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This pilot study aims to provide valuable insights into the optimal surgical approach for robotic distal gastrectomy. By comparing full robotic procedures with assistant-controlled techniques, the results may guide future practice, enhancing surgical efficiency, reducing costs, and improving patient outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assistant-Controlled Group | Experimental | The assistant performs vascular clipping using articulating Hemolock clip appliers or Challenger® clip appliers and performs the gastrointestinal anastomosis with an Echelon stapling system. |
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| Full Robotic Group | Active Comparator | The surgeon performs vascular clipping using the robotic arm with Hemolock or Hemoclip appliers and performs anastomosis using a SureForm stapler. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm I (Assistant-Controlled Laparoscopic Instrumentation) | Procedure | In this group, robotic distal gastrectomy is performed with assistant-controlled laparoscopic instrumentation. The assistant conducts vascular clipping using articulating Hemolock clip appliers (Livsmed) or Challenger® clip appliers (B.Braun). For gastrointestinal anastomosis, the assistant operates an Echelon stapling system (Johnson & Johnson) via the assistant port. The surgeon controls the robotic console for all other surgical steps. This method utilizes a hybrid approach, combining robotic precision with laparoscopic efficiency. |
| Measure | Description | Time Frame |
|---|---|---|
| Average operative time (in minutes). | The primary outcome is the average operative time (in minutes) from skin incision to skin closure. This measurement will compare surgical efficiency between the assistant-controlled laparoscopic instrumentation group and the full robotic instrumentation group. | At the end of the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total cost of consumable surgical materials. | The total cost of surgical consumables, including robotic instruments, staplers, clips, and other disposable materials used during the procedure, will be calculated from the surgical expense records. | At the end of the surgery (up to 12 hours) |
| Quality of Recovery (QoR-15) scores at 72 hours postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| In Gyu Kwon | Contact | 82-2-2019-4601 | gsirb@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GangnamSeveranceHospital | Recruiting | Seoul | South Korea |
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Single Blind Randomized controlled
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| Arm II (Assistant-Controlled Laparoscopic Instrumentation) | Procedure | In this group, all surgical steps, including vascular clipping and anastomosis, are performed using the robotic system. The surgeon utilizes the Da Vinci Xi system and switches robotic instruments as needed. Vascular clipping is performed with robotic Hemolock or Hemoclip appliers, and anastomosis is conducted using the SureForm robotic stapler. This fully robotic technique eliminates laparoscopic assistance and utilizes only robotic arms for the entire procedure. Both groups follow the same postoperative care protocols, including standardized pain management and recovery assessments. |
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The total cost of surgical consumables, including robotic instruments, staplers, clips, and other disposable materials used during the procedure, will be calculated from the surgical expense records. |
| 72 hours postoperatively |
| Time to first flatus and bowel movement. | The time taken for the patient to pass gas and have a bowel movement will be recorded to assess postoperative gastrointestinal recovery. | Up to 1 month after surgery |
| Postoperative laboratory markers (e.g., CRP, WBC). | Inflammatory markers, including C-reactive protein (CRP) and white blood cell (WBC) counts, will be measured from blood samples to evaluate the patient's inflammatory response. | Up to 5 days after surgery |
| Incidence of postoperative complications. | The incidence of postoperative complications, including infections, bleeding, anastomotic leakage, and other surgical site issues, will be recorded and classified according to the Clavien-Dindo classification. | Within 30 days postoperatively |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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