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In this study, the investigators assessed the difference in efficacy and safety among robotic-assisted versus laparoscopic abdominoperineal resection for patients with low rectal cancer.
Patients will be eligible for inclusion if their primary tumors is low rectal cancer.
Eligible patients will be randomly assigned to robotic-assisted (arm A) versus laparoscopic (arm B) abdominoperineal resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic-assisted resection | Experimental | patients with low rectal cancer receiving robotic-assisted abdominoperineal resection. |
|
| Laparoscopic resection | Active Comparator | patients with low rectal cancer receiving laparoscopic abdominoperineal resection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-assisted resection. | Procedure | Robotic-assisted abdominoperineal resection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complications | postoperative complications related to operation | 30 days post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| operative mortality | death occurred 30 days after operation | 30 days post operatively |
| disease-free survival | disease-free survival rate at 3 years after operation |
| Measure | Description | Time Frame |
|---|---|---|
| operative time | Time from cutting the skin to suturing the incision during the surgery, recorded in minute | Day 1 |
| rate of conversion to open surgery | The rate of patients actually receiving open surgery in robotic or laparoscopic surgery groups. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianmin Xu, MD | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36036889 | Derived | Feng Q, Tang W, Zhang Z, Wei Y, Ren L, Chang W, Zhu D, Liang F, He G, Xu J. Robotic versus laparoscopic abdominoperineal resections for low rectal cancer: A single-center randomized controlled trial. J Surg Oncol. 2022 Dec;126(8):1481-1493. doi: 10.1002/jso.27076. Epub 2022 Aug 29. |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Laparoscopic resection | Procedure | Laparoscopic abdominoperineal resection |
|
| 3 years |
| overall survival | overall survival rate at 3 and 5 years after operation | 3 and 5 years |
| locoregional recurrence rate | local recurrence rate at 3 and 5 years after operation | 3 and 5 years |
| 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 |
| circumferential resection margin | The circumferential 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. | 10 days post operatively |
| 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. | 10 days post operatively |
| number of retrieved lymph nodes | It will be reported according to the post-operative pathology. | 10 days post operatively |
| postoperative hospital stay | The postoperative hospital stay is defined as the number of date from the first day after operation to discharge. | 30 days post operatively |
| self reported bladder function | This section is assessed using a self-rating scale "International prostate symptom score" (IPSS) | at postoperative 3, 6 and 1 2 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 1 2 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 1 2 months |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |