Laparoscopic Versus Open Appendectomy

Acute Appendicitis Clinical Trial

Official title:

Laparoscopic vs. Open Surgical Procedure in Management of Acute Appendicitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967745
• Other study ID #: 01091981
• Status: Completed
• Phase: N/A
• First received: October 11, 2013
• Last updated: October 22, 2014
• Start date: January 2007
• Est. completion date: September 2013

Study information

• Verified date: October 2014
• Source: Varazdin General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Comparison of open and laparoscopic appendectomy

Description:

Adult patients with presumptive diagnosis of acute appendicitis were were operated by laparoscopic appendectomy or open appendectomy group during a three-year period (between 2007 and 2009).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients older than 16 years with presumptive diagnosis of acute appendicitis

Exclusion Criteria:Appendectomy performed during diagnostic laparoscopy and incidental appendectomies patients with:

• cirrhosis

• ascites

• coagulation disorder

• diffuse peritonitis

• shock on admission

• large ventral hernia. Appendectomy performed during diagnostic laparoscopy and incidental appendectomies were also excluded

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acute Appendicitis
• Acute Disease
• Appendicitis

Intervention

Procedure:
• laparoscopic appendectomy
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.
• open appendectomy
The open appendectomy was carried out in the standard way with McBurney muscle splitting incision (in supine position).

Locations

Country	Name	City	State
Croatia	Varazdin General Hospital	Varazdin

Sponsors (1)

Lead Sponsor	Collaborator
Varazdin General Hospital

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Analgesia demands	The number of doses of analgesics, and time from surgery to the last dose of analgesics.	from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)	No
Secondary	Complications	No. of wound infection and intrabdominal abscesses.	during first 4 weeks after the surgery	No
Secondary	Length of hospital stay	No. of days from surgery to discharge of hospital	from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)	No
Secondary	Time until resumption of clear liquid and regular diet	No. of days from surgery to the resumption of clear liquid and regular diet	from the beginning of the surgery to the resumption (an expected average 2 days after the surgery)	No