TICAP - Titanium Clips for Appendiceal Stump Closure (TICAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01734837
Recruitment Status : Completed
First Posted : November 28, 2012
Last Update Posted : September 9, 2015
Aesculap, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Appendicitis Device: DS-Ligature Clip

Study Type : Observational
Actual Enrollment : 390 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multicenter Observational Study (Registry) on the Aesculap DS Titanium Ligation Clips for Appendiceal Stump Closure.
Study Start Date : October 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Primary Outcome Measures :
  1. Applicability/feasibility of the DS Clips [ Time Frame: 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 :
  1. Intra- and post-operative complications related to surgery [ Time Frame: 30 days after surgery ]
  2. Duration of operation [ Time Frame: intra-operative ]
  3. Conversion rate to open surgery [ Time Frame: 30 days ]
  4. Length of hospitalization [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult patients and children


  • 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


  • patient age under 16 years
  • appendix is severely inflamed with involvement of the caecum

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01734837

United States, California
Marina del Rey Hospital
Marina del Rey, California, United States, 90292
United States, Pennsylvania
St. Luke's University Hospital
Bethlehem,, Pennsylvania, United States, 18015
Vivantes Humboldt-Klinikum
Berlin, Germany, 13509
DRK Krankenhaus Clementinen
Hannover, Germany, 30161
University of Mainz, Department of Surgery
Mainz, Germany, 55131
Universitätsklinikum Mannheim
Mannheim, Germany, 68167
Klinikum Memmingen
Memmingen, Germany, 87700
Stuttgart, Germany, 70174
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, Germany, 7805
Sponsors and Collaborators
Aesculap AG
Aesculap, Inc.

Publications of Results:
Responsible Party: Aesculap AG Identifier: NCT01734837     History of Changes
Other Study ID Numbers: AAG-O-H-1111
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015

Keywords provided by Aesculap AG:
Laparoscopic appendectomy
appendical stump closure

Additional relevant MeSH terms:
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases