Intracorporeal vs. Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy for Colonic Cancer (ICEA)

University of Southern Denmark (SDU)

Status: Active, not recruiting

Conditions: Colon Cancer

Treatments: Procedure: Extracorporeal anastomosis; Procedure: Intracorporeal anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT05039762

ICEA-051-2016-NQ

Details and patient eligibility

About

In this study, the investigators will compare extracorporeal anastomosis (EA) with intracorporeal anastomosis (IA) in patients undergoing elective laparoscopic hemicolectomy for right colon cancer.

Full description

At Odense University Hospital, Svendborg, current standard treatment for right colon cancer is laparoscopic hemicolectomy with extracorporeal anastomosis (EA).

To reduce the risk of adverse events, such as fascial dehiscence and later development of incisional hernia, right hemicolectomy with intracorporeal anastomosis has been introduced.

When performing a laparoscopic right hemicolectomy the dissection is carried out intracorporeally and the transection and anastomosis is made extracorporeally (EA technique). For IA technique the cancer bearing segment is resected and the bowel ends joined intracorporeally with laparoscopic technique, and the specimen is then retrieved through a Pfannenstiel incision.

Previous series have shown shorter hospital stay as well as shorter time to bowel recovery in patients treated with IA compared to EA, without increasing the risk of severe complications or compromising the oncological outcome.

The aim of this study is to investigate whether IA in patients undergoing right hemicolectomy reduces the overall complication rate compared to EA evaluated by Comprehensive Complication Index (CCI) .

51 patients will be enrolled in each group.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with right colon cancer
• Eligible for elective laparoscopic right hemicolectomy with primary anastomosis.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• CT staged T1-T3M0 tumour.

Exclusion criteria

• Pregnancy
• Mental incompetence
• Acute right hemicolectomy before the intended elective surgery

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Extracorporeal anastomosis

Active Comparator group

Description:

Laparoscopic right hemicolectomy with Extracorporeal anastomosis in patients with colon cancer.

Treatment:

Procedure: Extracorporeal anastomosis

Intracorporeal anastomosis

Experimental group

Description:

Laparoscopic right hemicolectomy with Intracorporeal anastomosis in patients with colon cancer.

Treatment:

Procedure: Intracorporeal anastomosis