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  • American Society of Clinical Oncology (ASCO)  (2)
  • 1
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 3569-3569
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
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  • 2
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 3_suppl ( 2015-01-20), p. 717-717
    Abstract: 717 Background: A randomized controlled trial to confirm the non-inferiority of laparoscopic surgery to open surgery for clinical stage II/III colon cancers in terms of overall survival was conducted. In this ancillary study, we explored the risk factors for postoperative complications of laparoscopic surgery and open surgery. Methods: Eligibility criteria included colon cancer; tumor located in the cecum, ascending, sigmoid, or rectosigmoid colon; T3 or T4 without involvement of other organs; N0-2; and M0. Postoperative complications which were observed from the end of the operation to discharge were graded according to the CTCAE 3.0. Multivariate analysis was performed using logistic regression model. Results: Between October 2004 and March 2009, a total of 1,057 patients from 30 Japanese centers were registered. By per-protocol set, 524 patients underwent open surgery (OPEN) and 533 patients underwent laparoscopic surgery (LAP). Proportion of any grade (G) complication was 18.3% (OPEN 22.3%, LAP 14.3%), G2–G3 was 12.9% (OPEN 13.9%, LAP 11.8%), G3 was 5.3% (OPEN 6.9%, LAP 3.8%) and G4 was none. Postoperative complications (G2-G3) included leakage (OPEN 2.1%, LAP 1.9%), ileus (OPEN:1.5%, LAP:0.9%), and wound complication (OPEN: 0.2%, LAP: none). Multivariate analysis revealed that risk factors for postoperative complications were operation times 240 min or more (p=0.0019, odds ratio [OR] 2.01 [95% CI: 1.30-3.13] ) and open surgery (p=0.0001, OR 2.05 [95% CI: 1.41-2.98]). Conclusions: Operation times more than 240 min and open surgery were considered to be the risk factors for postoperative complications for clinical stage II/III colon cancers. Clinical trial information: C000000105.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2015
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
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