NCT04472052

Brief Summary

Appendicitis is one of the most common clinical conditions in general surgery. The diagnosis is usually made from clinical examination, imaging (sonography or CT) and laboratory parameters. The laparoscopic appendectomy without drainage has established as the gold standard. Patients usually leave the hospital two days after surgery. In times of corona crisis, patients are unsure to visit the hospital because of fear of infection with SARS-CoV-2. A higher incidence of perforated appendicitis could be an indicator for fear-related delay of going to the hospital. Methods: Investigators performed a retrospective analysis on the incidence of perforated appendicitis in a 10-week interval (mid-March to end of May) of the years 2018, 2019 and 2020 to evaluate possible changes in times of corona crisis. Intraoperative findings, procedures, complications and the length of hospital stay were considered.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

July 10, 2020

Last Update Submit

July 14, 2020

Conditions

Keywords

acute appendicitis, COVID-19

Outcome Measures

Primary Outcomes (1)

  • rate of perforated appendicitis

    10 weeks from 16th of March to 31th of May

Study Arms (1)

Appendectomy

Patients who required appendectomy for suspected acute appendicitis

Other: appendectomy

Interventions

Surgical standard treatment for acute appendicitis All patients receive preoperative single-shot antibiosis, usually 2000 mg cefotaxime combined 500 mg metronidazole. Appendectomy is performed usually within 24 h of admission in patients with acute appendicitis. The laparoscopic appendectomy using the 3-trocar technique represents the surgical standard. In uncomplicated or non-perforated appendicitis, drainage is generally not required. Wounds are closed intra-cutaneous with absorbable sutures. Patients without postoperative complications are discharged home two days after surgery.

Appendectomy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with acute appendicitis

You may qualify if:

  • patients with acute appendicitis older than 16 years
  • appendectomy in time frame 16th of march to 30th of May in the Years 2018, 2019 and 2020

You may not qualify if:

  • patients with acute appendicitis younger than 16 years
  • appendectomy not in the named time frames

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Tuebingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

AppendicitisCOVID-19

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 15, 2020

Study Start

March 16, 2020

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Researchers could send a request for the IPD to the investigators and will receive the required data.

Locations