A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Won-Suk Lee, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01348464
First received: April 29, 2011
Last updated: April 2, 2012
Last verified: April 2012
  Purpose

The aim of this study is to compare patients who undergone single-port access laparoscopic appendectomy to those who underwent conventional three-port laparoscopic appendectomy (TPLA) in a prospective randomized trial


Condition Intervention
Acute Appendicitis
Procedure: single port appendectomy, three port appendectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transumbilical Single Port Laparoscopic Appendectomy Versus Conventional Laparoscopic Appendectomy in Adult Patients: A Prospective Randomized Control Study

Resource links provided by NLM:


Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • Complication rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 24 weeks ] [ Designated as safety issue: No ]
    observe complication caused by both procedures


Secondary Outcome Measures:
  • patient satisfaction [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 24 weeks ] [ Designated as safety issue: No ]
    Questionarire is given to the patients on postoperative 3days, 1month, 3 months and 6 months


Enrollment: 150
Study Start Date: March 2010
Study Completion Date: December 2011
Groups/Cohorts Assigned Interventions
lifestyle, wound satisfaction
single site access three site access for appendectomy
Procedure: single port appendectomy, three port appendectomy
visual analog scale. questionnaire on wound satisfaction
Other Names:
  • Pain scale
  • Satisfactory score
  • complication rate

Detailed Description:
  • primary objective

    1. complication rate

  • secondary objectives

    1. satisfaction rate
    2. pain scale difference
  Eligibility

Ages Eligible for Study:   5 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The cohorts will be the residents of Incheon, Korea

Criteria

Inclusion Criteria:

  • age 5~85 years
  • any patient diagnosed with acute appendicitis on appendix sonography or abdominopelvic CT
  • Patient performance status(PS) with greater than 80 or more on Karnofsky PS
  • Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

Exclusion Criteria:

  • Pregnant or lactating
  • Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
  • History of Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently treated cancer
  • Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348464

Locations
Korea, Republic of
Gachon Univ., Gil Medical Center
Incheon, Korea, Republic of
Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
Principal Investigator: Won-Suk Lee, MD Gachon Univ. Gil Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Won-Suk Lee, Assistant prof, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01348464     History of Changes
Other Study ID Numbers: girba2339
Study First Received: April 29, 2011
Last Updated: April 2, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Gachon University Gil Medical Center:
appendectomy
appendicitis
laparoscopic surgery

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014