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The primary objective of this study is to evaluate the performance of SureFormâ„¢ Staplers (60 and 45) for transection and/or creation of anastomosis during robotic-assisted colorectal procedures.
This is a prospective, single-center observational study to evaluate the performance of SureFormâ„¢ Staplers during robotic-assisted resections of either ascending or transverse or descending or sigmoid colon or rectum. Subjects with either a suspected or confirmed benign or malignant disease of the colon and rectum who are scheduled to undergo a robotic-assisted resection of the colon or rectum will be asked to provide informed consent for their participation in the study.
The study will be conducted at one institution with two surgeons performing the colorectal procedures. The surgeons will be using either the da Vinci Xi or X Surgical System which ever they use as per their standard of care for the colorectal procedure. Stapling will be performed with SureFormâ„¢ Staplers and any of the reloads as per the surgeon's standard of care for the transection and/or creation of anastomosis during robotic-assisted colorectal procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic-assisted colorectal resection | Subjects with either a suspected or confirmed benign or malignant disease of the colon and rectum who are scheduled to undergo a robotic-assisted resection of the colon or rectum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colorectal resection | Procedure | Robotic-assisted resection of the colon or rectum in subjects with benign or malignant colon or rectal disease, where SureFormâ„¢ Staplers are utilized for transection and/or creation of anastomosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of SureFormâ„¢ Stapler fires and reload colors | The primary endpoint of the study is to assess the number of fires and reload colors of SureFormâ„¢ Staplers utilized for the transection and/or creation of anastomosis during robotic-assisted colorectal procedures. | During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of peri-operative and short term outcomes | The secondary endpoint of the study is to assess the incidence of peri-operative and short term outcomes following transection and/or creation of anastomosis using SureFormâ„¢ Staplers during robotic-assisted colorectal procedures. | 30 days post-operative |
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Inclusion Criteria:
Exclusion Criteria:
Intra-Operative Exclusion Criteria:
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Subject undergoing robotic-assisted colorectal procedure for suspected or confirmed benign or malignant colon or rectal disease.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma Surgical Hospital | Tulsa | Oklahoma | 74137 | United States |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |