Robotic-assisted and Laparoscopic Right… | Clinical Trial

Key information

Conditions

Benign Right Colon Disease Malignant Right Colon Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Irvine, California, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Right Colectomy with Intracorporeal Anastomosis

Procedure

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

Procedure

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.

Primary outcomes

Incidence of incisional hernia at one year after index procedure.

Time frame: 1 year

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.

Secondary outcomes

Time to first flatus after index procedure

Time frame: up to 1 week 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.

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

A Multi-Center Prospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy

Acronym: ANCOR

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2023
First posted: Oct 17, 2017
Registry last updated: Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.