TICAP - Titanium Clips for Appendiceal Stump Closure

NCT01734837 | Completed

• 1 other identifier: AAG-O-H-1111
• Study Type: observational
• Target: 390
• Locations: 2 countries
• Sites: 9

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.

Conditions

Appendicitis

Keywords

Laparoscopic appendectomy; appendical stump closure

Outcome Measures

Primary Outcomes (1)

• 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

  30 days after surgery

Secondary Outcomes (4)

• Intra- and post-operative complications related to surgery

  30 days after surgery

• Duration of operation

  intra-operative

• Conversion rate to open surgery

  30 days

• Length of hospitalization

  30 days

Interventions

DS-Ligature Clip DEVICE

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

adult patients and children

You may qualify if:

• indication for a laparoscopic appendectomy
• informed consent
• conventional laparoscopic approach (no SILS, NOTES, SPA)
• Aesculap DS Titanium Ligation Clips were used

You may not qualify if:

• patient age under 16 years
• appendix is severely inflamed with involvement of the caecum

Sponsors & Collaborators

• Aesculap AG: lead
• Aesculap, Inc.: collaborator

Study Sites (9)

Marina del Rey Hospital

Marina del Rey, California, 90292, United States

Location

St. Luke's University Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

Vivantes Humboldt-Klinikum

Berlin, 13509, Germany

Location

DRK Krankenhaus Clementinen

Hanover, 30161, Germany

Location

University of Mainz, Department of Surgery

Mainz, 55131, Germany

Location

Universitätsklinikum Mannheim

Mannheim, 68167, Germany

Location

Klinikum Memmingen

Memmingen, 87700, Germany

Location

Katharinenhospital

Stuttgart, 70174, Germany

Location

Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

Villingen-Schwenningen, 7805, Germany

Location

Related Publications (1)

• 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.

  PMID: 26185103 RESULT

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: November 28, 2012
• Study Start: October 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 9, 2015

Record last verified: 2015-09

Locations

DE (7); US (2)