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

Intuitive Surgical

Status: Completed

Conditions: Benign Right Colon Disease; Malignant Right Colon Disease

Treatments: Procedure: Right Colectomy with Intracorporeal Anastomosis; Procedure: Right Colectomy with Extracorporeal Anastomosis

Study type: Observational

Funder types: Industry

Identifiers

NCT03312569

ISI-dVRC-002

Details and patient eligibility

About

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

Full description

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

Enrollment: 306 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

306 participants in 2 patient groups

Intracorporeal Anastomosis

Description:

Participants will undergo either robotic-assisted or laparoscopic surgery with an intracorporeal anastomosis due to begin or malignant Right Colon Disease.

Treatment:

Procedure: Right Colectomy with Intracorporeal Anastomosis

Extracorporeal Anastomosis

Description:

Participants will undergo either robotic-assisted or laparoscopic surgery with an extracorporeal anastomosis due to begin or malignant Right Colon Disease.

Treatment:

Procedure: Right Colectomy with Extracorporeal Anastomosis