Clinical trial · Interventional
Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer
Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer (SIRIRALS-trial): a Randomized Controlled Trial
NCT04687384CI-TRIAL-00052311unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
| Inflammation | — | UNRESOLVED | — |
| Laparoscopy | — | UNRESOLVED | — |
| Peritoneal Inflammation | — | UNRESOLVED | — |
| Robotic Surgical Procedures | — | UNRESOLVED | — |
| Systemic Inflammatory Response Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional laparoscopic colectomy | Procedure | — | UNRESOLVED |
| Robotic-assisted colectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robotic-assisted surgery
- description
- Patients undergoing robotic-assisted colectomy for colonic neoplasm
- interventionNames
- Procedure: Robotic-assisted colectomy
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopy
- description
- Patients undergoing conventional laparoscopic colectomy for colonic neoplasm
- interventionNames
- Procedure: Conventional laparoscopic colectomy
Primary outcomes (1)
- measure
- Changes in levels of systemic inflammatory response expressed by CRP and IL-6 in serum between the two groups
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * Elective robotic-assisted or laparoscopic surgery for right-sided, left-sided and sigmoid colon cancer * Aged ≥ 18 * ASA-score ≤ 3 * Tumor-stage (Tx-T4a) * Endoscopic suspected colon cancer * Histological verified adenocarcinoma, signet ring cell carcinoma, undifferentiated cancer, medullary carcinoma, or another malignant tumor type originating from colon * Patients must give informed written consent * Patients must be able to understand Danish language Exclusion criteria * Carcinoma of the transverse colon or synchronous colorectal cancer * Previous history of colon cancer * Previous open major abdominal surgery with exception of open appendectomy and cholecystectomy. * Metastatic disease * Pregnancy * History of psychiatric or addictive disorder that would prevent the patient from participating in the trial * Emergency colon surgery * Co-existing inflammatory bowel disease * Co-existing immunological disease that requiring ingestion of systemic immunomodulatory drugs (DMARD - disease modifying anti-rheumatic drugs), corticosteroids and biologic disease-modifying anti-rheumatic drugs. * Daily consumption of NSAID drugs
References
Publications (2)
- DERIVEDCuk 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. PMID 38445434
- DERIVEDCuk 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. PMID 34635066