AppendicitisNCT05315869
a Retrospective Observational Study Comparing Outcomes of Retrocaecal Appendicitis With Non-retrocaecal Appendicitis
An observational study of Appendicitis and Appendicitis Acute, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
Trial summary
A retrospective observational study investigating whether retrocecal appendicitis associated with worse operative and postoperative outcomes than non-retrocecal appendicitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis, Appendicitis Acute, Retrocecal Appendicitis
- What is being tested?
- Appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 754 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2015to 1 May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients of the treated at the department of surgery of the University Hospital Kralovske Vinohrady
Who may be able to join
- All patients undergoing surgery for signs of acute appendicitis at the department of surgery of the University Hospital Kralovske Vinohrady between January 2015 to April 2020
Who cannot join
- Patients under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrocaecal Appendicitis: Risk Factor for Perioperative Complications?
A retrospective observational study investigating whether retrocecal appendicitis associated with worse operative and postoperative outcomes than non-retrocecal appendicitis.
Read the detailed description
Acute appendicitis is the most common cause of acute abdomen requiring acute surgery. The prevalence of the retrocaecal position of the appendix varies significantly between studies from 14 to 36%. Appendectomy of a retrocecal appendix is generally considered to be more demanding procedure than appendectomy of appendices in other positions. The aim of this study is to investigate whether retrocaecal appendicitis is associated with a higher rate of perioperative complications and delayed diagnosis when compared with the other positions.
A retrospective analysis of prospectively collected data of patients undergoing surgery for signs of acute appendicitis from January 2015 to April 2020 at the University Hospital Kralovske Vinohrady. Two groups of patients were be formed: the retrocaecal group and the non-retrocaecal group.
The following data were recorded: sex, age, body mass index, length of hospital stay, abdominal drain placement, length of surgery, surgical approach (laparoscopic, open or converted), operative finding (normal appendix or catarrhal, phlegmonous, gangrenous, or perforated appendicitis), position of the appendix (retrocaecal or non-retrocaecal positions), histopathological findings (acute inflammation, chronic inflammation, appendiceal tumour or normal appendix), 30-day postoperative complications, 30-day postoperative mortality, symptoms (abdominal pain, nausea, vomiting, diarrhoea, body temperature above 37 degrees celsius, urological complaints and gynaecological complaints), duration of symptoms (from onset to surgery), serious comorbidities and diabetes mellitus.
- Conditions
- Appendicitis, Appendicitis Acute, Retrocecal Appendicitis
- Being tested
- Appendectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppendectomyProcedure or surgery
Surgical procedure for removal of the appendix
| Study group | Role | What they receive |
|---|---|---|
| Retrocaecal group | Patients who underwent surgery for signs of acute appendicitis and had intraoperative finding of the appendix located in the retrocaecal position. Receives: Procedure: Appendectomy | |
| Non-retrocaecal group | Patients who underwent surgery for signs of acute appendicitis and had intraoperative finding of the appendix not located in the retrocaecal position. Receives: Procedure: Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient with postoperative complications
surgical site infections, postoperative ileus, bleeding, internal complications,
Measured: 30 days after intervention (appendectomy)
Number of patient who undergo converted appendectomy
Conversion from laparoscopic to open appendectomy
Measured: during the surgery
Length of hospital stay
Length of hospital stay after the procedure in days
Measured: 30 days after intervention (appendectomy)
Duration of procedure
Duration of appendectomy in minutes
Measured: Throughout the study period (1/2015-4/2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Jan 2015
- Primary completion1 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 754 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Adam Whitley, Faculty Hospital Kralovske Vinohrady
- Investigators
- Adam Whitley, MUDr., Study chair, Vascular surgery, University hospital Královské Vinohrady, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315869
- Sponsor's protocol ID
- AppendicitisFNKV
- Status last verified
- Mar 2022
- First submitted
- 20 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrocaecal Appendicitis: Risk Factor for Perioperative Complications?
- ClinicalTrials.gov ID
- NCT05315869
- Acronym / sponsor ID
- AppendicitisFNKV
- Conditions
- Appendicitis, Appendicitis Acute, Retrocecal Appendicitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 754 participants (actual)
- Lead sponsor
- Faculty Hospital Kralovske VinohradyOther government
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 7 Apr 2022 (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.
A retrospective observational study investigating whether retrocecal appendicitis associated with worse operative and postoperative outcomes than non-retrocecal appendicitis.
Detailed description
Acute appendicitis is the most common cause of acute abdomen requiring acute surgery. The prevalence of the retrocaecal position of the appendix varies significantly between studies from 14 to 36%. Appendectomy of a retrocecal appendix is generally considered to be more demanding procedure than appendectomy of appendices in other positions. The aim of this study is to investigate whether retrocaecal appendicitis is associated with a higher rate of perioperative complications and delayed diagnosis when compared with the other positions.
A retrospective analysis of prospectively collected data of patients undergoing surgery for signs of acute appendicitis from January 2015 to April 2020 at the University Hospital Kralovske Vinohrady. Two groups of patients were be formed: the retrocaecal group and the non-retrocaecal group.
The following data were recorded: sex, age, body mass index, length of hospital stay, abdominal drain placement, length of surgery, surgical approach (laparoscopic, open or converted), operative finding (normal appendix or catarrhal, phlegmonous, gangrenous, or perforated appendicitis), position of the appendix (retrocaecal or non-retrocaecal positions), histopathological findings (acute inflammation, chronic inflammation, appendiceal tumour or normal appendix), 30-day postoperative complications, 30-day postoperative mortality, symptoms (abdominal pain, nausea, vomiting, diarrhoea, body temperature above 37 degrees celsius, urological complaints and gynaecological complaints), duration of symptoms (from onset to surgery), serious comorbidities and diabetes mellitus.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrocaecal group | – | Procedure: AppendectomyPatients who underwent surgery for signs of acute appendicitis and had intraoperative finding of the appendix located in the retrocaecal position. |
| Non-retrocaecal group | – | Procedure: AppendectomyPatients who underwent surgery for signs of acute appendicitis and had intraoperative finding of the appendix not located in the retrocaecal position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients of the treated at the department of surgery of the University Hospital Kralovske Vinohrady
Key inclusion criteria (1 listed)
- All patients undergoing surgery for signs of acute appendicitis at the department of surgery of the University Hospital Kralovske Vinohrady between January 2015 to April 2020
Key exclusion criteria (1 listed)
- Patients under 18 years of age
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 |
|---|---|---|
| AppendectomySurgical procedure for removal of the appendix | Procedure or surgery | Non-retrocaecal group, Retrocaecal group |
Primary outcome
Number of patient with postoperative complications
Time frame: 30 days after intervention (appendectomy)
surgical site infections, postoperative ileus, bleeding, internal complications,
Number of patient who undergo converted appendectomy
Time frame: during the surgery
Conversion from laparoscopic to open appendectomy
Length of hospital stay
Time frame: 30 days after intervention (appendectomy)
Length of hospital stay after the procedure in days
Duration of procedure
Time frame: Throughout the study period (1/2015-4/2020)
Duration of appendectomy in minutes
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 7 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
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PAINED: Project Addressing INequities in the Emergency Department
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Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
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RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
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.
Adam Whitley, MUDr. study chair
Vascular surgery, University hospital Královské Vinohrady, Prague
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 Appendicitis and Appendicitis Acute, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
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 1 inclusion and 1 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 7 Apr 2022. 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 Czechia. 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?
Number of patient with postoperative complications (time frame: 30 days after intervention (appendectomy)). The study lists 4 primary outcomes in all. 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 7 Apr 2022.