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This is a phase 2a clinical trial based on the IDEAL framework to evaluate the safety, feasibility and clinical efficacy of single-port robotic transanal total mesorectal excision (SPr-taTME )surgery. For safety, intraoperative adverse events and 30-day morbidity. For efficacy, successful completion of predefined procedural steps without conversion. The transanal surgical platform consists of a single-port robotic system, while the transabdominal approach can be performed laparoscopically or with single-port robotic assistance.
The study assessed the intraoperative adverse events (device-related and/or procedure-related), postoperative complications, perioperative recovery outcomes, surgical specimen quality, and pathological indices of SPr-taTME in the treatment of mid-to-low rectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-port robotic transanal total mesorectal excision | Experimental | Single-port robotic transanal total mesorectal excision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-port robotic transanal total mesorectal excision | Procedure | Rectal resection by transanal TME with single-port robotic surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative adverse events and 30-day postoperative complications | Intraoperative adverse events (device and/or procedure-related). Events were recorded as Preferred Term and classified under System Organ Class as per MedDRA Common Terminology Criteria for Adverse Events (CTCAE) coding guidelines (https://evs.nci.nih.gov/ftp1/CTCAE/About.html). Postoperative complications will refer to any medical occurrence directly attributed to the surgical procedure within the first 30 days. | Intraoperative and postoperative 30 days |
| Conversion rate | Conversion to open or laparotomy surgery due to intraoperative complications , technical difficulties, or inability to successfully complete predefined procedural steps . | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of specimen (as proposed and published by Quirke et al) | Quality of specimen (as proposed and published by Quirke et al) | 7 days after surgery |
| Operative time | Record the total operation time, robotic docking time, transanal TME dissection time, and transabdominal TME dissection time respectively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fan Li, MD | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huichao Zheng | Chongqing | 400042 | China |
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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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| Date of surgery (Day 1) |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |