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
|Condition or disease||Intervention/treatment|
|Complication of Gastrointestinal Anastomosis Intestinal Anastomosis Complication||Procedure: intracorporeal ileocolic anastomosis Procedure: extracorporeal ileocolic anastomosis|
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]|
|Actual Enrollment :||1225 participants|
|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|
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
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
- 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
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
|Principal Investigator:||Gabriele Anania||Società Italiana Chirurgia Endoscopica|