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Abdominal Drainage vs Postoperative Antibiotico-prophylaxis vs Control in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis for Right Colon Cancer

Primary Purpose

Colon Cancer

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
abdominal drainage
Postoperative antibiotico-prophylaxis
Sponsored by
University of Rome Tor Vergata
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring intracorporeal anastomosis, right hemicoletomy, colon cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Right colon cancer
  • Intracorporeal anastomosis
  • Laparoscopic surgery
  • Elective surgery
  • informed consent signed

Exclusion Criteria:

  • below 18 years old
  • IBD
  • ASA IV
  • T4b
  • Metastatic disease
  • Preoperative steroids
  • Conversion to open surgery
  • Emergency surgery
  • concomitant major operation
  • preoperative infective status
  • benign disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Abdominal drainage

    Postoperative antibiotico-prophylaxis

    Control group

    Arm Description

    19 Fr abdominal drainage placed intraoperatevely in right paracolic gutter

    postoperative antibiotico-prophylaxis with Ceftriaxone 2gr and Metronidazole 1.5gr

    No drainage nor postoperative antibiotico-prophylaxis

    Outcomes

    Primary Outcome Measures

    C-Reactive Proteine
    measured mg/L in I and III POD

    Secondary Outcome Measures

    White blood cell
    measured thousands/mL in I and III POD
    Procalcitonine
    measured ng/ml in III and V POD
    Days of hospitalization
    number of days of hospitalization
    Readmission rate
    rate of hospital readmission
    Mortality rate
    postoperative mortality
    Surgical site infection rate
    postoperative wound infection
    Anastomotic leak rate
    postoperative Ileocolic anastomotic leakage
    Tolerance to liquid diet
    time to clear fluid tolerance
    Tolerance to solid diet
    time to light diet tolerance
    Time to first flatus
    Time to first flatus postoperatively
    Time to first evacuation
    Time to first evacuation postoperatively
    need of abdomen CTscan rate
    need of abdomen CTscan

    Full Information

    First Posted
    July 15, 2021
    Last Updated
    July 25, 2021
    Sponsor
    University of Rome Tor Vergata
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04977882
    Brief Title
    Abdominal Drainage vs Postoperative Antibiotico-prophylaxis vs Control in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis for Right Colon Cancer
    Official Title
    Abdominal Drainage vs Postoperative Antibiotico-prophylaxis vs Control in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis for Right Colon Cancer.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2021 (Anticipated)
    Primary Completion Date
    November 1, 2022 (Anticipated)
    Study Completion Date
    January 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Rome Tor Vergata

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Monocentric pilot prospective randomized study with 3 cohorts: abdominal drainage vs postoperative antibioticoprophylaxis vs none in patients undergoing laparoscopic right hemicolectomy with introcorporeal anastomosis for right colon cancer

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colon Cancer
    Keywords
    intracorporeal anastomosis, right hemicoletomy, colon cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Abdominal drainage
    Arm Type
    Experimental
    Arm Description
    19 Fr abdominal drainage placed intraoperatevely in right paracolic gutter
    Arm Title
    Postoperative antibiotico-prophylaxis
    Arm Type
    Experimental
    Arm Description
    postoperative antibiotico-prophylaxis with Ceftriaxone 2gr and Metronidazole 1.5gr
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    No drainage nor postoperative antibiotico-prophylaxis
    Intervention Type
    Procedure
    Intervention Name(s)
    abdominal drainage
    Intervention Description
    19 Fr abdominal drainage placed intraoperatively in right colic gutter
    Intervention Type
    Drug
    Intervention Name(s)
    Postoperative antibiotico-prophylaxis
    Intervention Description
    Ceftriaxone 2 gr and Metronidazole 1.5 gr per day for 2 days postoperatively
    Primary Outcome Measure Information:
    Title
    C-Reactive Proteine
    Description
    measured mg/L in I and III POD
    Time Frame
    30 days postoperatively
    Secondary Outcome Measure Information:
    Title
    White blood cell
    Description
    measured thousands/mL in I and III POD
    Time Frame
    30 days postoperatively
    Title
    Procalcitonine
    Description
    measured ng/ml in III and V POD
    Time Frame
    30 days postoperatively
    Title
    Days of hospitalization
    Description
    number of days of hospitalization
    Time Frame
    90 days postoperatively
    Title
    Readmission rate
    Description
    rate of hospital readmission
    Time Frame
    90 days postoperatively
    Title
    Mortality rate
    Description
    postoperative mortality
    Time Frame
    90 days postoperatively
    Title
    Surgical site infection rate
    Description
    postoperative wound infection
    Time Frame
    30 days postoperatively
    Title
    Anastomotic leak rate
    Description
    postoperative Ileocolic anastomotic leakage
    Time Frame
    30 days postoperatively
    Title
    Tolerance to liquid diet
    Description
    time to clear fluid tolerance
    Time Frame
    30 days postoperatively
    Title
    Tolerance to solid diet
    Description
    time to light diet tolerance
    Time Frame
    30 days postoperatively
    Title
    Time to first flatus
    Description
    Time to first flatus postoperatively
    Time Frame
    30 days postoperatively
    Title
    Time to first evacuation
    Description
    Time to first evacuation postoperatively
    Time Frame
    30 days postoperatively
    Title
    need of abdomen CTscan rate
    Description
    need of abdomen CTscan
    Time Frame
    30 days postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Right colon cancer Intracorporeal anastomosis Laparoscopic surgery Elective surgery informed consent signed Exclusion Criteria: below 18 years old IBD ASA IV T4b Metastatic disease Preoperative steroids Conversion to open surgery Emergency surgery concomitant major operation preoperative infective status benign disease

    12. IPD Sharing Statement

    Learn more about this trial

    Abdominal Drainage vs Postoperative Antibiotico-prophylaxis vs Control in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis for Right Colon Cancer

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