Drain or no Drain After Thyroid Surgery: a Randomized Clinical Trial at Mulago Hospital

Study Overview
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Brief Summary
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Thyroidectomy is one of the most commonly performed operations in general surgery. Available data seem to suggest an association between no-drain usage and a shorter duration of hospital stay. Seung et al found that the (following thyroidectomy) time to discharge after thyroidectomy was significantly shorter in the no drain group compared to the drain group. Similar results were recorded in a study conducted by Davari et al. Hyoung et al reported the incidence of hematoma formation post- thyroidectomy to be varying between 0.3%-4.3%. Tahsin et al reported that post-thyroidectomy bleeding is as rare as 0.3%-1.0%. The fear of an hematoma enlarging and obstructing the airway and causing difficulty in breathing, prompts many surgeons to use drains routinely after any type of thyroid surgery. The main reason is to drain off a possible postoperative hemorrhage, which may compress the airway and produce respiratory fail

Detailed Description
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This study will be aimed at comparing the patient outcomes with drain and no-drain insertion methods after thyroidectomy in a resource limited setting. Study population: All adult patients aged between 18 to 79 years who attended the endocrinology outpatient clinic and had been diagnosed with goiter. Study Participants: All adult patients with goiters who were eligible for thyroidectomy Inclusion criteria: All adult patients aged between 18 to 79 years with a diagnosis of goiter who consented to participate in the study. Exclusion criteria: The investigators excluded patients with goiter who had a history suggestive of bleeding tendencies, recurrent goiter, and thyroid cancer with fixation of the thyroid gland to surrounding structures and had uncontrolled co-morbidities such as diabetes mellitus (DM) and hypertension (HT). Inserting a drain after goiter surgery and not inserting a drain is the intervention all participants receive the same treatment

Official Title
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Drain or no Drain After Thyroid Surgery: a Randomized Clinical Trial at Mulago Hospital

Conditions
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Hospital Admission Duration, Postoperative Hematoma Formation, Wound Sepsis

Intervention / Treatment
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* Procedure: drain was inserted after thyroid surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients aged between 18 to 79 years with a diagnosis of goiter who consented to participate in the study Exclusion Criteria: We excluded patients with goiter who had a history suggestive of bleeding tendencies, recurrent goiter, and thyroid cancer with fixation of the thyroid gland to surrounding structures and had uncontrolled co-morbidities such as diabetes mellitus (DM) and hypertension (HT).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No drain<br>No drain was inserted after Thyroid surgery | |
| Experimental: Drain<br>A drain was inserted after thyroid surgery | Procedure: drain was inserted after thyroid surgery<br>* insertion of drain after thyroid surgery<br>* Other names: thyroid surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospital stay | Duration of hospital stay | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haematoma formation | post operative complication | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drain or no drain, Thyroid surgery, Randomized Trial