Intra-Corporeal Anastomosis Result in Quicker Return of Bowel Function/Earlier Discharge (RICART)
Randomized Trial of Intra-Corporeal Anastomosis for RighT Colectomies (RICART Study)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: kendra Selby
- Phone Number: 616-486-0281
- Email: kendra.selby@helendevoschidrens.org
Study Contact Backup
- Name: Ellen Derrer
- Email: ellen.derrer@corewellhealth.org
Study Locations
-
-
Michigan
-
Grand Rapids, Michigan, United States, 49546
- Recruiting
- Corewell Health Medical Group
-
Principal Investigator:
- James Ogilvie, MS
-
Contact:
- Julia E reish
- Phone Number: 616-486-2022
- Email: Julia.reish@corewellhealth.org
-
Contact:
- Rachel R Gross
- Email: rachel.gross@corewellhealth.org
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: Intra-corporeal
Right Hemicolectomy
|
Minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis.
|
|
Other: Extra-corporeal
Right Hemicolectomy
|
Minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Return of bowel function
Time Frame: up to 2 weeks
|
Flatus and bowel motions
|
up to 2 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inpatient length of stay
Time Frame: up to 2 weeks
|
Days in the hospital after surgery
|
up to 2 weeks
|
|
Incision length
Time Frame: Surgery date
|
cm's
|
Surgery date
|
|
Postoperative narcotic use
Time Frame: up to 2 weeks
|
Average pain scores over first 5 hospital days
|
up to 2 weeks
|
|
Surgical site infection
Time Frame: up to 6 weeks
|
(superficial, deep and organ-space)
|
up to 6 weeks
|
|
Perioperative morbidity
Time Frame: Baseline (Prior to surgery)
|
Disease state
|
Baseline (Prior to surgery)
|
|
Operating room charges
Time Frame: Surgery date
|
Fees for operating room
|
Surgery date
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: James W Ogilvie, Jr., MS, Corewell Health West
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 2018-139
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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