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TICAP - Titanium Clips for Appendiceal Stump Closure

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01734837
Acronym
TICAP
Enrollment
390
Registered
2012-11-28
Start date
2011-10-31
Completion date
2013-08-31
Last updated
2015-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis

Keywords

Laparoscopic appendectomy, appendical stump closure

Brief 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. 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.

Interventions

DEVICEDS-Ligature Clip

Sponsors

Aesculap, Inc.
CollaboratorINDUSTRY
Aesculap AG
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Applicability/feasibility of the DS Clips30 days after surgeryDocumentation of the number of successful (= completed stump closure) versus non-successful (= clip could not be applied) applications of the DS-Clip

Secondary

MeasureTime frame
Intra- and post-operative complications related to surgery30 days after surgery
Duration of operationintra-operative
Conversion rate to open surgery30 days
Length of hospitalization30 days

Countries

Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026