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

Primary Purpose

Hospital Admission Duration, Postoperative Hematoma Formation, Wound Sepsis

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
drain was inserted after thyroid surgery
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hospital Admission Duration focused on measuring Drain or no drain, Thyroid surgery, Randomized Trial

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Makerere University
  • Mulago Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No drain

Drain

Arm Description

No drain was inserted after Thyroid surgery

A drain was inserted after thyroid surgery

Outcomes

Primary Outcome Measures

Duration of hospital stay
Duration of hospital stay

Secondary Outcome Measures

Haematoma formation
post operative complication

Full Information

First Posted
November 14, 2012
Last Updated
November 19, 2012
Sponsor
Makerere University
Collaborators
Department of Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT01729741
Brief Title
Drain or no Drain After Thyroid Surgery: a Randomized Clinical Trial at Mulago Hospital
Official Title
Drain or no Drain After Thyroid Surgery: a Randomized Clinical Trial at Mulago Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Makerere University
Collaborators
Department of Surgery

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospital Admission Duration, Postoperative Hematoma Formation, Wound Sepsis
Keywords
Drain or no drain, Thyroid surgery, Randomized Trial

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No drain
Arm Type
No Intervention
Arm Description
No drain was inserted after Thyroid surgery
Arm Title
Drain
Arm Type
Experimental
Arm Description
A drain was inserted after thyroid surgery
Intervention Type
Procedure
Intervention Name(s)
drain was inserted after thyroid surgery
Other Intervention Name(s)
drains, thyroid surgery
Intervention Description
insertion of drain after thyroid surgery
Primary Outcome Measure Information:
Title
Duration of hospital stay
Description
Duration of hospital stay
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Haematoma formation
Description
post operative complication
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
wound sepsis
Description
post operative wound infection
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane O Fualal, MD
Organizational Affiliation
Mulago Hospital, Uganda
Official's Role
Study Chair
Facility Information:
Facility Name
Makerere University
City
Kampala
Country
Uganda
Facility Name
Mulago Hospital
City
Kampala
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
15946379
Citation
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.
Results Reference
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Drain or no Drain After Thyroid Surgery: a Randomized Clinical Trial at Mulago Hospital

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