TICAP - Titanium Clips for Appendiceal Stump Closure
This study is currently recruiting participants.
Verified March 2013 by Aesculap AG
Sponsor:
Aesculap AG
Collaborator:
Aesculap, Inc.
Information provided by (Responsible Party):
Aesculap AG
ClinicalTrials.gov Identifier:
NCT01734837
First received: October 25, 2012
Last updated: March 14, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734837
Contacts
| Contact: Valentin Hermanutz, Dr. | +49-7461-95-2633 | valentin.hermanutz@aesculap.de |
Locations
| United States, California | |
| Marina del Rey Hospital | Recruiting |
| Marina del Rey, California, United States, 90292 | |
| Contact: Daniel R Marcus | |
| United States, Pennsylvania | |
| St. Luke's University Hospital | Recruiting |
| Bethlehem,, Pennsylvania, United States, 18015 | |
| Contact: Brian Hoey | |
| Germany | |
| Vivantes Humboldt-Klinikum | Recruiting |
| Berlin, Germany, 13509 | |
| Contact: Colin M. Krüger, Dr. med. Dipl. oec. colin.krueger@vivantes.de | |
| DRK Krankenhaus Clementinen | Recruiting |
| Hannover, Germany, 30161 | |
| Contact: Andreas Kuthe, Dr. | |
| University of Mainz, Department of Surgery | Recruiting |
| Mainz, Germany, 55131 | |
| Contact: Boris Jansen-Winkeln | |
| Universitätsklinikum Mannheim | Recruiting |
| Mannheim, Germany, 68167 | |
| Contact: Peter Kienle, Prof. Dr. peter.kienle@chir.ma.uni-heidelberg.de | |
| Klinikum Memmingen | Recruiting |
| Memmingen, Germany, 87700 | |
| Contact: Carsten N. Gutt, Prof. Dr. med. carsten.gutt@klinikum-memmingen.de | |
| Katharinenhospital | Recruiting |
| Stuttgart, Germany, 70174 | |
| Contact: Jörg Köninger, Prof. Dr. med. j.koeninger@klinikum-stuttgart.de | |
| Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH | Recruiting |
| Villingen-Schwenningen, Germany, 7805 | |
| Contact: Norbert Runkel, Prof. Dr. Dr. h. c. norbert.runkel@sbk-vs.de | |
| United Kingdom | |
| Ysbyty Gwynedd Hospital | Not yet recruiting |
| Bangor, United Kingdom, LL57 2PW | |
| Contact: Graham Whiteley, Dr. graham.whiteley@wales.nhs.uk | |
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: | March 14, 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 Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Cecal Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013