Clinical trial NCT03306966: Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy
Official title: Assessing the Safety and Performance of the Single Use Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy: a Monocentric Post-market Observational Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Colon Cancer
Keywords: Ascending colon
Lead sponsor: Duomed
Sponsor class: INDUSTRY
First posted: 2017-10-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with adverse events related to the index-procedure.
timeFrame: 3 to 4 weeks follow-up
measure: Number of patients with adverse events related to the index-procedure.
timeFrame: 3 months follow-up
measure: Number of patients with adverse events related to the index-procedure.
timeFrame: 6 months follow-up
Secondary outcomes:
measure: Number of adverse device effects.
timeFrame: 3 to 4 weeks follow-up
measure: Number of adverse device effects.
timeFrame: 3 months follow-up
measure: Number of adverse device effects.
timeFrame: 6 months follow-up
measure: Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.
timeFrame: 3 to 4 weeks follow-up
measure: Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.
timeFrame: 3 months follow-up
measure: Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.
timeFrame: 6 months follow-up
measure: Number of patients with colectomy related re-interventions.
timeFrame: 3 to 4 weeks follow-up
measure: Number of patients with colectomy related re-interventions.
timeFrame: 3 months follow-up
measure: Number of patients with colectomy related re-interventions.
timeFrame: 6 months follow-up
Other outcomes:
Locations:
Study officials:
affiliation: ZOL, Genk
name: Kurt Van Der Speeten, Dr
role: PRINCIPAL_INVESTIGATOR
References: