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

Colorectal Disorders Clinical Trial

— RICART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03862781
• Other study ID #: 2018-139
• Status: Recruiting
• Phase: N/A
• Start date: January 28, 2019
• Est. completion date: January 2026

Study information

• Verified date: January 2024
• Source: Spectrum Health Hospitals
• Contact: Hannah R Wheeler
• Phone: 616-486-9834
• Email: hannah.wheeler[@]corewellhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: January 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Spectrum Health Medical Group	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

Outcome

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