Safety and Efficacy Study of Single Port Laparoscopic Appendectomy in Acute Appendicitis
Prospective, Randomized Study of Single Port and Conventional Laparoscopic Appendectomy in Acute Appendicitis
1 other identifier
interventional
194
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2009
CompletedFirst Posted
Study publicly available on registry
November 4, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedSeptember 7, 2020
September 1, 2020
1 year
November 3, 2009
September 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Safety
30 day morbidity and mortality
1 month
Secondary Outcomes (5)
Efficacy
1 day
Efficacy
2 days
Efficacy
2 days
Efficacy
7 days
Efficacy
7 days
Study Arms (2)
Single port
ACTIVE COMPARATORSingle 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
ACTIVE COMPARATOR3 port laparoscopic appendectomy was done by conventional method
Interventions
Single port through the transumbilical 2-cm incision
3 trocars was inserted in infraumbilical, left lower quadrant, and suprapubic area
Eligibility Criteria
You may qualify if:
- Clinically diagnosed acute appendicitis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyung Hee University School of Medicine, Neo Medical Center
Seoul, 134-727, South Korea
Related Publications (1)
Kang BM, Choi SI, Kim BS, Lee SH. Single-port laparoscopic surgery in uncomplicated acute appendicitis: a randomized controlled trial. Surg Endosc. 2018 Jul;32(7):3131-3137. doi: 10.1007/s00464-018-6028-0. Epub 2018 Jan 16.
PMID: 29340826DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suk Hwan Lee, MD. PhD
Kyung Hee University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 3, 2009
First Posted
November 4, 2009
Study Start
December 1, 2009
Primary Completion
December 1, 2010
Study Completion
February 1, 2016
Last Updated
September 7, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share