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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-28

Study Completion Date

2027-12-31

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.

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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.

Conditions

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Colorectal Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

The patients, nursing staff and the perioperative care team (physician assistants, residents) will be blinded.

Study Groups

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Intra-corporeal

Right Hemicolectomy

Group Type OTHER

Right Hemicolectomy

Intervention Type PROCEDURE

Minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis.

Extra-corporeal

Right Hemicolectomy

Group Type OTHER

Right Hemicolectomy

Intervention Type PROCEDURE

Minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis.

Interventions

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Right Hemicolectomy

Minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No