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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Colorectal Cancer; Rectal Cancer; Colorectal Adenocarcinoma; Immune System Disorder; Rectal Cancer Stage
• Intervention / Treatment: Procedure: rectal cacer surgery

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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34480
    • Yigit Duzkoylu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients operated with minimally invasive surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; Patients with rectal cancer, open surgery	Procedure: rectal cacer surgery; minimally invasive surgery
Study group 1; Patients with rectal cancer, laparoscopic surgery	Procedure: rectal cacer surgery; minimally invasive surgery
Study group 2; Patients with rectal cancer, robotic surgery	Procedure: rectal cacer surgery; minimally invasive surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
immune response	the level of SII	1 day

Collaborators and Investigators

• Sponsor: Başakşehir Çam & Sakura City Hospital
• Investigators: Study Chair: Serkan Sari, Prof, Basaksehir Cith Hospital, Istanbul, Turkey

Publications and helpful links

Helpful Links

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Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: colorectal cancer; minimally invasive surgery; robotic surgery; immune system response
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Immune System Diseases
• Other Study ID Numbers: basaksehir2024-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No