Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001582145
Ethics application status
Not required
Date submitted
30/08/2019
Date registered
18/11/2019
Date last updated
18/11/2019
Date data sharing statement initially provided
18/11/2019
Date results information initially provided
18/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Drain or No Drain after thyroid surgery? A Retrospective Cohort Study
Scientific title
Drain or No Drain after thyroid surgery? A Retrospective Cohort Study
Secondary ID [1] 298044 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyroid surgery 312520 0
Condition category
Condition code
Metabolic and Endocrine 311072 311072 0 0
Thyroid disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
: This is a cohort study which conducted from 02/08/2016 to 02/02/2019. Patients files and notes were reviewed in a retrospective manner. The entire participants had undergone open surgery in the form of total or subtotal thyroidectomy or lobectomy or hemithyroidectomy for benign thyroid disorders. And had been already admitted and discharged from the wards of Al-Imam Al-Hussein medical city hospital/University of Kerbala/Faculty of Medicine/Kerbala/Iraq. The selection of entire participants was based on certain criteria. Those participants had been classified into two categories; drain and no drain categories. Drain category had drain inserted following the operation, while the no-drain category did not have drain following the operation. A comparison between both categories was done with regards to the following variables ;(i) the occurrence of post operative heamatoma (ii) the post operative seroma formation. (iii) The duration and expenses of in-patient ward admission. Statistical analysis was done using Pearson Chi-square test, Independent sample t test and Mann-Whitney U Test
Intervention code [1] 314290 0
Diagnosis / Prognosis
Comparator / control treatment
A comparison is made between the drain and no drain groups with regards to the following variables ;(i) the occurrence of post operative heamatoma (ii) the post operative seroma formation. (iii) The duration and expenses of in-patient ward admission. Statistical analysis was done using Pearson Chi-square test, Independent sample t test and Mann-Whitney U Test
Please note: the non drain group is the comparator
Control group
Active

Outcomes
Primary outcome [1] 319853 0
The occurrence of post-operative complications : hematoma and seroma. This is via the review of patients notes and files retrospectively
Timepoint [1] 319853 0
during the post-operative days
Secondary outcome [1] 375989 0
duration of hospital admission
Timepoint [1] 375989 0
post operative admission period
Secondary outcome [2] 375990 0
hospital expenses
Timepoint [2] 375990 0
pre and post operative days of admission

Eligibility
Key inclusion criteria
Participants had been enrolled in this study regardless of age, sex and race. This research included only the participants with almost similar parameters and care before, during and after the surgery so as to prevent any bias. This research included only the participants with specific inclusion criteria. These inclusion criteria were (i)benign thyroid disorders only (ii)total or subtotal thyroidectomy or lobectomy or hemithyroidectomy (iii) the indication of surgery was due to underactive thyroid or hyperactive thyroid or due to obstructive symptoms in terms of dysphagia or dyspnea (iv) open thyroid surgery (v)first time surgery (no history of previous thyroid surgery) (vi) all the patients should received proper thyroid disease assessment protocol in the form of proper history, physical examination and full investigations
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The research did not include patients with: (i) endoscopic thyroid surgery (ii) malignant thyroid disorders (iii) thyroid removed due to cosmetic appearance (iv) immunologically compromised patient such as diabetic patients or patients with AIDS or patients on long period steroid therapy or others (v) Patients with co-morbidities such as hypertension or blood disorders or patients with chronic use of anti-coagulants or antiplatelets. (vi) Patients who had their operations operated by inexpert surgeons. (vii) patients who had thyroid surgery before (revision surgery) (viii) very large goiter or very aggressive graves diseases with hyper-vascularity

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/08/2016
Date of last participant enrolment
Anticipated
Actual
2/01/2019
Date of last data collection
Anticipated
Actual
2/02/2019
Sample size
Target
267
Accrual to date
Final
233
Recruitment outside Australia
Country [1] 21433 0
Iraq
State/province [1] 21433 0
Kerbala

Funding & Sponsors
Funding source category [1] 302588 0
University
Name [1] 302588 0
University of Kerbala
Country [1] 302588 0
Iraq
Primary sponsor type
University
Name
University of Kerbala
Address
Iraq
Kerbala
Hay Almuathafeen
44 The university Stree
p o box 1225
Country
Iraq
Secondary sponsor category [1] 302481 0
None
Name [1] 302481 0
Address [1] 302481 0
Country [1] 302481 0

Ethics approval
Ethics application status
Not required

Summary
Brief summary
Aim of this current study was to assess effectiveness of post-operative drain in preventing or lowering the incidence of post-operative complications (hematoma and seroma) after thyroid surgery.
A comparison between both categories (drain/ no drain) was done with regards to the occurrence of post operative heamatoma , seroma , duration and expenses of in-patient ward admission
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). before the start of study at August 2016. 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 92882 0
Dr Ahmed Kamel Abdulhamid
Address 92882 0
Iraq/ Kerbala /Hay Almuathafeen/ Kerbala medical university/ department of surgery /44 The university street /p o box 1225
Country 92882 0
Iraq
Phone 92882 0
+964 7714 70 74 74
Fax 92882 0
Email 92882 0
[email protected]
Contact person for public queries
Name 92883 0
Dr Ahmed Kamel Abdulhamid
Address 92883 0
Iraq/ Kerbala /Hay Almuathafeen/ Kerbala medical university/ department of surgery /44 The university street /p o box 1225
Country 92883 0
Iraq
Phone 92883 0
+964 7714 70 74 74
Fax 92883 0
Email 92883 0
[email protected]
Contact person for scientific queries
Name 92884 0
Dr Ahmed Kamel Abdulhamid
Address 92884 0
Iraq/ Kerbala /Hay Almuathafeen/ Kerbala medical university/ department of surgery /44 The university street /p o box 1225
Country 92884 0
Iraq
Phone 92884 0
+964 7714 70 74 74
Fax 92884 0
Email 92884 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
the data is confidential between the patient, me and my statistical colleagues


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.