TICAP - Titanium Clips for Appendiceal Stump Closure

Appendicitis Clinical Trial

— TICAP  

Official title:

Prospective Multicenter Observational Study (Registry) on the Aesculap DS Titanium Ligation Clips for Appendiceal Stump Closure.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734837
• Other study ID #: AAG-O-H-1111
• Status: Completed
• Phase: N/A
• First received: October 25, 2012
• Last updated: September 8, 2015
• Start date: October 2011
• Est. completion date: August 2013

Study information

• Verified date: September 2015
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion:

• indication for a laparoscopic appendectomy

• informed consent

Inclusion criteria to be checked intraoperatively:

• conventional laparoscopic approach (no SILS, NOTES, SPA)

• Aesculap DS Titanium Ligation Clips were used

Exclusion:

• patient age under 16 years

• appendix is severely inflamed with involvement of the caecum

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Appendicitis

Intervention

Device:
• DS-Ligature Clip

Locations

Country	Name	City	State
Germany	Vivantes Humboldt-Klinikum	Berlin
Germany	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
United States	St. Luke's University Hospital	Bethlehem,	Pennsylvania
United States	Marina del Rey Hospital	Marina del Rey	California

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	Aesculap, Inc.

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (1)

Rickert A, Krüger CM, Runkel N, Kuthe A, Köninger J, Jansen-Winkeln B, Gutt CN, Marcus DR, Hoey B, Wente MN, Kienle P. The TICAP-Study (titanium clips for appendicular stump closure): A prospective multicentre observational study on appendicular stump clo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Applicability/feasibility of the DS Clips	Documentation of the number of successful (= completed stump closure) versus non-successful (= clip could not be applied) applications of the DS-Clip	30 days after surgery	No
Secondary	Intra- and post-operative complications related to surgery		30 days after surgery	No
Secondary	Duration of operation		intra-operative	No
Secondary	Conversion rate to open surgery		30 days	No
Secondary	Length of hospitalization		30 days	No