RESEARCH STUDIES & Clinical Trials

Clinical Trial ID: NCT03312569 A Multi-Center Prospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy

Status

Open

Description

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

Objective

The primary endpoint of the study is the incidence of incisional hernia for intracorporeal and extracorporeal anastomoses within one year after the right colectomy procedure. Incidence of incisional hernia either patient self-reported or clinical diagnosis will be assessed at one year after the right colectomy procedure.

Treatment

Experimental: Intracorporeal Anastomosis Participants will undergo either robotic-assisted or laparoscopic surgery with an intracorporeal anastomosis due to begin or malignant Right Colon Disease. Experimental: Extracorporeal Anastomosis Participants will undergo either robotic-assisted or laparoscopic surgery with an extracorporeal anastomosis due to begin or malignant Right Colon Disease.

Conditions

Other

Phases

I

Therapies

Drugs

Age Group

Adult

Main Investiagtor

Landmann, Ron

Practice

GI

Scope

National

Participating Institutions

Baptist MD Anderson Cancer Center

Eligibility

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

Nct ID Number

NCT03312569

Secondary Trial ID Number

ISI-dVRC-002/ANCOR

Keywords

Observational

More Information

clinicaltrials.gov

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