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Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy (CoDIG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03934151
Recruitment Status : Completed
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Gabriele Anania, University Hospital of Ferrara

Brief Summary:
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

Condition or disease Intervention/treatment
Complication of Gastrointestinal Anastomosis Intestinal Anastomosis Complication Procedure: intracorporeal ileocolic anastomosis Procedure: extracorporeal ileocolic anastomosis

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1225 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Multicenter National Observational Study on Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : December 15, 2018

Group/Cohort Intervention/treatment
intracorporeal anastomosis
patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with intracorporeal technique
Procedure: intracorporeal ileocolic anastomosis
laparoscopic bowel transection and ileocolic anastomosis performed inside the abdomen with specimen retrieval in plastic bag

extracorporeal anastomosis
patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with extracorporeal technique
Procedure: extracorporeal ileocolic anastomosis
ileocolic anastomosis is carried out by exteriorizing the bowel through a limited laparotomy




Primary Outcome Measures :
  1. Anastomotic complications [ Time Frame: maximum 30 days ]
    number of anastomotic complications after right hemicolectomy when ileocolic anastomosis is performed with intracorporeal or extracorporeal technique

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients affected by malignant or benign pathology of the right colon treated in italian surgical centers accredited by the Ministry of Public Health
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934151


Locations
Show Show 85 study locations
Sponsors and Collaborators
University Hospital of Ferrara
Investigators
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Principal Investigator: Gabriele Anania Società Italiana Chirurgia Endoscopica
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gabriele Anania, Professore Associato, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT03934151    
Other Study ID Numbers: 170595
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: privacy

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gabriele Anania, University Hospital of Ferrara:
laparoscopy
ileocolic anastomosis
right hemicolectomy