Clinical trial NCT03422588: Surgical Stress and Intracorporeal Anastomosis
Official title: Intracorporeal Versus Extracorporeal Anastomosis After Laparoscopic Right Colectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Right Colectomy
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

All elective laparoscopic right colectomy for cancer

Exclusion Criteria:

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

Primary outcomes:
measure: interleukin 1
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: interleukin 6
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: tumor necrosis factor alpha
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: adrenocorticotropic hormone
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: cortisol
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: insulin
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: glucagon
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: C-reactive protein
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: growth hormone
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: prolactin
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: fibrinogen
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
References:
citation: 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.