A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy

NCT01348464 | Completed

• 1 other identifier: girba2339
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Appendicitis

Keywords

appendectomy; appendicitis; laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• Complication rate

  observe complication caused by both procedures

  participants will be followed for the duration of hospital stay, an expected average of 24 weeks

Secondary Outcomes (1)

• patient satisfaction

  participants will be followed for the duration of hospital stay, an expected average of 24 weeks

Study Arms (1)

lifestyle, wound satisfaction

single site access three site access for appendectomy

Procedure: single port appendectomy, three port appendectomy

Interventions

single port appendectomy, three port appendectomy PROCEDURE

visual analog scale. questionnaire on wound satisfaction

Also known as: Pain scale, Satisfactory score, complication rate

lifestyle, wound satisfaction

Eligibility Criteria

• Age: 5 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The cohorts will be the residents of Incheon, Korea

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gachon University Gil Medical Center: lead

Study Sites (1)

Gachon Univ., Gil Medical Center

Incheon, South Korea

Location

Related Publications (1)

• Raakow R, Jacob DA. Initial experience in laparoscopic single-port appendectomy: a pilot study. Dig Surg. 2011;28(1):74-9. doi: 10.1159/000322921. Epub 2011 Feb 4.

  PMID: 21293135 BACKGROUND

Related Links

• laparoscopic surgery teaching site

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Won-Suk Lee, MD

  Gachon Univ. Gil Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant prof

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 5, 2011
• Study Start: March 1, 2010
• Study Completion: December 1, 2011
• Last Updated: April 4, 2012

Record last verified: 2012-04

Locations

KR (1)