Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a NHS-PEG Coated Collagen Patch.

Overview

The aim of this study is to analyse the effectiveness and security in the prevention of anastomotic leakage by protecting the ileocolic anastomosis with a reabsorbable NHS-PEG collagen patch.

Full Title of Study: “Prospective Pilot Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a Using a NHS-PEG (N-hydroxysuccinimide Functionalized Polyethylene Glycol) Coated Collagen Patch.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 15, 2019

Interventions

  • Other: NHS-PEG coated collagen patch
    • Analysis of the number and seriousness of leaks in the ileocolic anastomosis after using a NHS-PEG coated collagen patch reinforcement.

Arms, Groups and Cohorts

  • NHS-PEG coated collagen patch cohort
    • Patients diagnosed of colon adenocarcinoma that have ileocolic anastomosis after undergoing a laparoscopic right hemicolectomy surgery.

Clinical Trial Outcome Measures

Primary Measures

  • Effectiveness and security analysis in the prevention of anastomosis leakage through the protection of ileocolic anastomosis with NHS-PEG coated collagen patch.
    • Time Frame: Up to 30 days after the surgery
    • Ileocolic anastomosis leakage existence of evidence and seriousness.

Secondary Measures

  • Analysis of the percentage of leaks in the ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.
    • Time Frame: Up to 30 days after the surgery
    • Percentage of leaks that occur in the ileocolic anastomosis after being reinforced with NHS-PEG coated collagen patch.
  • Number of complications related to anastomotic leakage in patients with ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.
    • Time Frame: Up to 30 days after the surgery
    • Number and type of complications due to the anastomotic leakage in patients with ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.
  • Number of surgical repetitions.
    • Time Frame: Up to 30 days after the surgery
    • Number of following surgeries that the patient has to undergo due to the failure of the collagen patch ileocolic anastomosis protection.
  • Number of hospital readmissions.
    • Time Frame: Up to 30 days after the surgery
    • Number of times that the patient has to be rehospitalized due to the failure of the collagen patch ileocolic anastomosis protection.

Participating in This Clinical Trial

Inclusion Criteria

  • ≥ 18 years old. – Ability to understand and make their own decision to participate in the study. – Pre-surgery right colon adenocarcinoma pathological diagnosis. – Patient with a mechanic, intra or extracorporeal ileocolic anastomosis. Exclusion Criteria:
  • Urgent intervention. – Simultaneous colon cancer. – M1 pre-surgery staging.
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Juan Carlos Gómez Rosado, Principal Investigator, Hospital Universitario Virgen Macarena
    • Overall Contact(s)
      • Juan Carlos Gómez Rosado, 955 00 80 00, juanc.gomez.rosado.sspa@juntadeandalucia.es

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