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Safety and Efficacy Study of Single Port Laparoscopic Appendectomy in Acute Appendicitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by Kyunghee University Medical Center.
Recruitment status was:  Recruiting
KyungHee University School of Medicine, Korea
Information provided by:
Kyunghee University Medical Center Identifier:
First received: November 3, 2009
Last updated: May 26, 2010
Last verified: November 2009
The aim of this study is to investigate the safety and efficacy of single port laparoscopic appendectomy compared with conventional laparoscopic appendectomy in adults with acute appendicitis.

Condition Intervention
Procedure: Single port laparoscopic appendectomy
Procedure: 3 port laparoscopic appendectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized Study of Single Port and Conventional Laparoscopic Appendectomy in Acute Appendicitis

Resource links provided by NLM:

Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • Safety [ Time Frame: 1 month ]
    30 day morbidity and mortality

Secondary Outcome Measures:
  • Efficacy [ Time Frame: 1 day ]
    Operative time

  • Efficacy [ Time Frame: 2 days ]
    Postoperative pain score

  • Efficacy [ Time Frame: 2 days ]
    Postoperative functional recovery

  • Efficacy [ Time Frame: 7 days ]
    Duration of postoperative hospital stay

  • Efficacy [ Time Frame: 7 days ]

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single port
Single port through the transumbilical incision was made by wound retractor combined with surgical glove and then 3 trocal was inserted to the finger part of the surgical glove. Laparoscopic instrument was working through the single port and resected appendix removed through it.
Procedure: Single port laparoscopic appendectomy
Single port through the transumbilical 2-cm incision
Other Name: single port laparoscopic surgery
Active Comparator: 3 port
3 port laparoscopic appendectomy was done by conventional method
Procedure: 3 port laparoscopic appendectomy
3 trocars was inserted in infraumbilical, left lower quadrant, and suprapubic area
Other Name: conventional laparoscopic appendectomy

Detailed Description:
Laparoscopic appendectomy improved the postoperative functional outcomes in the treatment of acute appendectomy. In addition, recently single port laparoscopic surgery was introduced in the laparoscopy-dedicated center. When compared with conventional 3 port laparoscopic appendectomy, single port laparoscopic appendectomy was expected to be less painful, more rapid recovery of bowel function, and better cosmetic. In this prospective randomized trial, we tried to investigate the superiority of this new technique in adult patients with acute appendectomy.

Ages Eligible for Study:   7 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinically diagnosed acute appendicitis

Exclusion Criteria:

  • Age less than 7 or more than 75 years old
  • Gangrenous appendicitis
  • Combined generalized peritonitis
  • ASA score more than 3 point
  • Pregnant women
  • Cases requiring draining tube
  Contacts and Locations
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Please refer to this study by its identifier: NCT01007318

Contact: Byung Mo Kang, MD 82-2-440-6260

Korea, Republic of
Kyung Hee University School of Medicine, Neo Medical Center Recruiting
Seoul, Korea, Republic of, 134-727
Contact: Byung Mo Kang, MD.    82-2-440-6260   
Principal Investigator: Suk Hwan Lee, MD. PhD         
Sponsors and Collaborators
Kyunghee University Medical Center
KyungHee University School of Medicine, Korea
Principal Investigator: Suk Hwan Lee, MD. PhD Kyung Hee University School of Medicine
  More Information

Responsible Party: Suk Hwan Lee, Kyung Hee University School of Medicine Identifier: NCT01007318     History of Changes
Other Study ID Numbers: khnmc IRB 2009-026
Study First Received: November 3, 2009
Last Updated: May 26, 2010

Additional relevant MeSH terms:
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases processed this record on May 25, 2017