Print

Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Intracorporeal Anastomosis Participants will undergo either robotic-assisted or laparoscopic surgery with an intracorporeal anastomosis due to begin or malignant Right Colon Disease.
  • Procedure: Right Colectomy with Intracorporeal Anastomosis
    With the patient under general anesthesia, pneumoperitoneum is achieved by a method of choice of the operating surgeon. Port Placement is completed as per the standard of care. Dissection is performed and the ileocolic vessels are identified. The right mesocolon is mobilized and the ileal mesentery is divided. The transverse colon and ileum are then divided with the stapler. Next, attention is turned to constructing the anastomosis. For this purpose, the terminal ileum and the transverse colon stump are brought together. A colotomy and ileostomy is created to form a common channel. The common enterotomy is then closed as per the surgeon's standard of care. The specimen is extracted through an off-midline incision (muscle splitting transverse incision, Pfannenstiel).
Extracorporeal Anastomosis Participants will undergo either robotic-assisted or laparoscopic surgery with an extracorporeal anastomosis due to begin or malignant Right Colon Disease.
  • Procedure: Right Colectomy with Extracorporeal Anastomosis
    With the patient under general anesthesia, pneumoperitoneum is achieved by a method of choice of the operating surgeon. Port Placement is completed as per the standard of care. Dissection is performed and the ileocolic vessels are identified. Intracorporeal devascularization may be performed at the surgeon's discretion. The gastrocolic ligament is taken down and the hepatic flexure is mobilized. After complete mobilization of the right colon, the midline incision is extended to serve as the extraction site. The specimen is delivered through the midline extraction incision and the anastomosis is conducted in a standard open technique. The two cut ends of the bowels are aligned for extracorporeal anastomosis.

More Details

Status
Completed
Sponsor
Intuitive Surgical

Study Contact

Detailed Description

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.