Laparoscopic Versus Open Appendectomy
Laparoscopic vs. Open Surgical Procedure in Management of Acute Appendicitis
1 other identifier
observational
100
1 country
1
Brief Summary
Comparison of open and laparoscopic appendectomy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2007
Longer than P75 for all trials
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
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 11, 2013
CompletedFirst Posted
Study publicly available on registry
October 23, 2013
CompletedOctober 24, 2014
October 1, 2014
2.9 years
October 11, 2013
October 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cost of hospitalization based on the final hospital bills
from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)
Secondary Outcomes (4)
Analgesia demands
from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)
Complications
during first 4 weeks after the surgery
Length of hospital stay
from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)
Time until resumption of clear liquid and regular diet
from the beginning of the surgery to the resumption (an expected average 2 days after the surgery)
Study Arms (2)
laparoscopic appendectomy
The laparoscopic appendectomy was performed with three trocars, placed in the periumbilical area, right midabdomen, and forceps.
open appendectomy
The open appendectomy was carried out in the standard way with McBurney muscle splitting incision (in supine position).
Interventions
The laparoscopic appendectomy was performed with three trocars. Pneumoperitoneum was created using an open Hasson technique. The mesoappendix was divided using a harmonic scalpel or endoscopic tissue fusion device. The appendix was divided by placing one endoscopic loop and cut with harmonic scalpel. The specimen was removed through the umbilical port.
The open appendectomy was carried out in the standard way with McBurney muscle splitting incision (in supine position).
Eligibility Criteria
Adult patients with clinical, laboratory, and radiologic signs of acute appendicitis
You may qualify if:
- patients older than 16 years with presumptive diagnosis of acute appendicitis
You may not qualify if:
- cirrhosis
- ascites
- coagulation disorder
- diffuse peritonitis
- shock on admission
- large ventral hernia. Appendectomy performed during diagnostic laparoscopy and incidental appendectomies were also excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Varazdin General Hospital
Varaždin, 42000, Croatia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ranko Stare, MD, PhD
Varazdin General Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2013
First Posted
October 23, 2013
Study Start
January 1, 2007
Primary Completion
December 1, 2009
Study Completion
September 1, 2013
Last Updated
October 24, 2014
Record last verified: 2014-10