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

Withdrawn

• Conditions: Colon Cancer
• Interventions: Device: Endoscopic Linear Cutter Stapler and Reloads (Frankenman)

• Registration Number: NCT03306966
• Lead Sponsor: Duomed

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-06
• Study First Submitted QC: 2017-10-06
• Study First Posted: 2017-10-11
• Status Verified: 2018-03
• Study Start: 2018-05-01
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-06-01
• Primary Completion: 2020-05-01
• Study Completion: 2021-01-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colon cancer patients	Endoscopic Linear Cutter Stapler and Reloads (Frankenman)	Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy.

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events related to the index-procedure.	6 months follow-up	Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.

Secondary Outcome Measures

Name	Time	Method
Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.	6 months follow-up
Number of adverse device effects.	6 months follow-up	Determination of the sharpness of the blade and occurrence of disruption of the staple line.
Number of patients with colectomy related re-interventions.	6 months follow-up