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Short-term outcomes of laparoscopic intersphincteric resection from a phase II trial to evaluate laparoscopic surgery for stage 0/I rectal cancer: Japan Society of Laparoscopic Colorectal Surgery Lap RC

机译:腹腔镜括约肌间切除术的短期结果,来自于评估0 / I期直肠癌的腹腔镜手术的II期试验:日本腹腔镜结直肠外科协会RC

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Background: Laparoscopic intersphincteric resection (Lap ISR) is not yet an established technique and its safety and feasibility are unclear. Our aim was to clarify the safety and feasibility of Lap ISR for clinical stage 0/I rectal cancer (Lap RC) in a prospective multicenter study of laparoscopic surgery in Japan. Methods: To examine the technical and oncological feasibility of laparoscopic surgery for rectal cancer, we conducted a confirmatory phase II trial to evaluate laparoscopic surgery for preoperative clinical stage 0/I rectal cancer. Eligibility criteria included histologically proven carcinoma, size ≤ 8 cm, age 20-75 years, no bowel obstruction, and no prior chemotherapy or radiotherapy. Between February 2008 and September 2010, 495 patients with rectal cancer underwent laparoscopic surgery at 43 institutions. Patients' background characteristics and operative and postoperative outcomes were recorded prospectively. Results: Seventy-seven patients (15.6 %) underwent Lap ISR. A diverting stoma was created in 69 patients (89.6 %). Conversion to open surgery occurred in 4 patients (5.2 %): 2 patients were converted because of uncontrollable bleeding, and the other 2 patients because of the need for pelvic side wall lymphadenectomy. There was no mortality. Median operative time was 345 min (range = 198-565), median amount of blood loss was 100 ml (range = 0-1760), and three patients (3.9 %) were transfused intraoperatively. The median number of dissected lymph nodes was 14 (range = 3-33), and all (proximal, distal, and vertical) pathological cut margins were negative. Postoperative complications of grade 2 or more were detected in 17 patients (22.1 %), including anastomotic leakage in 5 (6.4 %), bowel obstruction in 5 (6.5 %), and surgical site infection in 2 (2.6 %). Abdominal drainage and diverting stoma were necessary in two patients (2.6 %) due to anastomotic leakage. Median length of postoperative hospital stay was 13 days (range = 7-167). Conclusion: Lap ISR was feasible and safe for clinical stage 0/I rectal cancer with favorable short-term outcome.
机译:背景:腹腔镜括约肌切除术(Lap ISR)尚未确立,其安全性和可行性尚不清楚。我们的目的是在日本的一项腹腔镜手术前瞻性多中心研究中阐明用于临床0 / I期直肠癌(Lap RC)的Lap ISR的安全性和可行性。方法:为了检查腹腔镜手术治疗直肠癌的技术和肿瘤学可行性,我们进行了一项验证性的II期试验,以评估腹腔镜手术对术前0 / I期临床直肠癌的影响。符合条件的标准包括经组织学证实的癌,大小≤8 cm,年龄20-75岁,无肠梗阻,也没有事先化疗或放疗。在2008年2月至2010年9月之间,在43个机构中对495例直肠癌患者进行了腹腔镜手术。前瞻性地记录患者的背景特征以及手术和术后结果。结果:77例患者(15.6%)接受了膝部ISR。 69例患者中产生了转移性气孔(89.6%)。有4例(5.2%)发生了开腹手术转换:2例因无法控制的出血而转换,另2例因需要盆腔侧壁淋巴结清扫术而转换。没有死亡。中位手术时间为345分钟(范围为198-565),中位数失血量为100毫升(范围为0-1760),术中输注了3例患者(3.9%)。解剖的淋巴结的中位数为14(范围= 3-33),所有(近端,远端和垂直)病理切缘均为阴性。在17例患者中发现2级以上的术后并发症(22.1%),包括吻合口漏5例(6.4%),肠梗阻5例(6.5%)和2例手术部位感染(2.6%)。由于吻合口漏,两名患者(2.6%)需要进行腹腔引流和转移造口。术后住院时间中位数为13天(范围= 7-167)。结论:膝部ISR对于0 / I期临床直肠癌是可行且安全的,短期预后良好。

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