TICAP - Titanium Clips for Appendiceal Stump Closure

NCT ID: NCT01734837

Last Updated: 2015-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

390 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Appendicitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DS-Ligature Clip

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* indication for a laparoscopic appendectomy
* informed consent


* 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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aesculap, Inc.

INDUSTRY

Sponsor Role collaborator

Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Marina del Rey Hospital

Marina del Rey, California, United States

Site Status

St. Luke's University Hospital

Bethlehem, Pennsylvania, United States

Site Status

Vivantes Humboldt-Klinikum

Berlin, , Germany

Site Status

DRK Krankenhaus Clementinen

Hanover, , Germany

Site Status

University of Mainz, Department of Surgery

Mainz, , Germany

Site Status

Universitätsklinikum Mannheim

Mannheim, , Germany

Site Status

Klinikum Memmingen

Memmingen, , Germany

Site Status

Katharinenhospital

Stuttgart, , Germany

Site Status

Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

Villingen-Schwenningen, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 26185103 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AAG-O-H-1111

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.