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

August 13, 2024 updated by: Başakşehir Çam & Sakura City Hospital
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34480
        • Yigit Duzkoylu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 1 day
the level of SII
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Başakşehir Çam & Sakura City Hospital

Investigators

  • Study Chair: Serkan Sari, Prof, Basaksehir Cith Hospital, Istanbul, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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