Status:
COMPLETED
Robotic-assisted and Laparoscopic Right Colectomy Study - Intracorporeal vs. Extracorporeal Anastomoses
Lead Sponsor:
Intuitive Surgical
Conditions:
Benign Right Colon Disease
Malignant Right Colon Disease
Eligibility:
All Genders
18+ years
Brief 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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 24 2023
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT03312569
Start Date
February 1 2018
End Date
July 24 2023
Last Update
March 12 2024
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California
Irvine, California, United States, 92697
2
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48197
3
Washington University at St. Louis
St Louis, Missouri, United States, 63110
4
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212