Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy

Overview

The aim of the study is to analyze the postoperative complication rate of intracorporeal versus extracorporeal anastomotic technique in laparoscopic or video assisted right hemicolectomy for malignant and benign neoplasms . The lead center is the General and Thoracic Surgery Department of the University of Ferrara. Prof. Anania is the responsible for the enrollment of patients and the coordination with the collaborating centers in the six month-study

Full Title of Study: “Multicenter National Observational Study on Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 30, 2018

Detailed Description

CoDIG is a cohort, observational, prospective, multi-centric national study about ileo-colic anastomosis performing with EC or IC Technique during right laparoscopic hemicolectomy. The observational period lasts from march 2018 and September 2018. The promoter of the study is "Istituto di Chirurgia Generale 1" of Ferrara University Hospital. 135 Italian Hospitals, accredited by Health Ministry, have been contacted via e-mail and all data was compiled into a web accessible SICE database, 85 Italian clinical centres, with demonstrated experience in colorectal laparoscopic surgery, have joined the study. Every centre was asked not to change its surgical habits concerning the technologies used, the surgical approach, the anastomotic method, the post-operative management. Every patient involved into the study was asked to sign a consent form in order to the Helsinki Declaration.

Interventions

  • Procedure: intracorporeal ileocolic anastomosis
    • laparoscopic bowel transection and ileocolic anastomosis performed inside the abdomen with specimen retrieval in plastic bag
  • Procedure: extracorporeal ileocolic anastomosis
    • ileocolic anastomosis is carried out by exteriorizing the bowel through a limited laparotomy

Arms, Groups and Cohorts

  • intracorporeal anastomosis
    • patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with intracorporeal technique
  • extracorporeal anastomosis
    • patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with extracorporeal technique

Clinical Trial Outcome Measures

Primary Measures

  • Anastomotic complications
    • Time Frame: maximum 30 days
    • number of anastomotic complications after right hemicolectomy when ileocolic anastomosis is performed with intracorporeal or extracorporeal technique
  • Postoperative day of discharge
    • Time Frame: 4 to 30 days
    • the lenght of stay in hospital measured in days after right hemicolectomy with ileocolic anastomosis performed with intracorporeal or extracorporeal technique

Participating in This Clinical Trial

Inclusion Criteria

  • Patients and/or legal guardians exhaustively informed by the investigator, and who have voluntarily provided written informed consent or, when unable to read and/or write, verbal consent put into writing by a third person – Patients who underwent elective laparoscopic or video assisted right hemicolectomy at U.O. General and Thoracic Surgery for malignant or bening pathology. – Patients who had prior chemotherapy and radiotherapy Exclusion Criteria:
  • Patients operated in emergency – Pregnant women – Right laparotomic hemicolectomy – BMI> 35
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • University Hospital of Ferrara
    • Provider of Information About this Clinical Study
      • Principal Investigator: Gabriele Anania, Professore Associato – University Hospital of Ferrara
    • Overall Official(s)
      • Gabriele Anania, Principal Investigator, Società Italiana Chirurgia Endoscopica

    Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

    At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.