AppendicitisNCT04163211
Abdominal Drainage During Appendicectomy - Resources Down the Drain: A Retrospective Cohort Study
An observational study of Appendicitis, run by The Whittington Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Appendicitis
- What is being tested?
- Abdominal drain
- Type of treatment
- Surgery or procedure
- How many people
- 76 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2018to 1 Nov 2018
- 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 16 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- All patients over the age of 16 with complicated appendicitis (CA) were included
Who cannot join
- Patients with evidence of caecal/ appendicular malignancy were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Appendicitis
- Being tested
- Abdominal drain
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal drainProcedure or surgery
A latex-free drain (size 20F)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with complicated appendicitis who had a drain inserted Receives: Procedure: Abdominal drain | |
| Group 2 | Patients with complicated appendicitis who did not have a drain inserted Receives: Procedure: Abdominal drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-abdominal abscess
Measured: Up to 6 months post-operative
Secondary outcomes (1)
Length of stay
Number of days patient in hospital since admission
Measured: 8 months - March to November 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start1 Mar 2018
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Whittington Hospital NHS Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Scarlet Nazarian, The Whittington Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163211
- Sponsor's protocol ID
- 12345678
- Status last verified
- Nov 2019
- First submitted
- 11 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Individual data sharing
- Undecided: Anonymised data if appropriate with permission of the Trust
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Drainage During Appendicectomy - Resources Down the Drain: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04163211
- Acronym / sponsor ID
- 12345678
- Conditions
- Appendicitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- The Whittington Hospital NHS TrustOther government
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 14 Nov 2019 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Abdominal drainPatients with complicated appendicitis who had a drain inserted |
| Group 2 | – | Procedure: Abdominal drainPatients with complicated appendicitis who did not have a drain inserted |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients over the age of 16 with complicated appendicitis (CA) were included
Key exclusion criteria (1 listed)
- Patients with evidence of caecal/ appendicular malignancy were excluded.
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 |
|---|---|---|
| Abdominal drainA latex-free drain (size 20F) | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Intra-abdominal abscess
Time frame: Up to 6 months post-operative
1 secondary outcome
Length of stay
Time frame: 8 months - March to November 2018
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 22 Nov 2019.
- Individual participant dataSharing planned: Undecided. Anonymised data if appropriate with permission of the Trust
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
Not yet recruitingPhase 3
Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
Appendicitis Perforated, Appendectomy, Laparoscopic
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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by The Whittington Hospital NHS Trust at 1 site in United Kingdom.
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 22 Nov 2019. 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 United Kingdom. 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?
Intra-abdominal abscess (time frame: Up to 6 months post-operative). 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 22 Nov 2019.