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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
Sponsor:
Information provided by (Responsible Party):
Intuitive Surgical

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

Condition or disease Intervention/treatment
Benign Right Colon Disease Malignant Right Colon Disease Procedure: Intracorporeal Anastomosis Procedure: Extracorporeal Anastomosis

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

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonic Diseases

Group/Cohort Intervention/treatment
Intracorporeal Anastomosis
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).

Extracorporeal Anastomosis
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subject undergoing either laparoscopic or robotic-assisted right colectomy for benign or malignant right colon disease
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Devsmita Das +1 (408) 523-7596 Devsmita.Das@intusurg.com
Contact: Madhu Gorrepati, MD 4085230667 Madhulalitha.Gorrepati@intusurg.com

Locations
United States, Michigan
St. Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48197
Contact: Elizabeth Goetz    734-712-8252    egoetz@michiganheart.com   
Principal Investigator: Robert Cleary, MD         
Sub-Investigator: Amanda McClure, MD         
Sponsors and Collaborators
Intuitive Surgical
Investigators
Study Director: Shilpa Mehendale Intuitive Surgical Inc

Responsible Party: Intuitive Surgical
ClinicalTrials.gov Identifier: NCT03312569     History of Changes
Other Study ID Numbers: ISI-dVRC-002
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases