Surgical Stress and Intracorporeal Anastomosis

Laparoscopic Right Colectomy Clinical Trial

Official title:

Intracorporeal Versus Extracorporeal Anastomosis After Laparoscopic Right Colectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03422588
• Other study ID #: Intrastress-unina
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: March 2020
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

All elective laparoscopic right colectomy for cancer

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Laparoscopic Right Colectomy

Intervention

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

Locations

Country	Name	City	State
Italy	University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	interleukin 1		change between time before surgery, 24 hours after surgery, 72 hours after surgery
Primary	interleukin 6		change between time before surgery, 24 hours after surgery, 72 hours after surgery
Primary	tumor necrosis factor alpha		change between time before surgery, 24 hours after surgery, 72 hours after surgery
Primary	adrenocorticotropic hormone		change between time before surgery, 24 hours after surgery, 72 hours after surgery
Primary	cortisol		change between time before surgery, 24 hours after surgery, 72 hours after surgery
Primary	insulin		change between time before surgery, 24 hours after surgery, 72 hours after surgery
Primary	glucagon		change between time before surgery, 24 hours after surgery, 72 hours after surgery
Primary	C-reactive protein		change between time before surgery, 24 hours after surgery, 72 hours after surgery
Primary	growth hormone		change between time before surgery, 24 hours after surgery, 72 hours after surgery
Primary	prolactin		change between time before surgery, 24 hours after surgery, 72 hours after surgery
Primary	fibrinogen		change between time before surgery, 24 hours after surgery, 72 hours after surgery