Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy

Completed

• Conditions: Complication of Gastrointestinal Anastomosis; Intestinal Anastomosis Complication

• Registration Number: NCT03934151
• Lead Sponsor: 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

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 Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-09-30
• Study Completion: 2018-12-15
• Status Verified: 2019-02
• Study First Submitted: 2019-04-26
• Study First Submitted QC: 2019-04-30
• Last Update Submitted: 2019-04-30
• Study First Posted: 2019-05-01
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1225

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative day of discharge	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
Anastomotic complications	maximum 30 days	number of anastomotic complications after right hemicolectomy when ileocolic anastomosis is performed with intracorporeal or extracorporeal technique

Trial Locations

Locations (84)

ULSS5 Polesa - Ospedale di Adria; 🇮🇹 Adria, Italy

San Lazzaro Alba; 🇮🇹 Alba, Italy

Ospedale Civile L. Bonomo; 🇮🇹 Andria, Italy

"U.Parini" di AOsta; 🇮🇹 Aosta, Italy

Ospedale C e G Mazzoni; 🇮🇹 Ascoli Piceno, Italy

Casa di Cura Villa Maria; 🇮🇹 Avellino, Italy

Ospedale di Bassano del Grappa; 🇮🇹 Bassano Del Grappa, Italy

Policlinico San Marco; 🇮🇹 Bergamo, Italy

Ospedale Maggiore di Bologna; 🇮🇹 Bologna, Italy

SS. Pietro e Paolo; 🇮🇹 Borgosesia, Italy

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