Clinical trial NCT06540027: The Effect of Minimally Invasive Surgery on Systemic Inflammatory Response in Rectal Cancer
Official title: The Effect of Minimally Invasive Surgery on Systemic Inflammatory Response in Rectal Cancer
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Colorectal Cancer
Colorectal Adenocarcinoma
Rectal Cancer
Rectal Cancer Stage
Immune System Disorder
Keywords: minimally invasive surgery
robotic surgery
colorectal cancer
immune system response
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-06
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated with minimally invasive surgery

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 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.

Eligibility 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

Primary outcomes:
measure: immune response
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yigit Duzkoylu
Study officials:
affiliation: Basaksehir Cith Hospital, Istanbul, Turkey
name: Serkan Sari, Prof
role: STUDY_CHAIR
References: