Evidence map›Paper›PMID 34635066›Full record

ArticleBMC surgery2021

Systemic inflammatory response in robot-assisted and laparoscopic surgery for colon cancer (SIRIRALS): study protocol of a randomized controlled trial.

Pedja Cuk, Andreas Kristian Pedersen, Kate Lykke Lambertsen, Christian Backer Mogensen, Michael Festersen Nielsen, Per Helligsø, Ismail Gögenur, Mark Bremholm Ellebæk

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04687384 (Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
0.4field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04687384 naunknown statusnot on this map

Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer (SIRIRALS-trial): a Randomized Controlled Trial

TypeinterventionalSponsorUniversity of Southern DenmarkRan2021 to 2022Enrolled50ConditionsColonic Neoplasms, Colon Cancer, Systemic Inflammatory Response Syndrome, InflammationArmsRobotic-assisted colectomy, Conventional laparoscopic colectomy
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Pedja CukSurgical Department, Hospital Sønderjylland, University Hospital of Southern Denmark, Kresten Philipsens vej 15, 6200, Aabenraa, Denmark. pedja.cuk@rsyd.dk.ORCID http://orcid.org/0000-0003-0582-604X
Andreas Kristian PedersenInstitute of Regional Health Research, University of Southern Denmark, Odense, Denmark.
Kate Lykke LambertsenDepartment of Neurobiology Research, Institute of Molecular Medicine, University of Southern Denmark, Odense, Denmark.
Christian Backer MogensenInstitute of Regional Health Research, University of Southern Denmark, Odense, Denmark.
Michael Festersen NielsenSurgical Department, Hospital Sønderjylland, University Hospital of Southern Denmark, Kresten Philipsens vej 15, 6200, Aabenraa, Denmark.
Per HelligsøSurgical Department, Hospital Sønderjylland, University Hospital of Southern Denmark, Kresten Philipsens vej 15, 6200, Aabenraa, Denmark.
Ismail Gögenur *Surgical Department, Center for Surgical Science, Zealand University Hospital, Roskilde, Denmark.
Mark Bremholm Ellebæk *Surgical Research Unit, Odense University Hospital, Odense, Denmark.
University of Southern Denmark · DKSygehus Sønderjylland · DKZealand University Hospital · DK

Funding

syddansk universitet Funding received from Region of Southern Denmark: J.nr.: 20/44004. I am also affiliated to University of Southern Denmark (ph.d. student)
6 · The paper itself

Abstract

backgroundRobot-assisted surgery is being increasingly adopted in treating colorectal cancer, and the transition from laparoscopic surgery to robot-assisted surgery is a trend. The evidence of the benefits of robot-assisted surgery is sparse. However, findings are associated with improved patient-related outcomes and overall morbidity rates compared to laparoscopic surgery. This induction is unclear, considering both surgical modalities are characterized as minimally invasive. This study aims to evaluate the systemic and peritoneal inflammatory stress response induced by robot-assisted surgery compared with laparoscopic surgery for elective colon cancer resections in a prospective, randomized controlled clinical trial.

methodsThis study is a single-centre randomized controlled superiority trial with 50 colon cancer participants. The primary endpoint is the level of systemic inflammatory response expressed as serum C-reactive protein (CRP) and interleukin 6 (IL-6) levels between postoperative days one and three. Secondary endpoints include (i) levels of systemic inflammation in serum expressed by a panel of inflammatory and pro-inflammatory cytokines measured during the first three postoperative days, (ii) postoperative surgical and medical complications (30 days) according to Clavien-Dindo classification and Comprehensive Complication Index, (iii) intraoperative blood loss, (iv) conversion rate to open surgery, (v) length of surgery, (vi) operative time, (vii) the number of harvested lymph nodes, and (viii) length of hospital stay. The exploratory endpoints are (i) levels of peritoneal inflammatory response in peritoneal fluid expressed by inflammatory and pro-inflammatory cytokines between postoperative day one and three, (ii) patient-reported health-related quality of recovery-15 (QoR-15), (iii) 30 days mortality rate, (iv) heart rate variability and (v) gene transcript (mRNA) analysis. DISCUSSION: To our knowledge, this is the first clinical randomized controlled trial to clarify the inflammatory stress response induced by robot-assisted or laparoscopic surgery for colon cancer resections. Trial registration This trial is registered at Clinicaltrials.gov (Identifier: NCT04687384) on December, 29, 2020, Regional committee on health research ethics, Region of Southern Denmark (N75709) and Data Protection Agency, Hospital Sønderjylland, University Hospital of Southern Denmark (N20/46179).

Indexed as

Colonic NeoplasmsLaparoscopyRoboticsEquivalence Trials as TopicHumansProspective StudiesRandomized Controlled Trials as TopicSystemic Inflammatory Response SyndromeColon cancerInflammatory surgical stress responseLaparoscopic surgeryMinimally invasive surgeryRobot-assisted surgery

Identifiers

PMID34635066
PMCPMC8507379
OpenAlexW3206319688

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.