The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000995279
Ethics application status
Not required
Date submitted
5/06/2018
Date registered
14/06/2018
Date last updated
14/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is abdominal drainage after open emergency appendectomy for complicated appendicitis beneficial or waste of money? A retrospective cohort study
Scientific title
Is abdominal drainage after open emergency appendectomy for complicated appendicitis beneficial or waste of money? A retrospective cohort study
Secondary ID [1] 295108 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
complicated appendicitis (perforated appendicitis with localized abscess formation ) 308211 0
Condition category
Condition code
Surgery 307219 307219 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this retrospective cohort study, files and notes were reviewed for patients who had open emergency appendectomy for complicated appendicitis (perforated appendicitis with localized abscess formation only) and who had already been discharged from surgical wards of our institution (Kerbala medical university / Imam Hussein medical city hospital/ Kerbala/Iraq). Data regarding insertion of intra-abdominal drain, length and cost of hospital stay were collected from hospital records. Patients were retrospectively followed up for two months to collect data on post-operative complications (intra-peritoneal abscess and wound infection) and mortality outcome. Statistical analysis was done using Pearson Chi-square test, Independent sample t test and Mann-Whitney U Test
Intervention code [1] 301454 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306194 0
The rate of post-operative intra-peritoneal abscess and wound infection assessed by medical record audit
Timepoint [1] 306194 0
The patients had been followed up to a period of 2 months post-operatively
Secondary outcome [1] 347813 0
The length of hospital stay and the cost of operation and hospital stay
Timepoint [1] 347813 0
7-10 days post-operatively

Eligibility
Key inclusion criteria
The patients who had open emergency appendectomy for complicated appendicitis were included in this research irrespective of their age, gender and race. The study included the patients who had perforated appendicitis with localized abscess formation only. All participants received the same course (type, dose, route of administration and duration) of antibiotics pre and post operatively. All the included patients had the same level of pre, intra and post-operative care. All these information had been taken from patients files retrospectively.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The study excluded the following participants: (i) patients with uncomplicated appendicitis (ii) patients with other forms of complicated appendicitis such as gangrenous appendicitis, perforated appendicitis without abscess formation , periappendiceal sub-acute inflammation or others (iii) patients with laparoscopic appendectomy (iv) patients for whom other methods for preventing post-operative surgical site infection ,such as different course of antibiotics or delay wound closure etc, applied (v) immune-compromised patients such as DM, HIV or long term steroid therapy (vi)patients who received the same course of antibiotics but had antibiotics resistance due to previous exposure. This was obtained from past drug history. (vii) Patients who had a different type or level of pre, intra and post operative care.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10531 0
Iraq
State/province [1] 10531 0
Kerbala

Funding & Sponsors
Funding source category [1] 299711 0
University
Name [1] 299711 0
Kerbala Medical University
Address [1] 299711 0
Iraq
Kerbala
Hay Almuathafeen
44 The university Stree
p o box 1225
Country [1] 299711 0
Iraq
Primary sponsor type
University
Name
Kerbala Medical university
Address
Iraq
Kerbala
Hay Almuathafeen
44 The university Stree
p o box 1225
Country
Iraq
Secondary sponsor category [1] 299029 0
None
Name [1] 299029 0
Address [1] 299029 0
Country [1] 299029 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 300592 0
Ethics committee address [1] 300592 0
Ethics committee country [1] 300592 0
Date submitted for ethics approval [1] 300592 0
Approval date [1] 300592 0
Ethics approval number [1] 300592 0

Summary
Brief summary
It was a retrospective cohort study which reviewed files and notes of the patients who had open emergency appendectomy for complicated appendicitis and who have been already admitted and discharged from surgical wards of our institution (Kerbala medical university / Imam Hussein medical city hospital/ Kerbala/Iraq). This institution is a university hospital and a recognized centre for undergraduate and postgraduate medical studies. The permission and approval for the research was taken from the university. Patients were contacted via phone for their consent for the study and for follow up if they were alive.
Trial website
Trial related presentations / publications
Public notes
The permission and approval for the research was taken from the university ( (Kerbala medical university / Imam Hussein medical city hospital/ Kerbala/Iraq). Patients were contacted via phone for their consent for the study. According to rules in our country this can replace the ethical approval. The approval was moral approval

Contacts
Principal investigator
Name 84146 0
Dr Ahmed Kamel Abbdulhamid
Address 84146 0
Iraq
Kerbala
Hay Almuathafeen
Kerbala medical university
department of surgery
44 The university street
p o box 1225
Country 84146 0
Iraq
Phone 84146 0
+964 7714 70 74 74
Fax 84146 0
Email 84146 0
dectorahmed@yahoo.com
Contact person for public queries
Name 84147 0
Dr Ahmed Kamel Abbdulhamid
Address 84147 0
Iraq
Kerbala
Hay Almuathafeen
Kerbala medical university
department of surgery
44 The university street
p o box 1225
Country 84147 0
Iraq
Phone 84147 0
+964 7714 70 74 74
Fax 84147 0
Email 84147 0
dectorahmed@yahoo.com
Contact person for scientific queries
Name 84148 0
Dr Ahmed Kamel Abbdulhamid
Address 84148 0
Iraq
Kerbala
Hay Almuathafeen
Kerbala medical university
department of surgery
44 The university street
p o box 1225
Country 84148 0
Iraq
Phone 84148 0
+964 7714 70 74 74
Fax 84148 0
Email 84148 0
dectorahmed@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary