Clinical trial NCT03862781: Intra-Corporeal Anastomosis Result in Quicker Return of Bowel Function/Earlier Discharge
Official title: Randomized Trial of Intra-Corporeal Anastomosis for RighT Colectomies (RICART Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Disorders
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After the participants have been consented to the study, the study 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.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Return of bowel function
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Inpatient length of stay
timeFrame: up to 2 weeks
measure: Incision length
timeFrame: Surgery date
measure: Postoperative narcotic use
timeFrame: up to 2 weeks
measure: Surgical site infection
timeFrame: up to 6 weeks
measure: Perioperative morbidity
timeFrame: Baseline (Prior to surgery)
measure: Operating room charges
timeFrame: Surgery date
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group
state: Michigan
Study officials:
affiliation: Spectrum Health Hospitals
name: James W Ogilvie, Jr., MS
role: PRINCIPAL_INVESTIGATOR
References: