Appendicitis AcuteNCT06000020
Leave or Laparoscopic Appendectomy With Normal Findings - a Regional Cohort Study
An observational study of Appendicitis Acute, run by Nordsjaellands Hospital at 4 sites in Denmark.
Trial summary
Based on a regional cohort, this study we will try to demonstrate the superiority of routine laparoscopic appendectomy vs. leaving an intraoperative assessed normal appendix in situ in cases of normal findings at diagnostic laparoscopy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Appendicitis Acute
- What is being tested?
- Laparoscopic appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,435 participants
- Where
- 4 sitesDenmark
- Study dates
- 17 Mar 2017to 1 Apr 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing diagnostic laparoscopy on suspicion of acute appendicitis
Who may be able to join
- Diagnostic laparoscopy with normal intraoperative findings (including mesenteric adenitis
- Laparoscopic appendectomy and a histopathological normal appendix and otherwise normal intraoperative findings (including mesenteric adenitis)
Who cannot join
- Diagnostic laparoscopy with abnormal intraoperative findings.
- Laparoscopic appendectomy and a histopathological non-normal appendix.
- Laparoscopic appendectomy and a histopathological normal appendix and abnormal intraoperative findings.
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Copenhagen University Hospital - Bispebjerg
Copenhagen NV, 2400
Copenhagen University Hospital - Herlev
Herlev, 2730
Copenhagen University Hospital - North Zealand
Hillerød, 3400
Copenhagen University Hospital - Hvidovre
Hvidovre, 2650
About this study
Based on a regional cohort, this study we will try to demonstrate the superiority of routine laparoscopic appendectomy vs. leaving an intraoperative assessed normal appendix in situ in cases of normal findings at diagnostic laparoscopy. If routine laparoscopic appendectomy is not superior, we will recommend leaving the "normal" appendix in situ.
Read the detailed description
The study is a retrospective cohort study with a superiority design. It will be carried out at the surgical departments of the four public university hospitals providing emergency surgical service to the entire population of 1,8 million in the Capital Region of Denmark.
On March 17, 2017, a new electronic health record (EHR) had been implemented at three of the hospital, while it was implemented at Copenhagen University Hospital - Bispebjerg on May 20, 2017. These dates mark the start of the inclusion period for each hospital, while the inclusion period ended April 1, 2021 for all four hospitals.
The "snap boards" covering the relevant operation rooms at the four hospitals will be systematically review. For all cases, where diagnostic laparoscopy was performed on suspicion of acute appendicitis, the EHR will be reviewed.
- Conditions
- Appendicitis Acute
- Being tested
- Laparoscopic appendectomy
- Keywords
- Laparoscopic appendectomy, Normal findings
- 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
Laparoscopic appendectomy as performed as standard world wide. Division of the appendix with laparoscopic stapler.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic laparoscopy | Diagnostic laparoscopy on suspicion of acute appendicitis with normal intraoperative findings (including mesenteric adenitis). | |
| Laparoscopic appendectomy | Laparoscopic appendectomy despite normal intraoperative findings (including mesenteric adenitis) and histopathology showing a normal appendix. Receives: Procedure: Laparoscopic appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of surgery on suspicion of acute appendicitis
Laparoscopy or laparotomy after surgery on suspicion of acute appendicitis
Measured: 3 years
Risk of surgery on suspicion of acute appendicitis
Laparoscopy or laparotomy after surgery on suspicion of acute appendicitis
Measured: 5 years
Secondary outcomes (3)
Reintervention
Laparoscopy or laparotomy due to complications
Measured: 30 days
Postoperative complications
Postoperative complications according to the 'Clavien-Dindo classification'
Measured: 30 days
Length of stay
Time from index surgery to discharge
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start17 Mar 2017
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Appendicitis AcuteStudies 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
- Retrospective
- Enrolment
- 1,435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claus A Bertelsen, Ph.D., Study chair, cabertelsen@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000020
- Sponsor's protocol ID
- LapApp
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jaunoo SS, Hale AL, Masters JP, Jaunoo SR. An international survey of opinion regarding investigation of possible appendicitis and laparoscopic management of a macroscopically normal appendix. Ann R Coll Surg Engl. 2012 Oct;94(7):476-80. doi: 10.1308/003588412X13373405385377.
