Robotic-assisted and Laparoscopic Right Colectomy Study - Intracorporeal vs. Extracorporeal Anastomoses (ANCOR)
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|ClinicalTrials.gov Identifier: NCT03312569|
Recruitment Status : Recruiting
First Posted : October 17, 2017
Last Update Posted : July 17, 2018
|Condition or disease||Intervention/treatment|
|Benign Right Colon Disease Malignant Right Colon Disease||Procedure: Intracorporeal Anastomosis Procedure: Extracorporeal Anastomosis|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||A Multi-Center Prospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||November 1, 2018|
|Estimated Study Completion Date :||November 1, 2020|
Participants will undergo either robotic-assisted or laparoscopic surgery with an intracorporeal anastomosis due to begin or malignant Right Colon Disease.
Procedure: 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).
Participants will undergo either robotic-assisted or laparoscopic surgery with an extracorporeal anastomosis due to begin or malignant Right Colon Disease.
Procedure: 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312569
|Contact: Devsmita Das||+1 (408) 523-7596||Devsmita.Das@intusurg.com|
|Contact: Madhu Gorrepati, MD||4085230667||Madhulalitha.Gorrepati@intusurg.com|
|United States, Michigan|
|St. Joseph Mercy Hospital||Recruiting|
|Ann Arbor, Michigan, United States, 48197|
|Contact: Elizabeth Goetz 734-712-8252 firstname.lastname@example.org|
|Principal Investigator: Robert Cleary, MD|
|Sub-Investigator: Amanda McClure, MD|
|Study Director:||Shilpa Mehendale||Intuitive Surgical Inc|