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

• ClinicalTrials.gov Identifier: NCT03934151
• Recruitment Status: Completed
• First Posted: May 1, 2019
• Last Update Posted: May 1, 2019
• Sponsor: University Hospital of Ferrara
• 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;:.

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

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