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Trial Title:
The Effect of Minimally Invasive Surgery on Systemic Inflammatory Response in Rectal Cancer
NCT ID:
NCT06540027
Condition:
Colorectal Cancer
Colorectal Adenocarcinoma
Rectal Cancer
Rectal Cancer Stage
Immune System Disorder
Conditions: Official terms:
Colorectal Neoplasms
Rectal Neoplasms
Immune System Diseases
Conditions: Keywords:
minimally invasive surgery
robotic surgery
colorectal cancer
immune system response
Study type:
Observational [Patient Registry]
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
rectal cacer surgery
Description:
minimally invasive surgery
Arm group label:
Control group
Arm group label:
Study group 1
Arm group label:
Study group 2
Summary:
As a hypothesis and shown in many meta-analyses and randomized controlled studies,
minimally invasive surgery causes less surgical trauma and therefore less proinflammatory
response and immunosuppression develop, and postoperative recovery is faster. Although
various prognostic studies on the relationship between gastrointestinal cancer types and
SII (systemic inflammatory index) and the use of minimally invasive surgery have been
published, the high level of this response and the type of surgery in the treatment of
colorectal cancer have not yet been shown to have a direct effect on SII.
Detailed description:
Minimally invasive surgery has been demonstrated to significantly enhance the host immune
response in colorectal cancer. The effect and the SII marker may be reliable indicators
of this enhancement. A retrospective analysis was conducted on the records of patients
who underwent surgery for colorectal cancer at our clinic over a four-year period. The
patients were divided into three groups according to the surgical approach employed: open
surgery, laparoscopic surgery and robotic surgery.
The primary outcome is: A comparison of the open surgery group with those undergoing
minimally invasive surgery (laparoscopic and robotic) revealed lower SII values in the
robotic surgery group than in the laparoscopic surgery group.
The secondary outcome : The SII values were determined as neutrophil/lymphocyte and
platelet/lymphocyte, which had been previously investigated in other studies.
A comparison will be made with the relevant markers. The research team adheres to the
principles set forth in the Declaration of Helsinki and Good Clinical Practice
guidelines. They will conduct the study in an appropriate manner.
No intervention will be made in the follow-up and treatment of patients, in accordance
with the approval of the hospital ethics committee.
The laboratory records typically examined in the postoperative phase will be re-examined
in a retrospective manner. Furthermore, the personal data of the participants will not be
incorporated into the study.
Criteria for eligibility:
Study pop:
Patients operated with minimally invasive surgery
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
Patients operated for rectal cancer
- Open surgery
- Laparoscopic surgery
- Robotic surgery
Exclusion Criteria:
- Patients with diagnosed immune deficiency
- Patients with recurrent colorectal cancer
- Patients with co-existent tumors
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Yigit Duzkoylu
Address:
City:
Istanbul
Zip:
34480
Country:
Turkey
Start date:
June 1, 2024
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Başakşehir Çam & Sakura City Hospital
Agency class:
Other
Source:
Başakşehir Çam & Sakura City Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06540027
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9419130/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9446812/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8629478/
http://www.cirugiaycirujanos.com/frame_esp.php?id=666
