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| Name | Class |
|---|---|
| Shandong Provincial Hospital | OTHER_GOV |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| The First Affiliated Hospital of Henan University of Science and Technology | OTHER |
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This study is designed to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.
Surgical robots were born in the 1980s and have the advantages of being precise, flexible, less invasive and remotely operable than traditional surgical methods. The single-port robot is a further extension of minimally invasive surgery by placing multiple instruments through a single incision. Most studies have reported on the perioperative outcomes of robotic versus conventional laparoscopic surgery in the treatment of colorectal cancer. However, there are limited data comparing the perioperative outcomes of single-port robotics and multi-port robotics in the treatment of colorectal cancer,especially in rectal cancer surgery. The purpose of this study is to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-Port Robotic Surgery | Experimental | Patients with rectal cancer undergo single-port robotic surgery. |
|
| Multi-Port Robotic Surgery | Active Comparator | Patients with rectal cancer undergo multi-port robotic surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-port robotic surgery | Procedure | In this group, patients will be operated using a single-port surgical robot system. In the single-port configuration, a four-channel trocar shall be used. The surgical tools are steered through the curved access channels in the trocar to enter a patient's abdomen. The surgical procedure followed the principle of total mesorectal excision. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical success rate | Proportion of robotic procedures not converted to laparoscopic or open surgery | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Operative time(minutes) | intraoperative |
| Intraoperative blood loss | Estimated blood loss(milliliters,ml) | intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ren Zhao, MD, PHD | Contact | +8618917762018 | zhaorensurgeon@aliyun.com | |
| Kun Liu, MD | Contact | +8618121263082 | lookiere@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ren Zhao, MD, PHD | Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine | Principal Investigator |
| Leping Li, MD | Shandong Provincial Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Henan University of Science & Technology | Luoyang | Henan | 471003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37526117 | Background | Guo Z, Shi Y, Song Z, Jia W, Wang S, Zhang Y, Ji X, Liu K, Zhang T, Cheng X, Zhao R. Single-incision robotic assisted surgery: a nonrandomized cohort pilot study on a novel surgical platform in colorectal surgery. Int J Surg. 2023 Nov 1;109(11):3417-3429. doi: 10.1097/JS9.0000000000000612. |
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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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| ID | Term |
|---|---|
| C047668 | sperm releasing substance |
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| Multi-port robotic surgery | Procedure | In this group, patients will be operated using a multi-port surgical robot system. Surgical instruments enter the abdominal cavity through 4 separate trocars. The surgical procedure followed the principle of total mesorectal excision. |
|
|
| Incision length | Incision length(centimeters,cm) | intraoperative |
| Total incision length | The sum of all incision lengths(centimeters,cm) | intraoperative |
| Length of stay | The postoperative day when patients complied with the predefined discharge | 1-30 days after surgery |
| Postoperative recovery course | Time to first ambulation, flatus, liquid diet and semi-liquid diet (hours after surgery) | 1-14 days after surgery |
| Early morbidity rate | morbidity rate 30 days after surgery | 30 days after surgery |
| Pain score | postoperative pain is recorded using the visual analog scale (VAS) pain score (0-10 points)tool on postoperative day 1, 2, 3 | 1-3 days after surgery |
| Tumor size | The diameter of tumors(centimeters,cm) | 14 days after surgery |
| Incisal margin | Length of proximal and distal margin (centimeters,cm) | 14 days after surgery |
| Lymph node detection | Lymph nodes harvested(numbers) | 14 days after surgery |
| Cosmetic effect | European Organization for Research and Treatment of Cancer Quality of Life | 1 month, 6 months and 1 year after surgery |
| The quality of life-Colorectal | European Organization for Research and Treatment of Cancer Quality of Life | 1 month, 6 months and 1 year after surgery |
| disease free survival rate | 1-year disease free survival rate | 12 months after surgery |
| Xian Shen, MD |
| First Affiliated Hospital of Wenzhou Medical University |
| Study Director |
| Jingming Zhai, MD | The First Affiliated Hospital of Henan University of Science and Technology | Study Director |
| Shandong Provincial Hospital Affiliated to Shandong First Medical University | Jinan | Shandong | 250021 | China |
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| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 201801 | China |
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| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |