postoperative morbidity within 30 days. Patients with radically resectable liver metastases from colorectal cancer were randomly assigned to undergo laparoscopic or open parenchyma-sparing liver resection. Overall survival was a predefined secondary endpoint for the trial. Survival data for the treatment arms will be compared using a log-rank test and Kaplan-Meier plots. Results: From February 2012 to January 2016 a total of 294 patients were screened and 280 (95%) patients were randomized to laparoscopic (n = 133) or open (n = 147) surgery. The primary endpoint demonstrated a significant reduction in morbidity from 31% in the open group to 19% in the laparoscopic group. Other secondary outcomes demonstrated no difference between the groups, including the rate of R0 resection and the width of resection margins, while laparoscopic surgery was found to be cost-effective. Patients received perioperative chemotherapy following Norwegian guidelines. The final patient was operated on Feb 28, 2016, and a survival analysis was performed on March 14, 2019, with a minimum of 36 months follow-up. By ITT analysis (n = 280), median overall survival (OS) was 80 months (95% CI 52-108) in the laparoscopic surgery group and 81 months (95% CI 42-120) in the open surgery group, p=0.91. By modified ITT, (only patients that had R0/R1 resection), median recurrence free survival (RFS) was 19 months (10-27) in the laparoscopic group and 16 months (11-21) in the open group, p = 0.96. Conclusions: Laparoscopic surgery in patients with colorectal liver metastases was associated with rates of OS and RFS similar to open surgery. Clinical trial information: NCT01516710.

Multicenter Randomized Controlled Trial of Conventional Versus Laparoscopic Surgery for Colorectal Cancer Within an Enhanced Recovery Programme: EnROL

2014 ◽  
Vol 32 (17) ◽  
pp. 1804-1811 ◽  
Author(s):  
Robin H. Kennedy ◽  
E. Anne Francis ◽  
Rose Wharton ◽  
Jane M. Blazeby ◽  
Philip Quirke ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Laparoscopic Surgery ◽  
Hospital Stay ◽  
Open Surgery ◽  
Enhanced Recovery ◽  
Controlled Trial ◽  
Physical Fatigue ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Secondary Outcomes

Purpose Laparoscopic resection and a multimodal approach known as an enhanced recovery program (ERP) have been major changes in colorectal perioperative care that have improved clinical outcomes for colorectal cancer resection. EnROL (Enhanced Recovery Open Versus Laparoscopic) is a multicenter randomized controlled trial examining whether the benefits of laparoscopy still exist when open surgery is optimized within an ERP. Patients and Methods Adults with colorectal cancer suitable for elective resection were randomly assigned at a ratio of 1:1 to laparoscopic or open surgery within an ERP, stratified by center, cancer site (colon v rectum), and age group (< 66 v 66-75 v > 75 years) using minimization. The primary outcome was physical fatigue at 1 month postsurgery. Secondary outcomes included hospital stay, complications, other patient-reported outcomes (PROs), and physical function. Patients and outcome assessors were blinded until 7 days postsurgery or discharge if earlier. Central independent and blinded pathologic assessment of surgical quality was undertaken. Results A total of 204 patients (laparoscopy, n = 103; open surgery, n = 101) were recruited from 12 UK centers from July 2008 to April 2012. One-month physical fatigue scores were similar in both groups (mean: laparoscopy, 12.28; 95% CI, 11.37 to 13.19 v open surgery, 12.05; 95% CI, 11.14 to 12.96; adjusted mean difference, −0.23; 95% CI, −1.52 to 1.07). Median total hospital stay was significantly shorter after laparoscopic surgery (median: laparoscopy, 5; interquartile range [IQR], 4 to 9 v open surgery, 7; IQR, 5 to 11 days; P = .033). There were no differences in other secondary outcomes or in specimen quality after central pathologic review. Conclusion In patients treated by experienced surgeons within an ERP, physical fatigue and other PROs were similar in both groups, but laparoscopic surgery significantly reduced length of hospital stay.

Sign in / Sign up

Export Citation Format

Share Document