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NCT01348464 Clinical Trial

A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy

Acute Appendicitis Clinical Trial

Official title:
Transumbilical Single Port Laparoscopic Appendectomy Versus Conventional Laparoscopic Appendectomy in Adult Patients: A Prospective Randomized Control Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01348464
Other study ID # girba2339
Secondary ID
Status Completed
Phase N/A
First received April 29, 2011
Last updated April 2, 2012
Start date March 2010
Est. completion date December 2011

Study information
Verified date April 2012
Source Gachon University Gil Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

The aim of this study is to compare patients who undergone single-port access laparoscopic appendectomy to those who underwent conventional three-port laparoscopic appendectomy (TPLA) in a prospective randomized trial

Description:

- primary objective

1. complication rate

- secondary objectives

1. satisfaction rate

2. pain scale difference

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date December 2011
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 85 Years
Eligibility Inclusion Criteria:

- age 5~85 years

- any patient diagnosed with acute appendicitis on appendix sonography or abdominopelvic CT

- Patient performance status(PS) with greater than 80 or more on Karnofsky PS

- Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

Exclusion Criteria:

- Pregnant or lactating

- Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease

- History of Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently treated cancer

- Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• single port appendectomy, three port appendectomy
visual analog scale. questionnaire on wound satisfaction

Locations
Country Name City State
Korea, Republic of Gachon Univ., Gil Medical Center Incheon

Sponsors (1)
Lead Sponsor Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Raakow R, Jacob DA. Initial experience in laparoscopic single-port appendectomy: a pilot study. Dig Surg. 2011;28(1):74-9. doi: 10.1159/000322921. Epub 2011 Feb 4. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Complication rate observe complication caused by both procedures participants will be followed for the duration of hospital stay, an expected average of 24 weeks No
Secondary patient satisfaction Questionarire is given to the patients on postoperative 3days, 1month, 3 months and 6 months participants will be followed for the duration of hospital stay, an expected average of 24 weeks No
See also
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Completed NCT04649996 - Variation in Acute Appendicitis During COVID-19 Pandemic in Italy
Completed NCT04030741 - Non-operative Treatment of Acute Non-perforated Appendicitis Phase 2/Phase 3
Recruiting NCT04860570 - Are Double-ring Wound-edge Protectors Effective for Preventing Superficial Surgical Site Infection After Open Appendectomy?
Withdrawn NCT05724628 - Non-operative vs. Operative Management of Acute Appendicitis in Vulnerable Patient Populations Phase 1
Completed NCT01024439 - Transumbilical Single Incision Versus Conventional Three Incisions Laparoscopic Appendicectomy N/A
Completed NCT02714023 - Water And Saline Head-to-head In The Blinded Evaluation Study Trial N/A
Active, not recruiting NCT03324165 - Comparing Proposed Algorithm and Current Practice in the Evaluation of Suspected Appendicitis N/A
Active, not recruiting NCT01022567 - Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis N/A
Not yet recruiting NCT06059365 - Clinical Trial for a Outpatient Clinical Management for Complicated Acute Appendicitis N/A
Not yet recruiting NCT06051825 - Diagnostic Importance of the C-reactive Protein From Blood and Saliva in Children With Acute Appendicitis
Recruiting NCT04947748 - Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous N/A
Terminated NCT04207645 - Modification and Validation of the RIPASA Score for Diagnosis of Acute Appendicitis
Completed NCT04615728 - MANAGEMENT OF APPENDICITIS DURING THE COVID-19 PANDEMIC
Not yet recruiting NCT02789865 - Clinical Trial Comparing ERAT vs Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis Phase 2
Completed NCT02731924 - Point of Care Ultrasound for Evaluation of Suspected Appendicitis in the Emergency Department
Completed NCT05104346 - Presentation and Outcomes of Acute Appendicitis During COVID Pandemic N/A
Completed NCT03886896 - Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy Phase 4
Not yet recruiting NCT01720082 - Laparoscopic Appendectomy by Multi-port vs Single Port. Phase 3

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