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Approximately one third of patients with colorectal cancer are diagnosed as locally advanced stage with metastasis to N3 - N4 lymph nodes requiring a D3 - D4 lymphadenectomy. Our previous study has indicated that, by laparoscopic approach, the extended abdomino-iliac lymphadenectomy, the so-called D3-D4 lymph node dissection, could be performed with quick convalescence and similar oncologic efficacy for the treatment of advanced recto-sigmoid cancer with metastatic lesions over N3-N4 lymph nodes, as compared with traditional open surgery. In the present study, the investigators will further compare the oncologic and functional outcomes of robotic versus laparoscopic approach in performing such challenging surgical procedures for patients with advanced colorectal cancer requiring a D3-D4 lymphadenectomy through a randomized prospective clinical trial.
Approximately one third of patients with colorectal cancer are diagnosed as locally advanced stage with metastasis to N3 - N4 lymph nodes requiring a D3 - D4 lymphadenectomy. Our previous study has indicated that, by laparoscopic approach, the extended abdomino-iliac lymphadenectomy, the so-called D3-D4 lymph node dissection, could be performed with quick convalescence and similar oncologic efficacy for the treatment of advanced recto-sigmoid cancer with metastatic lesions over N3-N4 lymph nodes, as compared with traditional open surgery. In the present study, the investigators will further compare the oncologic and functional outcomes of robotic versus laparoscopic approach in performing such challenging surgical procedures for patients with advanced colorectal cancer requiring a D3-D4 lymphadenectomy through a randomized prospective clinical trial.
In the upcoming three years (2020/4/1-2023/3/31),consecutive recto-sigmoid cancer patients with metastasis to para- aortic lymph node will be screened and randomized to patient groups undergoing either robotic or laparoscopic D3-D4 lymph node dissection. The extent of D4 lymph node dissection includes extirpation of the extra-mesenteric lymphatic basin along bilateral common iliac arteries and veins, inferior vena cava, and abdominal aorta upward to the level just below the duodenal third portion and left renal vein, besides the traditional mesenteric dissection of paracolic (N1) lymph nodes, intermediate (N2) mesenteric lymph nodes, and lymph nodes around the root of inferior mesenteric artery (N3). The harvested lymph nodes were mapped and managed according to the Japanese guidelines. The metrics of surgical outcomes included: the number of harvested lymph nodes; time to recurrence of cancer after surgery; the length of operation time; blood loss; intra-operative and post-operative complications; and wound size. Functional recovery was evaluated by length of post-operative flatus passage, the restoration of urinary function, hospitalization, and degree of post-operative pain. A subjective-response standardized questionnaire was given to patients to assess disability, which included the number of days until return to partial activity, full activity, and work.
Since the current randomized prospective study in this field is still lack of, the investigators believe that this study will be of academic importance. And, clinically, the presented study can to help set up the standard operation procedures for such patient, and provide the level one evidence for National Health Insurance Administration in evaluating the reimbursement of HTA (high technology assessment) procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic surgery | No Intervention | The patients will undergoing laparoscopic surgery for the treatment of locally advanced colorectal cancer | |
| Robotic group | Active Comparator | The patients will undergoing robotic surgery for the treatment of locally advanced colorectal cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic surgery | Procedure | The patient group undergoing robotic surgery for the treatment of locally advanced colorectal cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| The time to recurrence of cancer after curative resection | The duration between the time of curative resection and the time to cancer recurrence | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| the number of dissected lymph nodes | The total numbers of lymph node harvested during the operation | An average of 7 days |
| The distribution of dissected lymph nodes | The total numbers of lymph node harvested in different lymph node area during the operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin-Tung LIANG, PhD | Contact | 886-9-72651432 | jintung@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Jin-Tung LIANG, PhD | National Taiwan University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jin-Tung LIANG | Recruiting | Taipei | 886 | Taiwan |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
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Control group: laparoscopic surgery Interventional group: robotic surgery
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No masking
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| An average of 7 days |
| Functional recovery | Functional questionnaire regarding fecal continence and bowel function will be completed by an assistant not aware of the randomization status of the patient right after completion of the manometric studies. Continence was recorded as Grade 1 (perfect continence), Grade 2 (incontinence of flatus), Grade 3 (occasional minor soiling), Grade 4 (frequent major soiling), and Grade 5 (total incontinence). | Up to 6 months |
| The overall costs of both minimally invasive surgical approaches | The total medical costs including medication fee and equipment fee are recorded. | Through patients' discharge from hospital, an average of 7 days |
| Assessment of disability | The time for the patients after the operation to resume partial activity, full activity, and return to work will be recorded to evaluate the disability. | 12 months |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013672 |
| Technology |
| D013676 | Technology, Industry, and Agriculture |