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

NCT ID: NCT01729741

Last Updated: 2012-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-04-30

Brief Summary

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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

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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

Conditions

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Hospital Admission Duration Postoperative Hematoma Formation Wound Sepsis

Keywords

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Drain or no drain Thyroid surgery Randomized Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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No drain

No drain was inserted after Thyroid surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Drain

A drain was inserted after thyroid surgery

Group Type EXPERIMENTAL

drain was inserted after thyroid surgery

Intervention Type PROCEDURE

insertion of drain after thyroid surgery

Interventions

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drain was inserted after thyroid surgery

insertion of drain after thyroid surgery

Intervention Type PROCEDURE

Other Intervention Names

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drains thyroid surgery

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Surgery

AMBIG

Sponsor Role collaborator

Makerere University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jane O Fualal, MD

Role: STUDY_CHAIR

Mulago Hospital, Uganda

Locations

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Makerere University

Kampala, , Uganda

Site Status

Mulago Hospital

Kampala, , Uganda

Site Status

Countries

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Uganda

References

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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.

Reference Type BACKGROUND
PMID: 15946379 (View on PubMed)

Other Identifiers

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Rec Ref 2010-139

Identifier Type: -

Identifier Source: org_study_id