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Design modification
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The purpose of this observational study is to evaluate the safety and performance of the Single Use Endoscopic Linear Cutter Stapler and Reloads from Frankenman used in (hemi)colectomy to remove tumors and create anastomoses in patients with cancer in the ascending colon. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colon cancer patients | Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Linear Cutter Stapler and Reloads (Frankenman) | Device | The Single Use Endoscopic Linear Cutter Stapler and Reloads from Frankenman received CE-mark in April 2013. It is used to staple and simultaneously divide tissue from the central line. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events related to the index-procedure. | Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding. | 3 to 4 weeks follow-up |
| Number of patients with adverse events related to the index-procedure. | Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding. | 3 months follow-up |
| Number of patients with adverse events related to the index-procedure. | Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding. | 6 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse device effects. | Determination of the sharpness of the blade and occurrence of disruption of the staple line. | 3 to 4 weeks follow-up |
| Number of adverse device effects. | Determination of the sharpness of the blade and occurrence of disruption of the staple line. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy.
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| Name | Affiliation | Role |
|---|---|---|
| Kurt Van Der Speeten, Dr | ZOL, Genk | Principal Investigator |
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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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| 3 months follow-up |
| Number of adverse device effects. | Determination of the sharpness of the blade and occurrence of disruption of the staple line. | 6 months follow-up |
| Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy. | 3 to 4 weeks follow-up |
| Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy. | 3 months follow-up |
| Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy. | 6 months follow-up |
| Number of patients with colectomy related re-interventions. | 3 to 4 weeks follow-up |
| Number of patients with colectomy related re-interventions. | 3 months follow-up |
| Number of patients with colectomy related re-interventions. | 6 months follow-up |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |