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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Kyunghee University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
KyungHee University School of Medicine, Korea
Information provided by:
Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01007318
First received: November 3, 2009
Last updated: May 26, 2010
Last verified: November 2009
  Purpose

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
Appendicitis
Procedure: Single port laparoscopic appendectomy
Procedure: 3 port laparoscopic appendectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
    30 day morbidity and mortality


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Operative time

  • Efficacy [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Postoperative pain score

  • Efficacy [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Postoperative functional recovery

  • Efficacy [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Duration of postoperative hospital stay

  • Efficacy [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Cost


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.

  Eligibility

Ages Eligible for Study:   7 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007318

Contacts
Contact: Byung Mo Kang, MD 82-2-440-6260 kbm0728@yahoo.co.kr

Locations
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    kbm0728@yahoo.co.kr   
Principal Investigator: Suk Hwan Lee, MD. PhD         
Sponsors and Collaborators
Kyunghee University Medical Center
KyungHee University School of Medicine, Korea
Investigators
Principal Investigator: Suk Hwan Lee, MD. PhD Kyung Hee University School of Medicine
  More Information

No publications provided

Responsible Party: Suk Hwan Lee, Kyung Hee University School of Medicine
ClinicalTrials.gov Identifier: NCT01007318     History of Changes
Other Study ID Numbers: khnmc IRB 2009-026
Study First Received: November 3, 2009
Last Updated: May 26, 2010
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014