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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01729741
Enrollment
68
Registered
2012-11-20
Start date
2010-12-31
Completion date
2011-04-30
Last updated
2012-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospital Admission Duration, Postoperative Hematoma Formation, Wound Sepsis

Keywords

Drain or no drain, Thyroid surgery, Randomized Trial

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

Interventions

PROCEDUREdrain was inserted after thyroid surgery

insertion of drain after thyroid surgery

Sponsors

Department of Surgery
CollaboratorAMBIG
Makerere University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Duration of hospital stay7 daysDuration of hospital stay

Secondary

MeasureTime frameDescription
Haematoma formation7 dayspost operative complication

Other

MeasureTime frameDescription
wound sepsis7 dayspost operative wound infection

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026