Colon Cancer
Conditions
Keywords
Ascending colon
Brief summary
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.
Interventions
DEVICEEndoscopic Linear Cutter Stapler and Reloads (Frankenman)
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.
Sponsors
Duomed
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events related to the index-procedure. | 3 to 4 weeks follow-up | Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse device effects. | 3 to 4 weeks follow-up | Determination of the sharpness of the blade and occurrence of disruption of the staple line. |
| 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 colectomy related re-interventions. | 3 to 4 weeks follow-up | — |
Outcome results
None listed