Intracorporeal Versus Extracorporeal Anastomosis In Laparoscopic Right Colon Resection

Summary

STUDY DESIGN This study is a prospective, randomized, multi-center study comparing intracorporeal versus extracorporeal anastomosis in performing laparoscopic right colectomy. The study subjects will be randomly assigned to 1. intracorporeal anastomosis (experimental group) 2. extracorporeal anastomosis (control group) with 1:1 manner. After surgery the subjects will be followed up at 1month, after then, every 3 month in total 3 years.

STUDY POPULATION

1\. Screening A detailed review of the medical records will be performed to assess inclusion/exclusion criteria for all subjects who have been diagnosed with right colon tumor (malignant or benign) or benign disease (complicated diverticulitis and so on) that are subject to a right colectomy procedure.

All patients who are eligible, meet the inclusion and none of the exclusion criteria of this study, will be offered enrollment into the study at each site.

RISK ANALYSIS

1. Potential risks All these procedures are in practice today and only surgeons competent in a technique shall be allowed to perform those surgeries. Therefore, there are no anticipated additional risks than would normally be encountered from these surgeries when they are performed for these patients.
2. Potential benefits There may be some benefit due to having closer follow-up in the study.

QUALIFICATION OF PARTICIPATING SURGEONS

1. Surgical procedure

* Laparoscopic surgery: a surgical technique where operations are performed far from their target anatomy location through small incisions normally less than 15mm.
* Extracorporeal anastomosis: the anastomosis is performed by pulling out the bowel through a laparotomy.
* Intracorporeal anastomosis: the anastomosis is performed inside the abdominal cavity with a laparoscopic technique. Specimen extraction will be done through Pfannenstiel incision or similar incision in lower abdomen.
2. Procedure standardization and qualification procedure Participating surgeons should complete the learning curve of the procedure and experience at least 50 laparoscopic right colectomy. They are required to be evaluated by the quality control (QC) committee. They should submit their unedited videos of laparoscopic right colectomy and must be accepted by 2 or more of total 3 QC committee members.

STATISTICAL ANALYSIS Based on attaining a success rate of 85% for the primary endpoint, a total of 106 subjects will be required for each group. Accounting for a 5% loss, a total of 241 subjects will be recruited for this study.

Conditions

• Adenocarcinoma of the Colon

Interventions

PROCEDURE

Intracorporeal anastomosis

In this group, the anastomosis is performed inside the abdominal cavity with a laparoscopic technique. Specimen extraction will be done through Pfannenstiel incision or similar incision in lower abdomen.

PROCEDURE

Extracorporeal anastomosis

In this group, the anastomosis is performed by pulling out the bowel through a laparotomy.

Sponsors & Collaborators

• Yonsei University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-05

Primary Completion

2024-10-31

Completion

2024-10-31

Countries

• South Korea

Study Locations