- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05315869
a Retrospective Observational Study Comparing Outcomes of Retrocaecal Appendicitis With Non-retrocaecal Appendicitis
Retrocaecal Appendicitis: Risk Factor for Perioperative Complications?
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Prague
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Praha 3, Prague, Czechia, 13000
- Adam Whitley
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients under 18 years of age
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Retrocaecal group
Patients who underwent surgery for signs of acute appendicitis and had intraoperative finding of the appendix located in the retrocaecal position.
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Surgical procedure for removal of the appendix
|
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.
|
Surgical procedure for removal of the appendix
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patient with postoperative complications
Time Frame: 30 days after intervention (appendectomy)
|
surgical site infections, postoperative ileus, bleeding, internal complications,
|
30 days after intervention (appendectomy)
|
Number of patient who undergo converted appendectomy
Time Frame: during the surgery
|
Conversion from laparoscopic to open appendectomy
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during the surgery
|
Length of hospital stay
Time Frame: 30 days after intervention (appendectomy)
|
Length of hospital stay after the procedure in days
|
30 days after intervention (appendectomy)
|
Duration of procedure
Time Frame: Throughout the study period (1/2015-4/2020)
|
Duration of appendectomy in minutes
|
Throughout the study period (1/2015-4/2020)
|
Collaborators and Investigators
Investigators
- Study Chair: Adam Whitley, MUDr., University Hospital Kralovske Vinohrady
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AppendicitisFNKV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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