NCT04163211

Brief Summary

The investigators performed a retrospective review of all patients undergoing appendicectomy from March-November 2018 using the online theatre database and discharge letters. CA was defined as patients with perforated or gangrenous appendicitis on histology. Patients were divided into 2 groups; Group 1 (G1) included patients with CA who had a drain inserted; Group 2 (G2) included patients with CA and no drain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

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 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

8 months

First QC Date

November 11, 2019

Last Update Submit

November 19, 2019

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

  • Intra-abdominal abscess

    Up to 6 months post-operative

Secondary Outcomes (1)

  • Length of stay

    8 months - March to November 2018

Study Arms (2)

Group 1

Patients with complicated appendicitis who had a drain inserted

Procedure: Abdominal drain

Group 2

Patients with complicated appendicitis who did not have a drain inserted

Procedure: Abdominal drain

Interventions

Abdominal drainPROCEDURE

A latex-free drain (size 20F)

Group 1Group 2

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients over the age of 16 with complicated appendicitis (CA) were included. CA was defined as histologically proven gangrenous or perforated appendicitis.

You may qualify if:

  • All patients over the age of 16 with complicated appendicitis (CA) were included

You may not qualify if:

  • Patients with evidence of caecal/ appendicular malignancy were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Whittington Hospital NHS Trust

London, N19 5NF, United Kingdom

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2019

First Posted

November 14, 2019

Study Start

March 1, 2018

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

November 22, 2019

Record last verified: 2019-11

Locations

GB(1)