PubMed 23031764Di Saverio S, Birindelli A, Kelly MD, Catena F, Weber DG, Sartelli M, Sugrue M, De Moya M, Gomes CA, Bhangu A, Agresta F, Moore EE, Soreide K, Griffiths E, De Castro S, Kashuk J, Kluger Y, Leppaniemi A, Ansaloni L, Andersson M, Coccolini F, Coimbra R, Gurusamy KS, Campanile FC, Biffl W, Chiara O, Moore F, Peitzman AB, Fraga GP, Costa D, Maier RV, Rizoli S, Balogh ZJ, Bendinelli C, Cirocchi R, Tonini V, Piccinini A, Tugnoli G, Jovine E, Persiani R, Biondi A, Scalea T, Stahel P, Ivatury R, Velmahos G, Andersson R. WSES Jerusalem guidelines for diagnosis and treatment of acute appendicitis. World J Emerg Surg. 2016 Jul 18;11:34. doi: 10.1186/s13017-016-0090-5. eCollection 2016.
PubMed 27437029Bakker OJ, Go PM, Puylaert JB, Kazemier G, Heij HA; Werkgroep richtlijn Diagnostiek en behandeling van acute appendicitis. [Guideline on diagnosis and treatment of acute appendicitis: imaging prior to appendectomy is recommended]. Ned Tijdschr Geneeskd. 2010;154:A303. Dutch.
PubMed 21262032Lee M, Paavana T, Mazari F, Wilson TR. The morbidity of negative appendicectomy. Ann R Coll Surg Engl. 2014 Oct;96(7):517-20. doi: 10.1308/003588414X13946184903801.
PubMed 25245730Bijnen CL, Van Den Broek WT, Bijnen AB, De Ruiter P, Gouma DJ. Implications of removing a normal appendix. Dig Surg. 2003;20(2):115-21. doi: 10.1159/000069386.
PubMed 12686778Gough IR, Morris MI, Pertnikovs EI, Murray MR, Smith MB, Bestmann MS. Consequences of removal of a "normal" appendix. Med J Aust. 1983 Apr 16;1(8):370-2. doi: 10.5694/j.1326-5377.1983.tb99414.x.
PubMed 6835144Sorensen AK, Bang-Nielsen A, Levic-Souzani K, Pommergaard HC, Jorgensen AB, Tolstrup MB, Rud B, Kovacevic B, Bulut O. Readmission and reoperation rates following negative diagnostic laparoscopy for clinically suspected appendicitis: The "normal" appendix should not be removed - A retrospective cohort study. Int J Surg. 2019 Apr;64:1-4. doi: 10.1016/j.ijsu.2019.02.001. Epub 2019 Feb 12.
PubMed 30769215
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leave or Laparoscopic Appendectomy With Normal Findings - a Regional Cohort Study
- ClinicalTrials.gov ID
- NCT06000020
- Acronym / sponsor ID
- LapApp
- Conditions
- Appendicitis Acute
- Keywords
- Laparoscopic appendectomy, Normal findings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,435 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 21 Aug 2023 (actual)
- 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.
Based on a regional cohort, this study we will try to demonstrate the superiority of routine laparoscopic appendectomy vs. leaving an intraoperative assessed normal appendix in situ in cases of normal findings at diagnostic laparoscopy. If routine laparoscopic appendectomy is not superior, we will recommend leaving the "normal" appendix in situ.
Detailed description
The study is a retrospective cohort study with a superiority design. It will be carried out at the surgical departments of the four public university hospitals providing emergency surgical service to the entire population of 1,8 million in the Capital Region of Denmark.
On March 17, 2017, a new electronic health record (EHR) had been implemented at three of the hospital, while it was implemented at Copenhagen University Hospital - Bispebjerg on May 20, 2017. These dates mark the start of the inclusion period for each hospital, while the inclusion period ended April 1, 2021 for all four hospitals.
The "snap boards" covering the relevant operation rooms at the four hospitals will be systematically review. For all cases, where diagnostic laparoscopy was performed on suspicion of acute appendicitis, the EHR will be reviewed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnostic laparoscopy | – | –Diagnostic laparoscopy on suspicion of acute appendicitis with normal intraoperative findings (including mesenteric adenitis). |
| Laparoscopic appendectomy | – | Procedure: Laparoscopic appendectomyLaparoscopic appendectomy despite normal intraoperative findings (including mesenteric adenitis) and histopathology showing a normal appendix. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing diagnostic laparoscopy on suspicion of acute appendicitis
Key inclusion criteria (2 listed)
- Diagnostic laparoscopy with normal intraoperative findings (including mesenteric adenitis
- Laparoscopic appendectomy and a histopathological normal appendix and otherwise normal intraoperative findings (including mesenteric adenitis)
Key exclusion criteria (3 listed)
- Diagnostic laparoscopy with abnormal intraoperative findings.
- Laparoscopic appendectomy and a histopathological non-normal appendix.
- Laparoscopic appendectomy and a histopathological normal appendix and abnormal intraoperative findings.
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 appendectomyLaparoscopic appendectomy as performed as standard world wide. Division of the appendix with laparoscopic stapler. | Procedure or surgery | Laparoscopic appendectomy |
Primary outcome
Risk of surgery on suspicion of acute appendicitis
Time frame: 3 years
Laparoscopy or laparotomy after surgery on suspicion of acute appendicitis
Risk of surgery on suspicion of acute appendicitis
Time frame: 5 years
Laparoscopy or laparotomy after surgery on suspicion of acute appendicitis
3 secondary outcomes
Reintervention
Time frame: 30 days
Postoperative complications
Time frame: 30 days
Length of stay
Time frame: 30 days
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 10 Aug 2026.
- Background: PubMed 23031764Jaunoo SS, Hale AL, Masters JP, Jaunoo SR. An international survey of opinion regarding investigation of possible appendicitis and laparoscopic management of a macroscopically normal appendix. Ann R Coll Surg Engl. 2012 Oct;94(7):476-80. doi: 10.1308/003588412X13373405385377.
- Background: PubMed 27437029Di Saverio S, Birindelli A, Kelly MD, Catena F, Weber DG, Sartelli M, Sugrue M, De Moya M, Gomes CA, Bhangu A, Agresta F, Moore EE, Soreide K, Griffiths E, De Castro S, Kashuk J, Kluger Y, Leppaniemi A, Ansaloni L, Andersson M, Coccolini F, Coimbra R, Gurusamy KS, Campanile FC, Biffl W, Chiara O, Moore F, Peitzman AB, Fraga GP, Costa D, Maier RV, Rizoli S, Balogh ZJ, Bendinelli C, Cirocchi R, Tonini V, Piccinini A, Tugnoli G, Jovine E, Persiani R, Biondi A, Scalea T, Stahel P, Ivatury R, Velmahos G, Andersson R. WSES Jerusalem guidelines for diagnosis and treatment of acute appendicitis. World J Emerg Surg. 2016 Jul 18;11:34. doi: 10.1186/s13017-016-0090-5. eCollection 2016.
- Background: PubMed 21262032Bakker OJ, Go PM, Puylaert JB, Kazemier G, Heij HA; Werkgroep richtlijn Diagnostiek en behandeling van acute appendicitis. [Guideline on diagnosis and treatment of acute appendicitis: imaging prior to appendectomy is recommended]. Ned Tijdschr Geneeskd. 2010;154:A303. Dutch.
- Background: PubMed 25245730Lee M, Paavana T, Mazari F, Wilson TR. The morbidity of negative appendicectomy. Ann R Coll Surg Engl. 2014 Oct;96(7):517-20. doi: 10.1308/003588414X13946184903801.
- Background: PubMed 12686778Bijnen CL, Van Den Broek WT, Bijnen AB, De Ruiter P, Gouma DJ. Implications of removing a normal appendix. Dig Surg. 2003;20(2):115-21. doi: 10.1159/000069386.
- Background: PubMed 6835144Gough IR, Morris MI, Pertnikovs EI, Murray MR, Smith MB, Bestmann MS. Consequences of removal of a "normal" appendix. Med J Aust. 1983 Apr 16;1(8):370-2. doi: 10.5694/j.1326-5377.1983.tb99414.x.
- Background: PubMed 30769215Sorensen AK, Bang-Nielsen A, Levic-Souzani K, Pommergaard HC, Jorgensen AB, Tolstrup MB, Rud B, Kovacevic B, Bulut O. Readmission and reoperation rates following negative diagnostic laparoscopy for clinically suspected appendicitis: The "normal" appendix should not be removed - A retrospective cohort study. Int J Surg. 2019 Apr;64:1-4. doi: 10.1016/j.ijsu.2019.02.001. Epub 2019 Feb 12.
- Individual participant dataSharing planned: No
Related trials for Appendicitis Acute
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
Not yet recruitingPhase 2
Patient Choice Between Antibiotics and Appendectomy in Uncomplicated Appendicitis (FRENCH 47 - ALACARTE)
Acute Appendicitis
Active, not recruitingObservational study
Retrospective Acute Care Appendectomy Study
Acute Appendicitis
Not yet recruiting
Immediate Laparoscopic Appendectomy Versus Interval Laparoscopic Appendectomy for Early Appendicular Mass
Appendicular Mass, Acute Appendicitis
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.
Claus A Bertelsen, Ph.D. study chair
cabertelsen@gmail.com
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis Acute, run by Nordsjaellands Hospital at 4 sites in Denmark.
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 2 inclusion and 3 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. 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?
Risk of surgery on suspicion of acute appendicitis (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06000020, which also lists 7 linked publications.
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 10 Aug 2026.