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To compare intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies
This is a prospective multicenter observational study to evaluate outcomes of intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intracorporeal Anastomosis | Participants will undergo either robotic-assisted or laparoscopic surgery with an intracorporeal anastomosis due to begin or malignant Right Colon Disease. |
| |
| Extracorporeal Anastomosis | Participants will undergo either robotic-assisted or laparoscopic surgery with an extracorporeal anastomosis due to begin or malignant Right Colon Disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Right Colectomy with Intracorporeal Anastomosis | Procedure | With the patient under general anesthesia, pneumoperitoneum is achieved by a method of choice of the operating surgeon. Port Placement is completed as per the standard of care. Dissection is performed and the ileocolic vessels are identified. The right mesocolon is mobilized and the ileal mesentery is divided. The transverse colon and ileum are then divided with the stapler. Next, attention is turned to constructing the anastomosis. For this purpose, the terminal ileum and the transverse colon stump are brought together. A colotomy and ileostomy is created to form a common channel. The common enterotomy is then closed as per the surgeon's standard of care. The specimen is extracted through an off-midline incision (muscle splitting transverse incision, Pfannenstiel). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of incisional hernia at one year after index procedure. | The primary endpoint of the study is the incidence of incisional hernia for intracorporeal and extracorporeal anastomoses within one year after the right colectomy procedure. Incidence of incisional hernia either patient self-reported or clinical diagnosis will be assessed at one year after the right colectomy procedure. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first flatus after index procedure | The secondary endpoint of the study is time to first flatus for intracorporeal and extracorporeal anastomoses after the right colectomy procedure. Time to first flatus is defined as days from a right colectomy procedure to first occurrence of flatus during subject's post-operative recovery. | up to 1 week after index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Subject undergoing either laparoscopic or robotic-assisted right colectomy for benign or malignant right colon disease
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| Name | Affiliation | Role |
|---|---|---|
| Shilpa Mehendale | Intuitive Surgical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Irvine | California | 92697 | United States | ||
| St. Joseph Mercy Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41145697 | Derived | Cleary RK, Silviera M, Reidy TJ, McCormick J, Johnson CS, Sylla P, Cannon J, Lujan H, Kassir A, Landmann RG, Gaertner W, Lee E, Bastawrous AL, Bardakcioglu O, Pandey S, Attaluri V, Bernstein M, Obias V, Pigazzi A. Extraction site hernia and short-term outcomes following intracorporeal versus extracorporeal anastomosis for robotic and laparoscopic right colectomy: a multi-center prospective trial. Surg Endosc. 2026 Jan;40(1):502-511. doi: 10.1007/s00464-025-12327-7. Epub 2025 Oct 27. |
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| Right Colectomy with Extracorporeal Anastomosis | Procedure | With the patient under general anesthesia, pneumoperitoneum is achieved by a method of choice of the operating surgeon. Port Placement is completed as per the standard of care. Dissection is performed and the ileocolic vessels are identified. Intracorporeal devascularization may be performed at the surgeon's discretion. The gastrocolic ligament is taken down and the hepatic flexure is mobilized. After complete mobilization of the right colon, the midline incision is extended to serve as the extraction site. The specimen is delivered through the midline extraction incision and the anastomosis is conducted in a standard open technique. The two cut ends of the bowels are aligned for extracorporeal anastomosis. |
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| Ann Arbor |
| Michigan |
| 48197 |
| United States |
| Washington University at St. Louis | St Louis | Missouri | 63110 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |