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Robotic-assisted and Laparoscopic Right Colectomy Study - Intracorporeal vs. Extracorporeal Anastomoses | Clinical Trials | Clareo Health

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Robotic-assisted and Laparoscopic Right Colectomy Study - Intracorporeal vs. Extracorporeal Anastomoses

A Multi-Center Prospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy

NCT03312569•Intuitive Surgical

View on ClinicalTrials.gov

Summary

To compare intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies

Detailed Description

This is a prospective multicenter observational study to evaluate outcomes of intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject is 18 years or older
•Subject undergoing either laparoscopic or robotic-assisted right colectomy for benign or malignant right colon disease
•Subject undergoing intracorporeal or extracorporeal anastomosis proximal to mid-transverse colon

Exclusion Criteria

•Subject is contraindicated for general anesthesia or surgery
•Emergent Case
•Subject has perforated, obstructing or locally invasive neoplasm (T4b)
•Subject with inflammatory bowel disease
•Subject with prior incisional hernia repair
•Planned right colectomy along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
•Metastatic disease with life expectancy of less than 1 year
•Pregnant or suspect pregnancy
•Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
•Subject belonging to other vulnerable population, e.g, prisoner or ward of the state

Locations (4)

University of California

Irvine, California, United States

St. Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Washington University at St. Louis

St Louis, Missouri, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

February 1, 2018

Primary Completion Date

February 14, 2022

Completion Date

July 24, 2023

Last Updated

March 12, 2024

Enrollment

306

ACTUAL participants

Conditions

Benign Right Colon DiseaseMalignant Right Colon Disease

Interventions

Right Colectomy with Intracorporeal Anastomosis

PROCEDURE

Right Colectomy with Extracorporeal Anastomosis

PROCEDURE