Wound Sepsis Clinical Trial
Official title:
Drain or no Drain After Thyroid Surgery: a Randomized Clinical Trial at Mulago Hospital
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
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
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04062175 -
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Phase 4 |