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TICAP - Titanium Clips for Appendiceal Stump Closure

This study has been completed.
Sponsor:
Collaborator:
Aesculap, Inc.
Information provided by (Responsible Party):
Aesculap AG
ClinicalTrials.gov Identifier:
NCT01734837
First received: October 25, 2012
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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 Intervention
Appendicitis
Device: DS-Ligature Clip

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multicenter Observational Study (Registry) on the Aesculap DS Titanium Ligation Clips for Appendiceal Stump Closure.

Resource links provided by NLM:


Further study details as provided by Aesculap AG:

Primary Outcome Measures:
  • Applicability/feasibility of the DS Clips [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    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:
  • Intra- and post-operative complications related to surgery [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
  • Duration of operation [ Time Frame: intra-operative ] [ Designated as safety issue: No ]
  • Conversion rate to open surgery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Length of hospitalization [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: October 2011
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: DS-Ligature Clip
    N/A
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

adult patients and children

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734837

Locations
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
Germany
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
Katharinenhospital
Stuttgart, Germany, 70174
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, Germany, 7805
Sponsors and Collaborators
Aesculap AG
Aesculap, Inc.
  More Information

No publications provided

Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT01734837     History of Changes
Other Study ID Numbers: AAG-O-H-1111
Study First Received: October 25, 2012
Last Updated: November 22, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Aesculap AG:
Laparoscopic appendectomy
appendical stump closure

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

ClinicalTrials.gov processed this record on November 20, 2014