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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

306 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2023-07-24

Brief Summary

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

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Detailed Description

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

Conditions

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Benign Right Colon Disease Malignant Right Colon Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Intracorporeal Anastomosis

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

Right Colectomy with Intracorporeal Anastomosis

Intervention Type 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).

Extracorporeal Anastomosis

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

Right Colectomy with Extracorporeal Anastomosis

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No