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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

Tracking Information
First Submitted Date April 26, 2019
First Posted Date May 1, 2019
Last Update Posted Date May 1, 2019
Actual Study Start Date March 1, 2018
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 30, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy
Official Title Multicenter National Observational Study on Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy
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
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Month
Biospecimen Not Provided
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
Condition
  • Complication of Gastrointestinal Anastomosis
  • Intestinal Anastomosis Complication
Intervention
  • 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
Study Groups/Cohorts
  • intracorporeal anastomosis
    patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with intracorporeal technique
    Intervention: Procedure: intracorporeal ileocolic anastomosis
  • extracorporeal anastomosis
    patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with extracorporeal technique
    Intervention: Procedure: extracorporeal ileocolic anastomosis
Publications * Anania G, Agresta F, Artioli E, Rubino S, Resta G, Vettoretto N, Petz WL, Bergamini C, Arezzo A, Valpiani G, Morotti C, Silecchia G; SICE CoDIG (Colon Dx Italian Group). Laparoscopic right hemicolectomy: the SICE (Società Italiana di Chirurgia Endoscopica e Nuove Tecnologie) network prospective trial on 1225 cases comparing intra corporeal versus extra corporeal ileo-colic side-to-side anastomosis. Surg Endosc. 2020 Nov;34(11):4788-4800. doi: 10.1007/s00464-019-07255-2. Epub 2019 Nov 18. Erratum in: Surg Endosc. 2019 Dec 12;:.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 30, 2019)
1225
Original Actual Enrollment Same as current
Actual Study Completion Date December 15, 2018
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03934151
Other Study ID Numbers 170595
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: privacy
Responsible Party Gabriele Anania, University Hospital of Ferrara
Study Sponsor University Hospital of Ferrara
Collaborators Not Provided
Investigators
Principal Investigator: Gabriele Anania Società Italiana Chirurgia Endoscopica
PRS Account University Hospital of Ferrara
Verification Date February 2019