TICAP - Titanium Clips for Appendiceal Stump Closure (TICAP)

September 8, 2015 updated by: Aesculap AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

390

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

adult patients and children

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Intra- and post-operative complications related to surgery
Time Frame: 30 days after surgery
30 days after surgery
Duration of operation
Time Frame: intra-operative
intra-operative
Conversion rate to open surgery
Time Frame: 30 days
30 days
Length of hospitalization
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Collaborators

Aesculap, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

October 25, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Estimate)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 8, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-1111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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