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

Not Applicable

Completed

• Conditions: Hospital Admission Duration; Postoperative Hematoma Formation; Wound Sepsis
• Interventions: Procedure: drain was inserted after thyroid surgery

• Registration Number: NCT01729741
• Lead Sponsor: Makerere University

Brief Summary

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

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

Study Timeline

• Status Verified: 2010-12
• Study Start: 2010-12
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-11-19
• Last Update Submitted: 2012-11-19
• Study First Posted: 2012-11-20
• Last Update Posted: 2012-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• All adult patients aged between 18 to 79 years with a diagnosis of goiter who consented to participate in the study

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drain	drain was inserted after thyroid surgery	A drain was inserted after thyroid surgery

Primary Outcome Measures

Name	Time	Method
Duration of hospital stay	7 days	Duration of hospital stay

Secondary Outcome Measures

Name	Time	Method
Haematoma formation	7 days	post operative complication

Trial Locations

Locations (2)

Mulago Hospital; 🇺🇬 Kampala, Uganda

Makerere University; 🇺🇬 Kampala, Uganda