Acute AppendicitisNCT01967745
Laparoscopic Versus Open Appendectomy
An observational study of Acute Appendicitis, run by Varazdin General Hospital at 1 site in Croatia.
Trial summary
Comparison of open and laparoscopic appendectomy Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- laparoscopic appendectomy and open appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- Jan 2007to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients with clinical, laboratory, and radiologic signs of acute appendicitis
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic vs. Open Surgical Procedure in Management of Acute Appendicitis
Comparison of open and laparoscopic appendectomy
Read the detailed 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).
- Conditions
- Acute Appendicitis
- Being tested
- laparoscopic appendectomy, open appendectomy
- Keywords
- open appendectomy, laparoscopic appendectomy, appendicitis
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic appendectomyProcedure or surgery
Also called harmonic scalpel (UltraCision Ethicon ®), fusion device (Covidien LigaSure™), stapling device (Covidien Endo GIA™)
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 appendectomyProcedure or surgery
The open appendectomy was carried out in the standard way with McBurney muscle splitting incision (in supine position).
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic appendectomy | The laparoscopic appendectomy was performed with three trocars, placed in the periumbilical area, right midabdomen, and forceps. Receives: Procedure: laparoscopic appendectomy | |
| open appendectomy | The open appendectomy was carried out in the standard way with McBurney muscle splitting incision (in supine position). Receives: Procedure: open appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of hospitalization based on the final hospital bills
Measured: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)
Secondary outcomes (4)
Analgesia demands
The number of doses of analgesics, and time from surgery to the last dose of analgesics.
Measured: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)
Complications
No. of wound infection and intrabdominal abscesses.
Measured: during first 4 weeks after the surgery
Length of hospital stay
No. of days from surgery to discharge of hospital
Measured: 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
No. of days from surgery to the resumption of clear liquid and regular diet
Measured: from the beginning of the surgery to the resumption (an expected average 2 days after the surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startJan 2007
- Primary completionDec 2009
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Varazdin General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ranko Stare, MD, PhD, Principal investigator, Varazdin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967745
- Sponsor's protocol ID
- 01091981
- Status last verified
- Oct 2014
- First submitted
- 11 Oct 2013
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic vs. Open Surgical Procedure in Management of Acute Appendicitis
- ClinicalTrials.gov ID
- NCT01967745
- Acronym / sponsor ID
- 01091981
- Conditions
- Acute Appendicitis
- Keywords
- open appendectomy, laparoscopic appendectomy, appendicitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Varazdin General HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 23 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of open and laparoscopic appendectomy
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic appendectomy | – | Procedure: laparoscopic appendectomyThe laparoscopic appendectomy was performed with three trocars, placed in the periumbilical area, right midabdomen, and forceps. |
| open appendectomy | – | Procedure: open appendectomyThe open appendectomy was carried out in the standard way with McBurney muscle splitting incision (in supine position). |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients with clinical, laboratory, and radiologic signs of acute appendicitis
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic appendectomyAlso: harmonic scalpel (UltraCision Ethicon ®), fusion device (Covidien LigaSure™), stapling device (Covidien Endo GIA™)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. | Procedure or surgery | laparoscopic appendectomy |
| open appendectomyThe open appendectomy was carried out in the standard way with McBurney muscle splitting incision (in supine position). | Procedure or surgery | open appendectomy |
Primary outcome
Cost of hospitalization based on the final hospital bills
Time frame: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)
4 secondary outcomes
Analgesia demands
Time frame: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)
Complications
Time frame: during first 4 weeks after the surgery
Length of hospital stay
Time frame: 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
Time frame: from the beginning of the surgery to the resumption (an expected average 2 days after the surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ranko Stare, MD, PhD principal investigator
Varazdin General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis, run by Varazdin General Hospital at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost of hospitalization based on the final hospital bills (time frame: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2014; AzTrials last refreshed its copy on 28 Oct 2026.