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The purpose of this study is to evaluate the safety and oncological feasibility of robot-assisted surgery for mid/low rectal carcinoma compared with laparoscopic surgery.
Laparoscopic surgery as the treatment for colon cancer has been widely recognized. But its use for rectal cancer is still controversial. Previous trials have shown that although the long-term survival outcomes were similar, laparoscopic surgery did not reach the non-inferiority in terms of local tumor radical resection, compared with open surgery. Robotic techniques are considered to improve the quality of surgery with three-dimensional vision, stable camera platform and flexible robotic arms. Meta-analyses have shown that compared with laparoscopic surgery, robotic surgery could improve surgical quality in terms of open conversion, circumferential resection margin, postoperative complications, postoperative recovery, and quality of life, with similar long-term survival. However, these evidences mainly came from retrospective studies and small-scale randomized controlled trials with low quality. There still needs high-quality clinical trials to confirm the advantages of robotic surgery for rectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-assisted surgery | Experimental | Patients undergo robot-assisted resections. |
|
| Laparoscopic surgery | Active Comparator | Patients undergo laparoscopic resections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted resection | Procedure | Arm I: Robot-assisted resection using da vinci system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional recurrence rate | The proportion of patients with any cancer recurrence in the pelvic or perineal area | 3 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Circumferential resection margin positive rate | The proportion of patients with circumferential resection margin ≤ 1 mm from the tumor | 1 week after surgery |
| Postoperative complication rate | The proportion of patients with any complications occurred within 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianmin Xu, Ph.D., M.D. | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100141 | China | ||
| The Southwest Hospital of Army Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40455621 | Derived | Feng Q, Yuan W, Li T, Tang B, Jia B, Zhou Y, Zhang W, Zhao R, Zhang C, Cheng L, Zhang X, Wei Y, Liang F, He G, Xu J; REAL Study Group. Robotic vs Laparoscopic Surgery for Middle and Low Rectal Cancer: The REAL Randomized Clinical Trial. JAMA. 2025 Jul 8;334(2):136-148. doi: 10.1001/jama.2025.8123. | |
| 36087608 | Derived |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D007431 | Intraoperative Complications |
| D011183 | Postoperative Complications |
| D012008 | Recurrence |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Laparoscopic resection | Procedure | Arm II: Traditional laparoscopic resection. |
|
| 30 days after surgery |
| Overall survival time | Time from surgery to death | 3 years after surgery |
| Disease-free survival time | Time from surgery to any recurrence, metastases or death | 3 years after surgery |
| Operative time | Time from making skin incision to suturing the incision during the surgery | Day 1 |
| Rate of conversion to open surgery | The proportion of patients with the use of a laparotomy incision for any part of the TME procedure or lymph nodes dissection during the surgery | Day 1 |
| Estimated blood loss | Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation. | Day 1 |
| Proximal/distal resection margin | The proximal/distal resection margin will be reported as "positive" or "negative" to define whether tumor is radically resected. It will be reported according to the post-operative pathology. Details are based on NCCN and Chinese guidelines for colorectal cancer. | 1 week after surgery |
| Number of retrieved lymph nodes | The number of lymph node found from the surgical specimen | 1 week after surgery |
| Postoperative hospital stay | The postoperative hospital stay is defined as the number of date from the first day after operation to discharge. | 30 days after surgery |
| Self reported bladder function | This section is assessed using a self-rating scale "International prostate symptom score" (IPSS). | At postoperative 3, 6 and 12 months |
| Self reported sexual function for male patients | This section is assessed using a self-rating scale "International Index of Erectile Function" (IIEF-5). | At postoperative 3, 6 and 12 months |
| Self reported sexual function for female patients | This section is assessed using a self-rating scale "Female Sexual Function Index" (FSFI). | At postoperative 3, 6 and 12 months |
| Chongqing |
| Chongqing Municipality |
| 671014 |
| China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| Jilin Cancer Hospital | Changchun | Jilin | 130012 | China |
| Chinese PLA General Hospital of Northern Theatre Command (former Shenyang Military General Hospital) | Shenyang | Liaoning | 123005 | China |
| The 960th Hospital of Chinese PLA Joint Logistic Support Force (former Jinan Military General Hospital) | Jinan | Shandong | 250031 | China |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266003 | China |
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200020 | China |
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| The First Affiliated Hospital of Naval Medical University (Changhai Hospital) | Shanghai | Shanghai Municipality | 200438 | China |
| Feng Q, Yuan W, Li T, Tang B, Jia B, Zhou Y, Zhang W, Zhao R, Zhang C, Cheng L, Zhang X, Liang F, He G, Wei Y, Xu J; REAL Study Group. Robotic versus laparoscopic surgery for middle and low rectal cancer (REAL): short-term outcomes of a multicentre randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Nov;7(11):991-1004. doi: 10.1016/S2468-1253(22)00248-5. Epub 2022 Sep 8. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |