Colonic NeoplasmsNCT04687384
Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer
A study testing Robotic-assisted colectomy and Conventional laparoscopic colectomy in people with Colonic Neoplasms and Colon Cancer, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms, Colon Cancer, Systemic Inflammatory Response Syndrome
- What is being tested?
- Robotic-assisted colectomy and Conventional laparoscopic colectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer (SIRIRALS-trial): a Randomized Controlled Trial
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
- Colonic Neoplasms, Colon Cancer, Systemic Inflammatory Response Syndrome, Inflammation, Robotic Surgical Procedures, Laparoscopy
- Being tested
- Robotic-assisted colectomy, Conventional laparoscopic colectomy
- Keywords
- Systemic inflammatory response, Colonic neoplasm, Robotic assisted surgery, Laparoscopy
- Medical subject headings
- Colonic Neoplasms, Systemic Inflammatory Response Syndrome, Inflammation, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted colectomyProcedure or surgery
Robotic-assisted colectomy performed by usage of da Vinci Xi robotic technology
Conventional laparoscopic colectomyProcedure or surgery
Conventional laparoscopic colectomy
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted surgery | Experimental | Patients undergoing robotic-assisted colectomy for colonic neoplasm Receives: Procedure: Robotic-assisted colectomy |
| Laparoscopy | Active comparator | Patients undergoing conventional laparoscopic colectomy for colonic neoplasm Receives: Procedure: Conventional laparoscopic colectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and postoperative (day 1-3)
Secondary outcomes (11)
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
Measured: Baseline and postoperative (day 1-3)
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
Measured: 30 days
Differences in intraoperative blood loss
Measured in mL
Measured: 1 day
Conversion rate to open surgery
Number of conversions to open surgery
Measured: 1 day
Length of surgery (total anesthesia time)
Measured in minutes
Measured: 1 day
Length of surgery (total surgical time)
Measured in minutes
Measured: 1 day
Lymph node yield
Pathological examination of lymph nodes
Measured: 14 days
Length of hospital stay
Measured in days
Measured: 14 days
Postoperative pain
Measured by VAS-scale
Measured: Baseline and postoperative (day 1-3 and 14)
Time to first flatus
Measured in hours
Measured: Postoperative (day 1-3)
Time to first bowel movement
Measured in hours
Measured: Postoperative (day 1-3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Aug 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Pedja Cuk, MD, Principal investigator, Surgical Department, Hospital of Southern Jutland, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687384
- Sponsor's protocol ID
- 75709
- Status last verified
- Jun 2021
- First submitted
- 27 Nov 2020
- Last updated
- 16 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38445434Cuk 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.
PubMed 34635066
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer (SIRIRALS-trial): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04687384
- Acronym / sponsor ID
- 75709
- Conditions
- Colonic Neoplasms, Colon Cancer, Systemic Inflammatory Response Syndrome, Inflammation, Robotic Surgical Procedures, Laparoscopy
- Keywords
- Systemic inflammatory response, Colonic neoplasm, Robotic assisted surgery, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Region of Southern Denmark
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted surgery | Experimental | Procedure: Robotic-assisted colectomyPatients undergoing robotic-assisted colectomy for colonic neoplasm |
| Laparoscopy | Active comparator | Procedure: Conventional laparoscopic colectomyPatients undergoing conventional laparoscopic colectomy for colonic neoplasm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted colectomyRobotic-assisted colectomy performed by usage of da Vinci Xi robotic technology | Procedure or surgery | Robotic-assisted surgery |
| Conventional laparoscopic colectomyConventional laparoscopic colectomy | Procedure or surgery | Laparoscopy |
Primary outcome
Changes in levels of systemic inflammatory response expressed by CRP and IL-6 in serum between the two groups
Time frame: Baseline and postoperative (day 1-3)
CRP (mg/L), IL-6 (pg/mL)
11 secondary outcomes
Changes in levels of systemic inflammation in serum between the two groups
Time frame: Baseline and postoperative (day 1-3)
Differences in number of patients with postoperative surgical and medical complications (30 days) according to Clavien-Dindo classification and Comprehensive Complication Index (CCI)
Time frame: 30 days
Differences in intraoperative blood loss
Time frame: 1 day
Conversion rate to open surgery
Time frame: 1 day
Length of surgery (total anesthesia time)
Time frame: 1 day
Length of surgery (total surgical time)
Time frame: 1 day
Lymph node yield
Time frame: 14 days
Length of hospital stay
Time frame: 14 days
Postoperative pain
Time frame: Baseline and postoperative (day 1-3 and 14)
Time to first flatus
Time frame: Postoperative (day 1-3)
Time to first bowel movement
Time frame: Postoperative (day 1-3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Derived from this study: PubMed 38445434Cuk 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.
- Derived from this study: PubMed 34635066Cuk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedja Cuk, MD principal investigator
Surgical Department, Hospital of Southern Jutland, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted colectomy and Conventional laparoscopic colectomy in people with Colonic Neoplasms and Colon Cancer, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedja Cuk, MD (+4579970000, pedja.cuk@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in levels of systemic inflammatory response expressed by CRP and IL-6 in serum between the two groups (time frame: Baseline and postoperative (day 1-3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04687384, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.