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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Disorders

Intervention / Treatment
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* Procedure: Right Hemicolectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |