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

M

Makerere University

Status

Completed

Conditions

Wound Sepsis
Postoperative Hematoma Formation
Hospital Admission Duration

Treatments

Procedure: drain was inserted after thyroid surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT01729741
Rec Ref 2010-139

Details and patient eligibility

About

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

Full description

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

Enrollment

68 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

68 participants in 2 patient groups

No drain
No Intervention group
Description:
No drain was inserted after Thyroid surgery
Drain
Experimental group
Description:
A drain was inserted after thyroid surgery
Treatment:
Procedure: drain was inserted after thyroid surgery

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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