Clinical trial NCT01734837: TICAP - Titanium Clips for Appendiceal Stump Closure
Official title: Prospective Multicenter Observational Study (Registry) on the Aesculap DS Titanium Ligation Clips for Appendiceal Stump Closure.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appendicitis
Keywords: Laparoscopic appendectomy
appendical stump closure
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: Aesculap, Inc.
First posted: 2012-11-28
Enrollment: 390
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients and children

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.


Eligibility criteria: 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

Primary outcomes:
measure: Applicability/feasibility of the DS Clips
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Intra- and post-operative complications related to surgery
timeFrame: 30 days after surgery
measure: Duration of operation
timeFrame: intra-operative
measure: Conversion rate to open surgery
timeFrame: 30 days
measure: Length of hospitalization
timeFrame: 30 days
Other outcomes:
Locations:
city: Marina del Rey
country: United States
facility: Marina del Rey Hospital
state: California
city: Bethlehem,
country: United States
facility: St. Luke's University Hospital
state: Pennsylvania
city: Berlin
country: Germany
facility: Vivantes Humboldt-Klinikum
city: Hannover
country: Germany
facility: DRK Krankenhaus Clementinen
city: Mainz
country: Germany
facility: University of Mainz, Department of Surgery
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Memmingen
country: Germany
facility: Klinikum Memmingen
city: Stuttgart
country: Germany
facility: Katharinenhospital
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Study officials:
References:
citation: Rickert A, Kruger CM, Runkel N, Kuthe A, Koninger 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 closure with an innovative titanium clip. BMC Surg. 2015 Jul 17;15:85. doi: 10.1186/s12893-015-0068-3.