摘要：這是一個三年期的研究計畫，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。我們先前的國科會計畫（NSC 97-2314-B-002-025-MY3）已經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。然而，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。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。 我們擬在三年的時間內收集 60 位病患，第一年由於機器正在熟悉階段，因此，先行進行 12 例手術，然後，在第二、三年分別進行 24 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三年，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。
Abstract: This is a three-year research project to test the feasibility for the application of da Vinci surgical system in performing total mesorectal excision for the treatment of advanced rectal cancer, in comparison with standard laparoscopic approach using appropriate parameters of functional recovery and oncologic results. Our previous study （ NSC 97-2314-B-002-025-MY3） has proved that standard laparoscopic approach can achieve the goal of personalized therapy for patients with rectal cancer, in which the surgical practice juggles the radical excision of rectal cancer, and minimal intra-operative and post-operative invasiveness for patients. Remarkably, however, robotic surgery devices have currently been beyond investigational devices and are becoming increasingly disseminated in all fields of surgery. The advantage of robotic surgery include embodying a steady surgical field (motion scaling), providing a magnified and three-dimensional view, and allowing surgeon’s wrist action to be reflected in the tips of the instrument, and thus the less surgeon fatigue and potentially better oncologic outcome due to more stable and precise dissection. Several disadvantages with da Vinci system including the lack of haptic feedback, increased operative time, inability to access all four abdominal quadrants, and the need for an assistant, and most important of all, the high cost of acquisition and of maintenance of the platform are still prohibiting factors in widespread use.In this project, we plan to recruit 60 patients (12, 24, 24 patients in the 1st, 2nd and 3rd year respectively) with low rectal cancer requiring a robotic-assisted total mesorectal excision. The surgical outcomes of such patients will be compared with patients receiving standard laparoscopic TME, by which approximately 100 cases were operate on in our institution. The surgical intraoperative or postoperative complications, and clinico-pathological features including the number of harvested lymph nodes, circumferential resection margin, postoperative recovery (flatus passage, oral feeding, and hospitalization) will be prospectively recorded. The minimal invasiveness of patients will be assessed by objective surgical stress-related factors including serum CD4+/CD8+, ESR, CRP, and IL-6. The postoperative genitourinary functional changes will be evaluated by IPSS, IIEF, FSFI scores. The patients will be followed up for at least 3 years after treatment to evaluate the overall survival.Currently, the benefits of robotic-assisted TME for rectal cancer have not been shown to translate into long-term improved oncologic outcome and survival. In addition, studies are needed to assess for potential advantages in quality of life such as reduced risk of sexual and voiding dysfunction. If proven, these advantages could possibly offset the significantly increased cost of healthcare resources in Taiwan. All the above- mentioned issues inspire us to further conduct this 3-year project, with a view to enhancing the academic reputation of Taiwan Colorectal Surgery and the quality care of patients with rectal cancer in Taiwan.
