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

NCT06540027 | Enrolling By Invitation

• 1 other identifier: basaksehir2024-37
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Colorectal Adenocarcinoma; Rectal Cancer; Rectal Cancer Stage; Immune System Disorder

Keywords

minimally invasive surgery; robotic surgery; colorectal cancer; immune system response

Outcome Measures

Primary Outcomes (1)

• immune response

  the level of SII

  1 day

Study Arms (3)

Control group

Patients with rectal cancer, open surgery

Procedure: rectal cacer surgery

Study group 1

Patients with rectal cancer, laparoscopic surgery

Procedure: rectal cacer surgery

Study group 2

Patients with rectal cancer, robotic surgery

Procedure: rectal cacer surgery

Interventions

rectal cacer surgery PROCEDURE

minimally invasive surgery

Control group; Study group 1; Study group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients operated with minimally invasive surgery

You may qualify if:

• Patients operated for rectal cancer
• Open surgery
• Laparoscopic surgery
• Robotic surgery

You may not qualify if:

• Patients with diagnosed immune deficiency
• Patients with recurrent colorectal cancer
• Patients with co-existent tumors

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Yigit Duzkoylu

Istanbul, 34480, Turkey (Türkiye)

Location

Related Links

• reference
• reference
• reference
• reference

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms; Immune System Diseases

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Serkan Sari, Prof

  Basaksehir Cith Hospital, Istanbul, Turkey

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: June 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: March 1, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)