Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540027
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
The Effect of Minimally Invasive Surgery on Systemic Inflammatory Response in Rectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Minimally Invasive Surgery on Systemic Inflammatory Response in Rectal Cancer
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 neutrophillymphocyte and plateletlymphocyte 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
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 neutrophillymphocyte and plateletlymphocyte 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None