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

Overview

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.

Full Title of Study: “Prospective, Randomized Study of Single Port and Conventional Laparoscopic Appendectomy in Acute Appendicitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2010

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.

Interventions

  • Procedure: Single port laparoscopic appendectomy
    • Single port through the transumbilical 2-cm incision
  • Procedure: 3 port laparoscopic appendectomy
    • 3 trocars was inserted in infraumbilical, left lower quadrant, and suprapubic area

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: 3 port
    • 3 port laparoscopic appendectomy was done by conventional method

Clinical Trial Outcome Measures

Primary Measures

  • Safety
    • Time Frame: 1 month
    • 30 day morbidity and mortality

Secondary 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
    • Cost

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kyunghee University Medical Center
  • Collaborator
    • KyungHee University School of Medicine, Korea
  • Provider of Information About this Clinical Study
    • Principal Investigator: Byung Mo Kang, Professor – Kyunghee University Medical Center
  • Overall Official(s)
    • Suk Hwan Lee, MD. PhD, Principal Investigator, Kyung Hee University School of Medicine

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