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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 : June 18, 2019
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.

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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 : December 31, 2019
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
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Contact: Miriam Rubelt +1 (408) 523-0588 miriam.rubelt@intusurg.com
Contact: Madhu Gorrepati, MD 4085230667 Madhulalitha.Gorrepati@intusurg.com

Locations
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United States, Alabama
The University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
Contact: Amandiy Liwo       amandiyliwo@uabmc.edu   
Principal Investigator: Jamie A Cannon, MD         
Sub-Investigator: Gregory D Kennedy, MD         
Sub-Investigator: Daniel I Chu, MD         
Sub-Investigator: Melanie Morris, MD         
United States, Arizona
Dignity Health - St. Joseph's Hospital Recruiting
Phoenix, Arizona, United States, 85013
Contact: Jessie Burton    602-406-0260      
Principal Investigator: Sushil Pandey, MD         
Scottsdale Healthcare Hospitals Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Shani Hillard       Shani.Hilliard@honorhealth.com   
Principal Investigator: Andrew Kassir, MD         
United States, California
University of California Recruiting
Irvine, California, United States, 92697
Contact: Carlos Chavez    714-456-5396    chavezc@uci.edu   
Principal Investigator: Alessio Pigazzi, MD         
Sub-Investigator: Joseph Carmichael, MD         
Sub-Investigator: Mehraneh D Jafari, MD         
Sub-Investigator: Steven Mills, MD         
United States, District of Columbia
The George Washington University Hospital Recruiting
Washington, District of Columbia, United States, 20037
Contact: Cathy Garey       cgarey@mfa.gwu.edu   
Principal Investigator: Vincent Obias, MD         
United States, Florida
Baptist MD Anderson Cancer Center Recruiting
Jacksonville, Florida, United States, 32207
Contact: Cathy Gonzales    904-202-7319    cathy.gonzales@bmcjax.com   
Principal Investigator: Ron Landmann, MD         
Jackson South Community Hospital Not yet recruiting
Miami, Florida, United States, 33136
Contact: William Steinhardt       wsteinhardt@gmail.com   
Principal Investigator: Henry J Lujan, MD         
Sub-Investigator: Gustavo Plasencia, MD         
Sub-Investigator: Manuel Viamonte III, MD         
United States, Indiana
Franciscan Health Indianapolis Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Melissa Ade    317-834-3603    Melissa.Ade@franciscanalliance.org   
Principal Investigator: Tobi Reidy, DO         
Sub-Investigator: Ben Tsai, MD         
Sub-Investigator: Dipen Maun, MD         
Sub-Investigator: Frederick Lane, MD         
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         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Sara Eischen    612-626-2498    bengt008@umn.edu   
Principal Investigator: Wolfgang B Gaertner, MD         
United States, Missouri
Washington University at St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Michelle Sperry    314-362-2646    sperrym@wustl.edu   
Principal Investigator: Matthew Silviera, MD         
Sub-Investigator: Sean Glasgow, MD         
Sub-Investigator: Steven Hunt, MD         
Sub-Investigator: Matthew Mutch, MD         
Sub-Investigator: Radhika Smith, MD         
Sub-Investigator: Pail Wise, MD         
United States, Nevada
University of Nevada Recruiting
Las Vegas, Nevada, United States, 89154
Contact: Sheila Moore    702-671-6421    Sheila.moore@unlv.edu   
Principal Investigator: Ovunc Bardakcioglu, MD         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Nancy Giebelhaus    518-262-5018    GiebelN@amc.edu   
Principal Investigator: Edward Lee, MD         
Sub-Investigator: Brian T Valerian, MD         
Sub-Investigator: David Chismark, MD         
Sub-Investigator: Jonathan J Canete, MD         
NYU - Lagone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Lisa Zhao       Lisa.zhao@nyulagone.org   
Principal Investigator: Mitchell Bernstein, MD         
Sub-Investigator: Alexis Gricela, MD         
The Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Deepika Bhasin    212-241-4863    Deepika.Bhasin@mountsinai.org   
Principal Investigator: Patricia Sylla, MD         
Sub-Investigator: Daniel Popowich, MD         
Sub-Investigator: Alexander Greenstein, MD         
Sub-Investigator: Sergey Khaitov, MD         
Sub-Investigator: David Chessin, MD         
United States, Oklahoma
Oklahoma Surgical Hospital Recruiting
Tulsa, Oklahoma, United States, 74137
Contact: Sandy Black    918-477-5117    sblack@oksurg.com   
Principal Investigator: Craig S Johnson, MD         
Sub-Investigator: Bryce W Murray, MD         
United States, Pennsylvania
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Luann Healy       Luann.Healy@ahn.org   
Principal Investigator: James McCormick, DO         
Sub-Investigator: Stanislav Nosik, MD         
Sub-Investigator: Matthew Voth, MD         
United States, Texas
Texas Endosurgery Institute Recruiting
San Antonio, Texas, United States, 78235
Contact: Miguel A Hernandez       fellow@texasendosurgery.com   
Principal Investigator: Morris E Franklin, MD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Erik Bailey       Erik.Bailey@swedish.org   
Principal Investigator: Amir Bastawrous, MD         
Sub-Investigator: Melinda Hawkins, MD         
Sponsors and Collaborators
Intuitive Surgical
Investigators
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Study Director: Shilpa Mehendale Intuitive Surgical Inc

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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: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases