摘要：這是一個三年期的研究計畫，此為先前已獲國科會補助一年計畫（案號：NSC101-2314-B-002-056-）的延續，目的在比較達文西機器手臂手術系統及標準腹腔鏡手術在為晚期直腸癌病患進行直腸系膜全切除術的腫瘤治療成果，及病患術後恢復情況。我們先前的計畫已經達成目標，共實施 24位達文西手臂輔助下直腸癌切除手術，並且發表論文證明標準腹腔鏡直腸癌手術可以達到人性化醫療的目標，即腹腔鏡微創手術可以兼顧腫瘤廓清和較快恢復功能的治療成果。隨著科技的進步，達文西機器手臂手術系統已經通過試驗期，而在外科各個領域廣泛應用，其可以達到較佳的手術視野，手術切割過程較穩定、精準、且外科醫師體力較不勞頓的好處。由於達文西機器手臂手術系統的手術過程十分精準，因此，也有外科醫師宣稱其有提升直腸癌治療成績的效果。然而，達文西機器手臂手術系統也有其先天的缺陷，例如：機器手臂在腹腔大範圍的運動會受限制，手術過程仍需一個助手，以及費用的昂貴等。然而，達文西機器手臂在直腸癌手術應用由於目前累積的病例數尚少，且腫瘤治療成果也需要較長期的審慎評估，因此我們需要國科會再給予三年的補助。在本計畫中，我們擬驗證達文西機器手臂手術系統在低位直腸癌手術的可行性及腫瘤治療成果分析。在先前的計畫（案號：NSC 101-2314-B-002-056-）中，由於機器正在熟悉階段，因此，已先行進行 24 例手術，接著，擬在未來的三年分別進行 48 例手術。這些成果將與目前我們每年例行性進行的 100例標準腹腔鏡手術的病患做比較。病患在術中或術後的併發症，以及一些臨床病理因子：例如淋巴腺摘取的數目，周邊安全距離是否足夠，術後恢復狀況(排氣時間、開始進食時間、以及住院日數)將請專人紀錄清楚。而病患的微創情況，也將用客觀的實驗室檢查數據：CD4+/CD8+, ESR, CRP,和 IL-6, 來做評估。而術後病患的性功能及排尿功能的保留情況，也要以客觀的 IPSS,IIEF, FSFI 積分表來做評估。所有病患將至少追蹤五年，以得到更客觀的存活分析。目前在世界上，以達文西機器手臂手術系統進行直腸系膜全切除術仍在起步階段，而長期的病患存活分析資料仍付諸闕如。而在達文西機器手臂手術系統下是否性功能及膀胱功能可得到較佳的保留，而使病患的生活品質提高，也尚未有客觀的文獻出現。因此，假如我們能得到補助進行此研究，不但能提高台灣大腸直腸學界的學術地位，另外也能提升對病人的高品質照顧。如果一旦證實達文西機器手臂手術系統有其好處，則可提供給國健局一些建議，是否此種昂貴的手術系統值得引進，因為其昂貴的費用，可能會因病患術後較快恢復，或生活品質提升，而得到很好的投資報酬率。個人以為，低侵襲性手術是將來大腸直腸癌手術的主流，我們發展低侵襲性手術，不應單純只為縮短病患的傷口尺寸、減低疼痛以及較早出院，而應將目標更擴大到提升病患手術品質，達到最佳腫瘤治療成果。
Abstract: This is a three-year research project to test the feasibility for the application of da Vincisurgical system in performing total mesorectal excision for the treatment of advanced rectalcancer, in comparison with standard laparoscopic approach using appropriate parameters offunctional recovery and oncologic results. Our previous study （NSC 101-2314-B-002-056-）has proved that standard laparoscopic approach can achieve the goal of personalized therapyfor patients with rectal cancer, in which the surgical practice juggles the radical excision ofrectal cancer, and minimal intra-operative and post-operative invasiveness for patients.Remarkably, however, robotic surgery devices have currently been beyond investigationaldevices and are becoming increasingly disseminated in all fields of surgery. The advantage ofrobotic surgery include embodying a steady surgical field (motion scaling), providing amagnified and three-dimensional view, and allowing surgeon’s wrist action to be reflected inthe tips of the instrument, and thus the less surgeon fatigue and potentially better oncologicoutcome due to more stable and precise dissection. Several disadvantages with da Vincisystem including the lack of haptic feedback, increased operative time, inability to access allfour abdominal quadrants, and the need for an assistant, and most important of all, the highcost of acquisition and of maintenance of the platform are still prohibiting factors inwidespread use. However, because the case number in our previous study is still insufficientto draw any solid conclusion, we therefore need further 3-year grant support from NationalScience Council.In the present 3-year project, we plan to recruit 48 patients with low rectal cancerrequiring a robotic-assisted total mesorectal excision. In each year the surgical outcomes ofsuch patients will be compared with patients receiving standard laparoscopic TME, by whichapproximately 100 cases were operate on in our institution. The surgical intraoperative orpostoperative complications, and clinico-pathological features including the number ofharvested lymph nodes, circumferential resection margin, postoperative recovery (flatuspassage, oral feeding, and hospitalization) will be prospectively recorded. The minimalinvasiveness of patients will be assessed by objective surgical stress-related factors includingserum CD4+/CD8+, ESR, CRP, and IL-6. The postoperative genitourinary functional changeswill be evaluated by IPSS, IIEF, FSFI scores. The patients will be followed up for at least 5years after treatment to evaluate the overall survival.Currently, the benefits of robotic-assisted TME for rectal cancer have not been shown totranslate into long-term improved oncologic outcome and survival. In addition, studies areneeded to assess for potential advantages in quality of life such as reduced risk of sexual andvoiding dysfunction. If proven, these advantages could possibly offset the significantlyincreased cost of healthcare resources in Taiwan. All the above- mentioned issues inspire usto further conduct this 3-year project, with a view to enhancing the academic reputation ofTaiwan Colorectal Surgery and the quality care of patients with rectal cancer in Taiwan. Thelaparoscopic or robotic approach should be performed with the goal of better operation notjust smaller incisional wound and shorter hospital stay.
