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Single Incision Versus Conventional Laparoscopic Appendectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dolores Frutos Bernal, Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier:
NCT01515293
First received: January 18, 2012
Last updated: January 23, 2012
Last verified: May 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Appendicitis
 Procedure: Single Incision Laparoscopic Appendectomy
Procedure: Conventional appendectomy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomised Study Comparing Single Incision Transumbilical Versus Conventional Laparoscopic Appendectomy

Resource links provided by NLM:

MedlinePlus related topics: Appendicitis
U.S. FDA Resources

Further study details as provided by Hospital Universitario Virgen de la Arrixaca:

Enrollment: 184
Study Start Date: September 2009
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Incision Laparoscopic Appendectomy Procedure: Single Incision Laparoscopic Appendectomy
Experimental: Conventional appendectomy
Conventional appendectomy
 Procedure: Conventional appendectomy

Detailed 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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Patients with suspected acute appendicitis

Exclusion Criteria:

  • Perforated appendicitis
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dolores Frutos Bernal, Dolores Frutos HUV Arrixaca, Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier: NCT01515293     History of Changes
Other Study ID Numbers: HUV-APP-MDFB
Study First Received: January 18, 2012
Last Updated: January 23, 2012
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Appendicitis
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Cecal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 22, 2013