Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy

Study Overview
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Brief Summary
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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.

Official Title
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Assessing the Safety and Performance of the Single Use Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy: a Monocentric Post-market Observational Study

Conditions
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Colon Cancer

Intervention / Treatment
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* Device: Endoscopic Linear Cutter Stapler and Reloads (Frankenman)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at study entry is at least 18 years. Patient must sign and date the informed consent form prior to the index-procedure. Patient has a tumor in the ascending colon. Exclusion Criteria: Patient is pregnant. Patient has inflammatory bowel disease (ulcerative colitis, Crohn's disease). Patient has symptomatic diverticulitis. Patient has bowel trauma. Patient has peritoneal carcinomatosis. Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colon cancer patients<br>Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy. | Device: Endoscopic Linear Cutter Stapler and Reloads (Frankenman)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ascending colon