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

NCT01729741 | Completed DMC

• 1 other identifier: Rec Ref 2010-139
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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

Conditions

Hospital Admission Duration; Postoperative Hematoma Formation; Wound Sepsis

Keywords

Drain or no drain; Thyroid surgery; Randomized Trial

Outcome Measures

Primary Outcomes (1)

• Duration of hospital stay

  Duration of hospital stay

  7 days

Secondary Outcomes (1)

• Haematoma formation

  7 days

Other Outcomes (1)

• wound sepsis

  7 days

Study Arms (2)

No drain

NO INTERVENTION

No drain was inserted after Thyroid surgery

Drain

EXPERIMENTAL

A drain was inserted after thyroid surgery

Procedure: drain was inserted after thyroid surgery

Interventions

drain was inserted after thyroid surgery PROCEDURE

insertion of drain after thyroid surgery

Also known as: drains, thyroid surgery

Drain

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients aged between 18 to 79 years with a diagnosis of goiter who consented to participate in the study

You may not qualify if:

• 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).

Sponsors & Collaborators

• Makerere University: lead
• Department of Surgery: collaborator

Study Sites (2)

Makerere University

Kampala, Uganda

Location

Mulago Hospital

Kampala, Uganda

Location

Related 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. doi: 10.1186/1471-2482-5-11.

  PMID: 15946379 BACKGROUND

MeSH Terms

Interventions

Drainage

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Jane O Fualal, MD

  Mulago Hospital, Uganda

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 20, 2012
• Study Start: December 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 20, 2012

Record last verified: 2010-12

Locations

UG (2)