Is the Routine Pressure Dressing After Thyroidectomy Necessary?

NCT00400465 | Completed Phase 4

• 2 other identifiers: HE49-1009ISRCTN52660978
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

Thyroidectomy is an operation that is commonly performed. After an operation a pressure dressing by Hypafix is usually used due to the belief that it will help to reduce complications such as post-operative bleeding or haematoma. However, the practice is uncomfortable to patients and makes it hard to detect early haematomas. We carried out a prospective randomised study to study the role of pressure dressing after thyroid surgery by evaluating the amount of fluids collected in the operative bed by ultrasonography compared with normal dressing.

Conditions

Thyroid Neoplasms; Thyroid Nodules; Graves Disease; Goiter

Keywords

thyroid; thyroidectomy; dressing

Outcome Measures

Primary Outcomes (1)

• amount of fluids collected in the operative bed by ultrasonography

  participants will be followed for the duration of hospital stay, an expected average of 4 days

Secondary Outcomes (3)

• Days retained drains

  participants will be followed for the duration of hospital stay, an expected average of 4 days

• days of hospital stay

  participants will be followed for the duration of hospital stay, an expected average of 4 days

• complication (bruise,bleeding,wound dehiscence)

  participants will be followed for the duration of hospital stay, an expected average of 4 days

Study Arms (2)

Control group

ACTIVE COMPARATOR

Pressure dressing

Procedure: Pressure dressing

Experimental group

EXPERIMENTAL

Normal dressing

Procedure: Normal dressing

Interventions

Normal dressing PROCEDURE

Normal dressing

Experimental group

Pressure dressing PROCEDURE

Pressure dressing

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients underwent thyroidectomy in Srinagarind hospital, Khonkaen University

You may not qualify if:

• Patients with cervical lymph nodes metastases requiring neck dissection
• Patients that tissue pathology shown anaplastic carcinoma
• Patients with clinical or laboratory indicators of coagulation disorders

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Deapartment of Otolaryngology, Srinagarind Hospital, Khonkaen University

Muang, Khonkaen, 40000, Thailand

Location

Related Publications (8)

• FALCAO P. [Use of compensated pressure dressing in thyroid surgery]. Rev Paul Med. 1951 Jul;39(1):64-6. No abstract available. Undetermined Language.

  PMID: 14865291 BACKGROUND

• FALCAO P. [Use of a compressive-compensed dressing in thyroid surgery]. Rev Bras Otorrinolaringol. 1951 May-Jun;19(3A):88-90. No abstract available. Undetermined Language.

  PMID: 14876034 BACKGROUND

• Abbas G, Dubner S, Heller KS. Re-operation for bleeding after thyroidectomy and parathyroidectomy. Head Neck. 2001 Jul;23(7):544-6. doi: 10.1002/hed.1076.

  PMID: 11400242 BACKGROUND

• Palestini N, Tulletti V, Cestino L, Durando R, Freddi M, Sisti G, Robecchi A. [Post-thyroidectomy cervical hematoma]. Minerva Chir. 2005 Feb;60(1):37-46. Italian.

  PMID: 15902052 BACKGROUND

• Cichon S, Anielski R, Orlicki P, Krzesiwo-Stempak K. [Post-thyroidectomy hemorrhage]. Przegl Lek. 2002;59(7):489-92. Polish.

  PMID: 12516234 BACKGROUND

• Agarwal A, Mishra SK. Post-thyroidectomy haemorrhage: an analysis of critical factors in successful management. J Indian Med Assoc. 1997 Jul;95(7):418-9, 433.

  PMID: 9425841 BACKGROUND

• Shaha AR, Jaffe BM. Practical management of post-thyroidectomy hematoma. J Surg Oncol. 1994 Dec;57(4):235-8. doi: 10.1002/jso.2930570406.

  PMID: 7990478 BACKGROUND

• Piromchai P, Vatanasapt P, Reechaipichitkul W, Phuttharak W, Thanaviratananich S. Is the routine pressure dressing after thyroidectomy necessary? A prospective randomized controlled study. BMC Ear Nose Throat Disord. 2008 Mar 20;8:1. doi: 10.1186/1472-6815-8-1.

  PMID: 18366712 DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Nodule; Graves Disease; Goiter; Thyroid Diseases

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Exophthalmos; Orbital Diseases; Eye Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Patorn Piromchai, MD

  Khonkaen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Otorhinolaryngology, Faculty of Medicine

Study Record Dates

• First Submitted: November 14, 2006
• First Posted: November 16, 2006
• Study Start: December 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: September 1, 2007
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

TH (1)