Surgical Stress and Intracorporeal Anastomosis

Intracorporeal Versus Extracorporeal Anastomosis After Laparoscopic Right Colectomy

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).

Study Overview

• Status: Completed
• Conditions: Laparoscopic Right Colectomy
• Intervention / Treatment: Procedure: Laparoscopic right colectomy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • University of Naples Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All elective laparoscopic right colectomy for cancer

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intracorporeal; Totally laparoscopic right colectomy with intracorporeal anastomosis	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
ACTIVE_COMPARATOR: Extracorporeal; Laparoscopic assisted right colectomy with extracorporeal anastomosis	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• Milone M, Desiderio A, Velotti N, Manigrasso M, Vertaldi S, Bracale U, D'Ambra M, Servillo G, De Simone G, De Palma FDE, Perruolo G, Raciti GA, Miele C, Beguinot F, De Palma GD. Surgical stress and metabolic response after totally laparoscopic right colectomy. Sci Rep. 2021 May 6;11(1):9652. doi: 10.1038/s41598-021-89183-7.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): December 1, 2019
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: January 30, 2018
• First Posted (ACTUAL): February 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Intrastress-unina

Drug and device information, study documents

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