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

Kyung Hee University

Status: Completed

Conditions: Appendicitis

Treatments: Procedure: 3 port laparoscopic appendectomy; Procedure: Single port laparoscopic appendectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01007318

khnmc IRB 2009-026

Details and patient eligibility

About

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 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.

Enrollment: 194 patients

Sex: All

Ages: 7 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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194 participants in 2 patient groups

Single port

Active Comparator group

Description:

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.

Treatment:

Procedure: Single port laparoscopic appendectomy

3 port

Active Comparator group

Description:

3 port laparoscopic appendectomy was done by conventional method

Treatment:

Procedure: 3 port laparoscopic appendectomy