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

Appendicitis Clinical Trial

Official title:

Prospective, Randomized Study of Single Port and Conventional Laparoscopic Appendectomy in Acute Appendicitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007318
• Other study ID #: khnmc IRB 2009-026
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Est. completion date: February 2016

Study information

• Verified date: September 2020
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: February 2016
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University School of Medicine, Neo Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Kyunghee University Medical Center	KyungHee University School of Medicine, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	30 day morbidity and mortality	1 month
Secondary	Efficacy	Operative time	1 day
Secondary	Efficacy	Postoperative pain score	2 days
Secondary	Efficacy	Postoperative functional recovery	2 days
Secondary	Efficacy	Duration of postoperative hospital stay	7 days
Secondary	Efficacy	Cost	7 days