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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-corporeal | Other | Right Hemicolectomy |
|
| Extra-corporeal | Other | Right Hemicolectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Right Hemicolectomy | Procedure | Minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Return of bowel function | Flatus and bowel motions | up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inpatient length of stay | Days in the hospital after surgery | up to 2 weeks |
| Incision length | cm's | Surgery date |
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Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded from the study intra-operatively if:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| kendra Selby | Contact | 616-486-0281 | kendra.selby@helendevoschidrens.org | |
| Ellen Derrer | Contact | ellen.derrer@corewellhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| James W Ogilvie, Jr., MS | Corewell Health West | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spectrum Health Medical Group | Recruiting | Grand Rapids | Michigan | 49546 | United States |
There is no plan to Share IPD.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 20, 2025 | Jun 20, 2025 | ICF_005.pdf |
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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.
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The patients, nursing staff and the perioperative care team (physician assistants, residents) will be blinded.
| 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 |