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

Duomed

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Colon Cancer

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of patients with adverse events related to the index-procedure.

Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.

Time frame: 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.

Time frame: 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.

Time frame: 6 months follow-up

Secondary Outcomes

Number of adverse device effects.

Determination of the sharpness of the blade and occurrence of disruption of the staple line.

Time frame: 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.

Time frame: 3 months follow-up

Number of adverse device effects.

Determination of the sharpness of the blade and occurrence of disruption of the staple line.

Time frame: 6 months follow-up

Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.

Time frame: 3 to 4 weeks follow-up

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.