The Effect of Minimally Invasive Surgery on Systemic Inflammatory Response in Rectal Cancer

• Conditions: Colorectal Cancer; Rectal Cancer; Rectal Cancer Stage; Immune System Disorder; Colorectal Adenocarcinoma
• Interventions: Procedure: rectal cacer surgery

• Registration Number: NCT06540027
• Lead Sponsor: Başakşehir Çam & Sakura City Hospital

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.

Study Timeline

• Study Start: 2024-06-01
• Status Verified: 2024-07
• Study First Submitted: 2024-08-02
• Study First Submitted QC: 2024-08-02
• Study First Posted: 2024-08-06
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2024-12-30
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	rectal cacer surgery	Patients with rectal cancer, open surgery
Study group 2	rectal cacer surgery	Patients with rectal cancer, robotic surgery
Study group 1	rectal cacer surgery	Patients with rectal cancer, laparoscopic surgery

Primary Outcome Measures

Name	Time	Method
immune response	1 day	the level of SII

Trial Locations

Locations (1)

Yigit Duzkoylu; 🇹🇷 Istanbul, Turkey