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Completed

NCT Number: NCT01348464

A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy

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

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Key information

Conditions

Acute Appendicitis Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

5 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gachon Univ., Gil Medical Center

Incheon, South Korea

About this study

  • primary objective
  • complication rate
  • secondary objectives
  • satisfaction rate
  • pain scale difference

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

single port appendectomy, three port appendectomy

Procedure

visual analog scale. questionnaire on wound satisfaction

Other names: Pain scale, Satisfactory score, complication rate

Primary outcomes

  1. Complication rate

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

    observe complication caused by both procedures

Secondary outcomes

  1. patient satisfaction

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

    Questionarire is given to the patients on postoperative 3days, 1month, 3 months and 6 months

Sponsors and collaborators

Lead sponsor

Gachon University Gil Medical Center

Other

Registry information

Official study title

Transumbilical Single Port Laparoscopic Appendectomy Versus Conventional Laparoscopic Appendectomy in Adult Patients: A Prospective Randomized Control Study

Important dates

Study start
2010
Study completion
2011
First posted
May 5, 2011
Registry last updated
Apr 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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