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

Not Applicable

Completed

• Conditions: Appendicitis
• Interventions: Procedure: Single port laparoscopic appendectomy; Procedure: 3 port laparoscopic appendectomy

• Registration Number: NCT01007318
• Lead Sponsor: Kyunghee University Medical Center

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2009-11-03
• Study First Submitted QC: 2009-11-03
• Study First Posted: 2009-11-04
• Study Start: 2009-12
• Primary Completion: 2010-12
• Study Completion: 2016-02
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single port	Single port laparoscopic appendectomy	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.
3 port	3 port laparoscopic appendectomy	3 port laparoscopic appendectomy was done by conventional method

Primary Outcome Measures

Name	Time	Method
Safety	1 month	30 day morbidity and mortality

Secondary Outcome Measures

Name	Time	Method
Efficacy	7 days	Cost

Trial Locations

Locations (1)

Kyung Hee University School of Medicine, Neo Medical Center; 🇰🇷 Seoul, Korea, Republic of