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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 21, 2014