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Completed

NCT Number: NCT01734837

TICAP - Titanium 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.

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Key information

Conditions

Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vivantes Humboldt-Klinikum, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DS-Ligature Clip

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. Intra- and post-operative complications related to surgery

    Time frame: 30 days after surgery

  2. Duration of operation

    Time frame: intra-operative

  3. Conversion rate to open surgery

    Time frame: 30 days

  4. Length of hospitalization

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • Aesculap, Inc.

Registry information

Official study title

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

Acronym: TICAP

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 28, 2012
Registry last updated
Sep 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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