Abdominal Drainage During Appendicectomy - Resources Down... | NCT04163211

Studies
Abdominal Drainage During Appendicectomy - Resources Down the Drain: A Retrospective Cohort Study

NCT04163211

Sponsor

The Whittington Hospital NHS Trust

Status

Completed

Last Update Posted

Nov 22, 2019Actual

Enrollment

76Actual

Phase

Not provided

Conditions

Appendicitis

Interventions

Abdominal drain

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2018Actual

Primary Completion Date

Nov 1, 2018Actual

Completion Date

Nov 1, 2018Actual

First Submitted Date

Nov 11, 2019

First Submission Date that Met QC Criteria

Nov 13, 2019

First Posted Date

Nov 14, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2019

Last Update Posted Date

Nov 22, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Scarlet Nazarian, Principal Investigator, The Whittington Hospital NHS TrustPrincipal Investigator

Lead Sponsor

The Whittington Hospital NHS TrustOTHER_GOV

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Abdominal drain	Procedure	A latex-free drain (size 20F)	Group 1 Group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intra-abdominal abscess		Up to 6 months post-operative

Secondary Outcomes

Measure	Description	Time Frame
Length of stay	Number of days patient in hospital since admission	8 months - March to November 2018

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients with evidence of caecal/ appendicular malignancy were excluded.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Whittington Hospital NHS Trust		London		N19 5NF	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Anonymised data if appropriate with permission of the Trust

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001064	Appendicitis

Ancestor Terms

ID	Term
D059413	Intraabdominal Infections
D007239	Infections
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided