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This is a small-scale pre-clinical exploratory study to investigate the safety of a novel single-port robotic system for general surgery.
Single-incision laparoscopic surgery is a surgical procedure in which multiple laparoscopic instruments are placed through a single small incision. It has the advantages of less surgical trauma, better cosmetic results and less postoperative pain compared with conventional laparoscopic surgery. However, the technical challenges and difficulties, including loss of triangulation, parallel coaxial effect, difficulty of achieving correct exposure, shared fulcrum, lack of ergonomic favorable position, etc. limited its widespread use. Robot-assisted laparoscopic surgery have significant advantages such as minimally invasive, delicate, and flexible, which can greatly expand the surgeon's surgical capabilities and effectively solve the various problems faced by traditional surgery. Therefore, robotic assisted single-port surgery is attracting increasing attention. This study is to investigate the safety of a novel single-port robotic system for general surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-port Endoscopic Surgical System | Experimental | A novel robotic surgical system that can be configured for multi-port, single-port, or hybrid-port procedures. 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic assisted single-port general surgery | Procedure | Robot assisted single-port rectal resection, colectomy, partial gastrectomy, appendectomy and cholecystectomy via the single-port configuration |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion rate | The proportion of converted to laparotomy, laparoscopic surgery and added ≥ 2 trocars | 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | 201801 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30218263 | Background | Grochola LF, Soll C, Zehnder A, Wyss R, Herzog P, Breitenstein S. Robot-assisted versus laparoscopic single-incision cholecystectomy: results of a randomized controlled trial. Surg Endosc. 2019 May;33(5):1482-1490. doi: 10.1007/s00464-018-6430-7. Epub 2018 Sep 14. | |
| 23052525 | Background | Lim MS, Melich G, Min BS. Robotic single-incision anterior resection for sigmoid colon cancer: access port creation and operative technique. Surg Endosc. 2013 Mar;27(3):1021. doi: 10.1007/s00464-012-2549-0. Epub 2012 Oct 10. |
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| Length of stay | The postoperative day when patients complied with the predefined discharge criteria(days after surgery) | 1-14 days after surgery |
| Early morbidity rate | morbidity rate 30 days after surgery | 30 days after surgery |
| Incision healing | Incision healing grade at discharge. Grade A: well healed; Grade B: incision with inflammatory reaction but no suppuration; Grade C: incision cracked and suppurating | 1-14 days after surgery |
| 37526117 | Derived | 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. |