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Single Incision Versus Conventional Laparoscopic Appendectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01515293
First Posted: January 24, 2012
Last Update Posted: January 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dolores Frutos Bernal, Hospital Universitario Virgen de la Arrixaca
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomised Study Comparing Single Incision Transumbilical Versus Conventional Laparoscopic Appendectomy

Resource links provided by NLM:


Further study details as provided by Dolores Frutos Bernal, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Patients with suspected acute appendicitis

Exclusion Criteria:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: January 18, 2012
First Posted: January 24, 2012
Last Update Posted: January 24, 2012
Last Verified: May 2011

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