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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01007318
Other study ID # khnmc IRB 2009-026
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT04365491 - European Society for Trauma and Emergency Surgery (ESTES) Cohort Study Snapshot Audit 2020 - Acute Appendicitis
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Active, not recruiting NCT01718275 - Non-operative Management of Early Appendicitis in Children
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