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

Wound Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01729741
• Other study ID #: Rec Ref 2010-139
• Status: Completed
• Phase: N/A
• First received: November 14, 2012
• Last updated: November 19, 2012
• Start date: December 2010
• Est. completion date: April 2011

Study information

• Verified date: December 2010
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hospital Admission Duration
• Postoperative Hematoma Formation
• Wound Sepsis

Intervention

Procedure:
• drain was inserted after thyroid surgery
insertion of drain after thyroid surgery

Locations

Country	Name	City	State
Uganda	Makerere University	Kampala
Uganda	Mulago Hospital	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
Makerere University	Department of Surgery

Country where clinical trial is conducted

Uganda, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	wound sepsis	post operative wound infection	7 days	Yes
Primary	Duration of hospital stay	Duration of hospital stay	7 days	Yes
Secondary	Haematoma formation	post operative complication	7 days	Yes