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Intra-Corporeal Anastomosis Result in Quicker Return of Bowel Function/Earlier Discharge (RICART)

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ClinicalTrials.gov Identifier: NCT03862781
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
James W. Ogilvie, Spectrum Health Hospitals

Brief Summary:
Adult patients who are regularly scheduled to undergo a right hemicolectomy via a minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis.

Condition or disease Intervention/treatment Phase
Colorectal Disorders Procedure: Right Hemicolectomy Not Applicable

Detailed Description:
The purpose of this trial is to investigate whether minimally invasive right colectomies done with an intra-corporeal anastomosis result in quicker return of bowel function and earlier discharge. The primary endpoint of this study will be return of bowel function as measured by passage of flatus and bowel motions. The secondary endpoints will be inpatient length of stay, incision length, postoperative narcotic use, surgical site infection (superficial, deep and organ-space), perioperative morbidity and operating room charges.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After the participants have been consented to the study, the nurse coordinator will refer to the randomization schedule, and alert the surgeon whether creation of the anastomosis will be done in either an intra-corporeal or extra-corporeal fashion.
Masking: Single (Participant)
Masking Description: The patients, nursing staff and the perioperative care team (physician assistants, residents) will be blinded.
Primary Purpose: Basic Science
Official Title: Randomized Trial of Intra-Corporeal Anastomosis for RighT Colectomies (RICART Study)
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
Intra-corporeal
Right Hemicolectomy
Procedure: Right Hemicolectomy
Minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis.

Extra-corporeal
Right Hemicolectomy
Procedure: Right Hemicolectomy
Minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis.




Primary Outcome Measures :
  1. Return of bowel function [ Time Frame: up to 2 weeks ]
    Flatus and bowel motions


Secondary Outcome Measures :
  1. Inpatient length of stay [ Time Frame: up to 2 weeks ]
    Days in the hospital after surgery

  2. Incision length [ Time Frame: Surgery date ]
    cm's

  3. Postoperative narcotic use [ Time Frame: up to 2 weeks ]
    Average pain scores over first 5 hospital days

  4. Surgical site infection [ Time Frame: up to 6 weeks ]
    (superficial, deep and organ-space)

  5. Perioperative morbidity [ Time Frame: Baseline (Prior to surgery) ]
    Disease state

  6. Operating room charges [ Time Frame: Surgery date ]
    Fees for operating room



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible patients are those over 18 years of age who are regularly scheduled to undergo a right hemicolectomy via a minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis. Right colectomy will be defined as removal of the ascending colon, ligation of the ileocolic artery and vein, +/- removal of the terminal ileum, +/- removal of the proximal transverse colon, and +/- removal of the right branch of the middle colic artery and vein.

Exclusion Criteria:

  • Pregnant women
  • Additional colon resection is planned (i.e. left colectomy or proctectomy)
  • Vulnerable populations such as prisoners or adults unable to give consent
  • If the scheduled surgery is planned at Butterworth hospital (as to standardize the nursing care received postoperatively)
  • Emergent cases

Patients will be excluded from the study intra-operatively if:

  • The procedure is converted to an open resection
  • If a loop ileostomy is performed in addition to the right colectomy

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): NCT03862781


Contacts
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Contact: Trudi L Nelson, BSN 616-391-8366 Trudi.Nelson@spectrumhealth.org

Locations
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United States, Michigan
Spectrum Health Medical Group Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Trudi Nelson, BSN    616-391-8366    Trudi.Nelson@spectrumhealth.org   
Contact: Roberto Cannizzo, MPH    616-486-2051    roberto.cannizzo@spectrumhealth.org   
Principal Investigator: James Ogilvie, MS         
Sponsors and Collaborators
Spectrum Health Hospitals
Investigators
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Principal Investigator: James W Ogilvie, Jr., MS Spectrum Health Hospitals
  Study Documents (Full-Text)

Documents provided by James W. Ogilvie, Spectrum Health Hospitals:
Informed Consent Form  [PDF] January 8, 2019


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Responsible Party: James W. Ogilvie, Colorectal Surgeon, Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT03862781     History of Changes
Other Study ID Numbers: 2018-139
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to Share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No