TICAP - Titanium Clips for Appendiceal Stump Closure

Completed

• Conditions: Appendicitis

• Registration Number: NCT01734837
• Lead Sponsor: Aesculap AG

Brief Summary

Laparoscopic appendectomy is progressively accepted as the treatment of choice for acute appendicitis. Although the surgical technique of laparoscopic appendectomy has been well established, some controversy exists regarding the closure of the appendiceal stump. The available methods for stump closure are currently: pre-knotted loops (Roeder Loops or Endoloop, linear stapler and polymeric clips. A new device is a the DS Titanium Ligation Clip. The design of the DS-Clip is characterized by two parallel shanks.

The aim of this study is to collect data of a large number of patients treated with the product in real-life clinical routine.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-28
• Primary Completion: 2013-07
• Study Completion: 2013-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-08
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Applicability/feasibility of the DS Clips	30 days after surgery	Documentation of the number of successful (= completed stump closure) versus non-successful (= clip could not be applied) applications of the DS-Clip

Secondary Outcome Measures

Name	Time	Method
Intra- and post-operative complications related to surgery	30 days after surgery
Conversion rate to open surgery	30 days
Length of hospitalization	30 days
Duration of operation	intra-operative

Trial Locations

Locations (9)

Marina del Rey Hospital; 🇺🇸 Marina del Rey, California, United States

Vivantes Humboldt-Klinikum; 🇩🇪 Berlin, Germany

St. Luke's University Hospital; 🇺🇸 Bethlehem,, Pennsylvania, United States

DRK Krankenhaus Clementinen; 🇩🇪 Hannover, Germany

University of Mainz, Department of Surgery; 🇩🇪 Mainz, Germany

Universitätsklinikum Mannheim; 🇩🇪 Mannheim, Germany

Klinikum Memmingen; 🇩🇪 Memmingen, Germany

Katharinenhospital; 🇩🇪 Stuttgart, Germany

Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH; 🇩🇪 Villingen-Schwenningen, Germany