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CompletedNCT01729741Updated Nov 20, 2012

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

An interventional study of drain was inserted after thyroid surgery in Hospital Admission Duration, Postoperative Hematoma Formation and Wound Sepsis, sponsored by Makerere University. Completed at 2 sites in Uganda. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2012-11-20.

Sponsored by Makerere University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Hospital Admission Duration
  • Postoperative Hematoma Formation
  • Wound Sepsis

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Keywords

  • Drain or no drain
  • Thyroid surgery
  • Randomized Trial
03

In context

Hematoma

247 studies on the registry are indexed under Hematoma; 54 are open to participants now.

This study's enrollment of 68 is below the median of 100 across 173 interventional studies indexed under Hematoma.

Browse Hematoma studies →

Lead sponsor

Makerere University is the lead sponsor of 143 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts 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

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).
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • No intervention
    No drain

    No drain was inserted after Thyroid surgery

  • Experimental
    Drain

    A drain was inserted after thyroid surgery

    Procedure: drain was inserted after thyroid surgery

Interventions

  • Proceduredrain was inserted after thyroid surgery

    insertion of drain after thyroid surgery

    Also known as: drains, thyroid surgery

06

What researchers measure

Primary outcomes

  1. Duration of hospital stay

    Duration of hospital stay

    Time frame: 7 days

Secondary outcomes

  1. Haematoma formation

    post operative complication

    Time frame: 7 days

Other outcomes

  1. wound sepsis

    post operative wound infection

    Time frame: 7 days

07

Study locations

2 sites
  • Makerere University
    Kampala, Uganda
  • Mulago Hospital
    Kampala, Uganda
08

References and documents

Publications

  • Khanna J, Mohil RS, Chintamani, Bhatnagar D, Mittal MK, Sahoo M, Mehrotra M. Is the routine drainage after surgery for thyroid necessary? A prospective randomized clinical study [ISRCTN63623153]. BMC Surg. 2005 May 19;5:11. doi: 10.1186/1471-2482-5-11. PubMed 15946379 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01729741
Lead sponsor
Makerere University
Collaborators
Department of Surgery
Responsible party
Sponsor
First posted
Nov 20, 2012
Start date
Dec 2010
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Nov 20, 2012

Study contacts

Jane O Fualal, MD
study chair · Mulago Hospital, Uganda

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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