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Completed

NCT Number: NCT03422588

Surgical Stress and Intracorporeal Anastomosis

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).

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Key information

Conditions

Laparoscopic Right Colectomy

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Naples Federico II

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All elective laparoscopic right colectomy for cancer

Exclusion criteria

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

Treatment and study plan

Laparoscopic right colectomy

Procedure

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

Primary outcomes

  1. interleukin 1

    Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery

  2. interleukin 6

    Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery

  3. tumor necrosis factor alpha

    Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery

  4. adrenocorticotropic hormone

    Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery

  5. cortisol

    Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery

  6. insulin

    Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery

  7. glucagon

    Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery

  8. C-reactive protein

    Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery

  9. growth hormone

    Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery

  10. prolactin

    Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery

  11. fibrinogen

    Time frame: change between time before surgery, 24 hours after surgery, 72 hours after surgery

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Intracorporeal Versus Extracorporeal Anastomosis After Laparoscopic Right Colectomy

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2018
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.