Surgical Stress and Intracorporeal Anastomosis

Study Overview
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Brief Summary
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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).

Official Title
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Intracorporeal Versus Extracorporeal Anastomosis After Laparoscopic Right Colectomy

Conditions
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Laparoscopic Right Colectomy

Intervention / Treatment
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* Procedure: Laparoscopic right colectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All elective laparoscopic right colectomy for cancer Exclusion Criteria: Urgent procedures Immune depressant therapy Immune depressant disease Post-operative Complications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracorporeal<br>Totally laparoscopic right colectomy with intracorporeal anastomosis | Procedure: Laparoscopic right colectomy<br>* 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<br>|
| Active Comparator: Extracorporeal<br>Laparoscopic assisted right colectomy with extracorporeal anastomosis | Procedure: Laparoscopic right colectomy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| 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 | 
| 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 | 
| C-reactive protein |  | 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 | 
| prolactin |  | 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 |