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This is a prospective single center cohort study on effect of a novel robotic surgical system for performance of minimally invasive surgery in multiple specialties. The targeted procedures include Urological, upper and lower GI robotic surgeries and the expected sample size will be 20 patients. The clinical outcomes for assessment include background demographics, operative time, perioperative complications as well as completion rate of procedure, hospital stay and recovery.
This is a prospective single center cohort study on effect of a novel robotic surgical system for performance of minimally invasive surgery in multiple specialties. The targeted procedures include Urological, upper and lower GI robotic surgeries and the expected sample size will be 20 patients. The procedures will be standardized according to previously reported. The diseases for robotic surgical treatment will include prostate carcinoma, colorectal carcinoma, as well as esophageal hiatal diseases and gastric carcinoma. The clinical outcomes for assessment include background demographics, operative time, perioperative complications as well as completion rate of procedure, hospital stay and recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Surgery | Experimental | Prospective single arm study to investigate effect of a novel robotic surgical system on safety, efficacy and outcomes for performance of minimally invasive surgery across urology, upper and lower GI surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K2 Robotic Surgical System | Device | The K2 Robotic Surgical System is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery in the thorax and abdomen. The K2 Robotic Surgical System consists of a Surgeon Console [SGC], a Patient Side Robot [PSR], and a Vision Cart [VCT], and is used with an endoscope, Surgical Instruments [SGI], and Accessories [ACC]. The surgeon views the three-dimensional endoscopic image on a High-Resolution Stereo Viewer (3D Viewer), which provides a view of the abdominal cavity and surgical instrumentation, along with icons and other user interface features. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System | Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System is defined as the need to change to laparoscopic surgery during the procedure. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of perioperative complications | intraoperative complications and all complications occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification | 30 days |
| intraoperative time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philip WY Chiu, MD | Contact | +85291252907 | philipchiu@surgery.cuhk.edu.hk | |
| Man Yee YUNG, RN | Contact | +85235052956 | myyung@surgery.cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Simon SM Ng, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong | Recruiting | Hong Kong | Outside of US & Canada | 00000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40461168 | Derived | Ng CF, Yee CH, Chiu PKF, Tam MHM, Lai FPT. Evaluation of the safety and efficacy of the Sentire Surgical System (C1000) for robot-assisted radical prostatectomy. Hong Kong Med J. 2025 Jun;31(3):192-198. doi: 10.12809/hkmj2412169. Epub 2025 Jun 4. |
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|
Intraoperative Time
| 30 days |
| Blood Loss | Amount of blood loss in mls | 30 days |
| Pain scores on a visual analog scale | Pain score in visual analog scale scoring system (minimum 0 and maxium 10, higher score represents more pain) | 30 days |
| Analgesic requirement | Total dose of analgesic (Pethidine) used | 30 days |
| Length of Hospital Stay | Days after surgery | 30 days |