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

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

Study Overview

• Status: Completed
• Conditions: Wound Sepsis; Hospital Admission Duration; Postoperative Hematoma Formation
• Intervention / Treatment: Procedure: drain was inserted after thyroid surgery

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

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Makerere University
  • Kampala, Uganda
    • Mulago Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; insertion of drain after thyroid surgery; Other Names: drains; thyroid surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospital stay	Duration of hospital stay	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haematoma formation	post operative complication	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound sepsis	post operative wound infection	7 days

Collaborators and Investigators

• Sponsor: Makerere University
• Collaborators: Department of Surgery
• Investigators: Study Chair: Jane O Fualal, MD, Mulago Hospital, Uganda

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): April 1, 2011
• Study Completion (ACTUAL): April 1, 2011

Study Registration Dates

• First Submitted: November 14, 2012
• First Submitted That Met QC Criteria: November 19, 2012
• First Posted (ESTIMATE): November 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 20, 2012
• Last Update Submitted That Met QC Criteria: November 19, 2012
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Randomized Trial; Thyroid surgery; Drain or no drain
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Hematoma
• Other Study ID Numbers: Rec Ref 2010-139