Surgical Stress and Intracorporeal Anastomosis

Overview

The short-term advantages of minimally invasive colon resection have been well established in several randomized trials. A major factor in the development of morbidity is the surgical stress response with subsequent increased demand on the patient's reserves and immune competence. Although the advantage in term of stress response of laparoscopic surgery over open surgery has been widely reported, little is known about the role of Intracorporeal anastomosis.

In an attempt to evaluate the surgical stress response after totally laparoscopic right colectomy a comparative study has been designed.

Two surgical procedures will be evaluated:

- Totally laparoscopic right colectomy with intracorporeal anastomosis (Experimental group)

- Laparoscopic assisted right colectomy with extracorporeal anastomosis (Control group).

Full Title of Study: “Intracorporeal Versus Extracorporeal Anastomosis After Laparoscopic Right Colectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2019

Interventions

  • Procedure: Laparoscopic right colectomy
    • Laparoscopic right colectomy for colorectal cancer with a standard vascular dissection, performing the anastomosis with a side-to-side mechanical anastomosis fashioned intracorporeally versus extra corporeally

Arms, Groups and Cohorts

  • Experimental: Intracorporeal
    • Totally laparoscopic right colectomy with intracorporeal anastomosis
  • Active Comparator: Extracorporeal
    • Laparoscopic assisted right colectomy with extracorporeal anastomosis

Clinical Trial Outcome Measures

Primary Measures

  • interleukin 1
    • Time Frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
  • interleukin 6
    • Time Frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
  • tumor necrosis factor alpha
    • Time Frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
  • adrenocorticotropic hormone
    • Time Frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
  • cortisol
    • Time Frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
  • insulin
    • Time Frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
  • glucagon
    • Time Frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
  • C-reactive protein
    • Time Frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
  • growth hormone
    • Time Frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
  • prolactin
    • Time Frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
  • fibrinogen
    • Time Frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery

Participating in This Clinical Trial

Inclusion Criteria

All elective laparoscopic right colectomy for cancer

Exclusion Criteria

Urgent procedures Immune depressant therapy Immune depressant disease Post-operative Complications

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Federico II University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marco Milone, Professor of Surgery (MD, PhD) – Federico II University

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