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Surgical Stress and Intracorporeal Anastomosis

Intracorporeal Versus Extracorporeal Anastomosis After Laparoscopic Right Colectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03422588
Enrollment
20
Registered
2018-02-05
Start date
2017-01-01
Completion date
2019-12-01
Last updated
2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Right Colectomy

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).

Interventions

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

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

All elective laparoscopic right colectomy for cancer

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
interleukin 1change between time before surgery, 24 hours after surgery, 72 hours after surgery
interleukin 6change between time before surgery, 24 hours after surgery, 72 hours after surgery
tumor necrosis factor alphachange between time before surgery, 24 hours after surgery, 72 hours after surgery
adrenocorticotropic hormonechange between time before surgery, 24 hours after surgery, 72 hours after surgery
cortisolchange between time before surgery, 24 hours after surgery, 72 hours after surgery
insulinchange between time before surgery, 24 hours after surgery, 72 hours after surgery
glucagonchange between time before surgery, 24 hours after surgery, 72 hours after surgery
C-reactive proteinchange between time before surgery, 24 hours after surgery, 72 hours after surgery
growth hormonechange between time before surgery, 24 hours after surgery, 72 hours after surgery
prolactinchange between time before surgery, 24 hours after surgery, 72 hours after surgery
fibrinogenchange between time before surgery, 24 hours after surgery, 72 hours after surgery

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026