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| Name | Class |
|---|---|
| Region of Southern Denmark | OTHER |
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The current hypothesis is that robotic-assisted surgery results in a reduced systemic and peritoneal inflammatory response (SIRS) compared to laparoscopic surgery in the treatment of colon cancer. The purpose is to evaluate differences in the peritoneal and systemic inflammatory response in robot-assisted and laparoscopic surgery of patients undergoing resection for colon cancer in a randomized, blinded controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic-assisted surgery | Experimental | Patients undergoing robotic-assisted colectomy for colonic neoplasm |
|
| Laparoscopy | Active Comparator | Patients undergoing conventional laparoscopic colectomy for colonic neoplasm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-assisted colectomy | Procedure | Robotic-assisted colectomy performed by usage of da Vinci Xi robotic technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in levels of systemic inflammatory response expressed by CRP and IL-6 in serum between the two groups | CRP (mg/L), IL-6 (pg/mL) | Baseline and postoperative (day 1-3) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in levels of systemic inflammation in serum between the two groups | The cytokine levels are expressed by: Eotaxin, Eotaxin-3, GM-CSF, IFN-γ, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-7, IL-8, IL-8 (HA), IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, TARC, TNF-α, TNF-β, VEGF-A and IL-1RA. All cytokines are measured in pg/mL | Baseline and postoperative (day 1-3) |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of peritoneal inflammatory response in peritoneal fluid | Levels of cytokines are expressed by: Eotaxin, Eotaxin-3, GM-CSF, IFN-γ, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, TARC, TNF-α, TNF-β, VEGF-A as well as IL-1RA and CRP. All cytokines are measured in pg/mL, CRP measured in mg/L |
Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pedja Cuk, MD | Contact | +4579970000 | pedja.cuk@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Pedja Cuk, MD | Surgical Department, Hospital of Southern Jutland, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Southern Denmark | Aabenraa | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38445434 | Derived | Cuk P, Tiskus M, Moller S, Lambertsen KL, Backer Mogensen C, Festersen Nielsen M, Helligso P, Gogenur I, Bremholm Ellebaek M. Surgical stress response in robot-assisted versus laparoscopic surgery for colon cancer (SIRIRALS): randomized clinical trial. Br J Surg. 2024 Mar 2;111(3):znae049. doi: 10.1093/bjs/znae049. | |
| 34635066 | Derived |
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| Conventional laparoscopic colectomy | Procedure | Conventional laparoscopic colectomy |
|
| Differences in number of patients with postoperative surgical and medical complications (30 days) according to Clavien-Dindo classification and Comprehensive Complication Index (CCI) | Number of complications obtained from medical records | 30 days |
| Differences in intraoperative blood loss | Measured in mL | 1 day |
| Conversion rate to open surgery | Number of conversions to open surgery | 1 day |
| Length of surgery (total anesthesia time) | Measured in minutes | 1 day |
| Length of surgery (total surgical time) | Measured in minutes | 1 day |
| Lymph node yield | Pathological examination of lymph nodes | 14 days |
| Length of hospital stay | Measured in days | 14 days |
| Postoperative pain | Measured by VAS-scale | Baseline and postoperative (day 1-3 and 14) |
| Time to first flatus | Measured in hours | Postoperative (day 1-3) |
| Time to first bowel movement | Measured in hours | Postoperative (day 1-3) |
| Postoperative (day 1-3) |
| Patient reported health related quality of recovery (QoR-15) | Recovery is measured according to quality of recovery 15 score (QoR-15). The score ranges from 0-150. A high score indicates a good recovery. | Baseline and postoperative (day 1-3 and 14) |
| Mortality | Number of mortality obtained from medical charts | 30 days |
| Heart rate variability | The heart rate will continuously recorded by ECG intra- and postoperatively | Postoperative (day 1-3) |
| Whole blood gene expression profiling | Gene mRNA transcript analysis | Baseline and postoperative (day 1-3) |
| Time to local cancer recurrence or metastatic spread | The two surgical methods will be compared in order to obtain any differences in the local or metastatic cancer recurrence | 3 years postoperatively |
| Cuk P, Pedersen AK, Lambertsen KL, Mogensen CB, Nielsen MF, Helligso P, Gogenur I, Ellebaek MB. Systemic inflammatory response in robot-assisted and laparoscopic surgery for colon cancer (SIRIRALS): study protocol of a randomized controlled trial. BMC Surg. 2021 Oct 11;21(1):363. doi: 10.1186/s12893-021-01355-4. |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010538 | Peritonitis |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D010532 | Peritoneal Diseases |
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