AppendicitisTICAPNCT01734837
TICAP - Titanium Clips for Appendiceal Stump Closure
An observational study of Appendicitis, run by Aesculap AG at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Appendicitis
- What is being tested?
- DS-Ligature Clip
- Type of treatment
- Medical device
- How many people
- 390 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Oct 2011to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: adult patients and children
Who may be able to join
- indication for a laparoscopic appendectomy
- informed consent
- conventional laparoscopic approach (no SILS, NOTES, SPA)
- Aesculap DS Titanium Ligation Clips were used
Who cannot join
- patient age under 16 years
- appendix is severely inflamed with involvement of the caecum
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany7 sites
Vivantes Humboldt-Klinikum
Berlin, 13509
DRK Krankenhaus Clementinen
Hanover, 30161
University of Mainz, Department of Surgery
Mainz, 55131
Universitätsklinikum Mannheim
Mannheim, 68167
Klinikum Memmingen
Memmingen, 87700
Katharinenhospital
Stuttgart, 70174
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, 7805
United States2 sites
St. Luke's University Hospital
Bethlehem, Pennsylvania, 18015
Marina del Rey Hospital
Marina del Rey, California, 90292
About this study
Official title: 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.
- Conditions
- Appendicitis
- Being tested
- DS-Ligature Clip
- Keywords
- Laparoscopic appendectomy, appendical stump closure
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-Ligature ClipDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Applicability/feasibility of the DS Clips
Documentation of the number of successful (= completed stump closure) versus non-successful (= clip could not be applied) applications of the DS-Clip
Measured: 30 days after surgery
Secondary outcomes (4)
Intra- and post-operative complications related to surgery
Measured: 30 days after surgery
Duration of operation
Measured: intra-operative
Conversion rate to open surgery
Measured: 30 days
Length of hospitalization
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startOct 2011
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aesculap, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734837
- Sponsor's protocol ID
- AAG-O-H-1111
- Acronym
- TICAP
- Status last verified
- Sep 2015
- First submitted
- 25 Oct 2012
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26185103
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Observational Study (Registry) on the Aesculap DS Titanium Ligation Clips for Appendiceal Stump Closure.
- ClinicalTrials.gov ID
- NCT01734837
- Acronym / sponsor ID
- TICAP / AAG-O-H-1111
- Conditions
- Appendicitis
- Keywords
- Laparoscopic appendectomy, appendical stump closure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- Aesculap, Inc.
- Study start
- Oct 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- adult patients and children
Key inclusion criteria (4 listed)
- indication for a laparoscopic appendectomy
- informed consent
- conventional laparoscopic approach (no SILS, NOTES, SPA)
- Aesculap DS Titanium Ligation Clips were used
Key exclusion criteria (2 listed)
- patient age under 16 years
- appendix is severely inflamed with involvement of the caecum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DS-Ligature Clip | Device | – |
Primary outcome
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
4 secondary outcomes
Intra- and post-operative complications related to surgery
Time frame: 30 days after surgery
Duration of operation
Time frame: intra-operative
Conversion rate to open surgery
Time frame: 30 days
Length of hospitalization
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
- Results publication: PubMed 26185103Rickert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis, run by Aesculap AG at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Applicability/feasibility of the DS Clips (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01734837, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2015; AzTrials last refreshed its copy on 28 Oct 2026.