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NCT Number: NCT01729741

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

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Key information

Conditions

Hospital Admission Duration Postoperative Hematoma Formation Wound Sepsis

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Makerere University, Kampala, Uganda

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

drain was inserted after thyroid surgery

Procedure

insertion of drain after thyroid surgery

Other names: drains, thyroid surgery

Primary outcomes

  1. Duration of hospital stay

    Time frame: 7 days

    Duration of hospital stay

Secondary outcomes

  1. Haematoma formation

    Time frame: 7 days

    post operative complication

Other outcomes

  1. wound sepsis

    Time frame: 7 days

    post operative wound infection

Sponsors and collaborators

Lead sponsor

Makerere University

Other

Collaborators

  • Department of Surgery

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 20, 2012
Registry last updated
Nov 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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