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

Randomized Trial of Intra-Corporeal Anastomosis for RighT Colectomies (RICART Study)

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Disorders
• Intervention / Treatment: Procedure: Right Hemicolectomy

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.

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannah R Wheeler; Phone Number: 616-486-9834; Email: hannah.wheeler@corewellhealth.org
• Study Contact Backup: Name: Julia Karum; Email: Julia.karum@corewellhealth.org

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • Spectrum Health Medical Group
      • Principal Investigator: James Ogilvie, MS
      • Contact: Hannah R Wheeler; Phone Number: 616-486-9834; Email: hannah.wheeler@corewellhealth.org
      • Contact: Julia E Karum; Phone Number: 616-486-2022; Email: Julia.Karum@corewellhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intra-corporeal; Right Hemicolectomy	Procedure: Right Hemicolectomy; Minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis.
Other: Extra-corporeal; Right Hemicolectomy	Procedure: Right Hemicolectomy; Minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return of bowel function	Flatus and bowel motions	up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inpatient length of stay	Days in the hospital after surgery	up to 2 weeks
Incision length	cm's	Surgery date
Postoperative narcotic use	Average pain scores over first 5 hospital days	up to 2 weeks
Surgical site infection	(superficial, deep and organ-space)	up to 6 weeks
Perioperative morbidity	Disease state	Baseline (Prior to surgery)
Operating room charges	Fees for operating room	Surgery date

Collaborators and Investigators

• Sponsor: Spectrum Health Hospitals
• Investigators: Principal Investigator: James W Ogilvie, Jr., MS, Spectrum Health Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2019
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 5, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 20, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2018-139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to Share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No