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

Overview

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.

Full Title of Study: “Randomized Trial of Intra-Corporeal Anastomosis for RighT Colectomies (RICART Study)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2020

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.

Interventions

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

Arms, Groups and Cohorts

  • Other: Intra-corporeal
    • Right Hemicolectomy
  • Other: Extra-corporeal
    • Right Hemicolectomy

Clinical Trial Outcome Measures

Primary Measures

  • Return of bowel function
    • Time Frame: up to 2 weeks
    • Flatus and bowel motions

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Spectrum Health Hospitals
  • Provider of Information About this Clinical Study
    • Principal Investigator: James W. Ogilvie, Colorectal Surgeon – Spectrum Health Hospitals
  • Overall Official(s)
    • James W Ogilvie, Jr., MS, Principal Investigator, Spectrum Health Hospitals
  • Overall Contact(s)
    • Julia E Reddy, 616-486-2022, Julia.Reddy@spectrumhealth.org

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