Single Incision Versus Conventional Laparoscopic Appendectomy

Appendicitis Clinical Trial

Official title:

Prospective Randomised Study Comparing Single Incision Transumbilical Versus Conventional Laparoscopic Appendectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515293
• Other study ID #: HUV-APP-MDFB
• Status: Completed
• Phase: Phase 3
• First received: January 18, 2012
• Last updated: January 23, 2012
• Start date: September 2009

Study information

• Verified date: May 2011
• Source: Hospital Universitario Virgen de la Arrixaca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the short-term outcomes of single-incision and conventional laparoscopic appendectomy.

Description:

Appendicitis is the most common abdominal emergency. The treatment is surgical and single incision laparoscopic surgery (SILS) involves performing laparoscopic surgery through a single transumbilical point, in an attempt to improve the results of laparoscopic surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. primary completion date: December 2010
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Patients with suspected acute appendicitis

Exclusion Criteria:

• Perforated appendicitis

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis

Intervention

Procedure:
• Single Incision Laparoscopic Appendectomy

• Conventional appendectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Virgen de la Arrixaca