Colorectal Disorders
Conditions
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.
Interventions
PROCEDURERight Hemicolectomy
Minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis.
Sponsors
Corewell Health West
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
The patients, nursing staff and the perioperative care team (physician assistants, residents) will be blinded.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Return of bowel function | up to 2 weeks | Flatus and bowel motions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inpatient length of stay | up to 2 weeks | Days in the hospital after surgery |
| Incision length | Surgery date | cm's |
| Postoperative narcotic use | up to 2 weeks | Average pain scores over first 5 hospital days |
| Surgical site infection | up to 6 weeks | (superficial, deep and organ-space) |
| Perioperative morbidity | Baseline (Prior to surgery) | Disease state |
| Operating room charges | Surgery date | Fees for operating room |
Countries
United States
Contacts
CONTACTkendra Selby
CONTACTEllen Derrer
PRINCIPAL_INVESTIGATORJames W Ogilvie, Jr., MS
Corewell Health West
Outcome results
None listed