Prospective, Randomized Study of Single Port and Conventional Laparoscopic Appendectomy in Acute Appendicitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 194
- Locations
- 1
- Primary Endpoint
- Safety
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Single port laparoscopic appendectomy (Procedure)
3 port
3 port laparoscopic appendectomy was done by conventional method
Intervention: 3 port laparoscopic appendectomy (Procedure)
Outcomes
Primary Outcomes
Safety
Time Frame: 1 month
30 day morbidity and mortality
Secondary Outcomes
- Efficacy(7 days)
- Efficacy(1 day)
- Efficacy(2 days)
Investigators
Byung Mo Kang
Professor
Kyunghee University Medical Center