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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03312569
Other study ID # ISI-dVRC-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2018
Est. completion date July 24, 2023

Study information

Verified date March 2024
Source Intuitive Surgical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 306
Est. completion date July 24, 2023
Est. primary completion date February 14, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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

Study Design


Intervention

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).
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.

Locations

Country Name City State
United States St. Joseph Mercy Hospital Ann Arbor Michigan
United States University of California Irvine California
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States Washington University at St. Louis Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of incisional hernia at one year after index procedure. 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. 1 year
Secondary Time to first flatus after index procedure The secondary endpoint of the study is time to first flatus for intracorporeal and extracorporeal anastomoses after the right colectomy procedure. Time to first flatus is defined as days from a right colectomy procedure to first occurrence of flatus during subject's post-operative recovery. up to 1 week after index procedure