Is the Use of Drain for Thyroid Surgery Realistic?

NCT01771523 | Completed DMC

• 1 other identifier: mütf2
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Background : The use of suction drains in thyroid surgery is common practice in order to avoid haematoma or seroma, as well as to identify promptly the onset of haemorrhaging that might compromise the patient's airway. The aim of this study to determine the effects of routine drainage compared to no drainage in thyroidectomy patients. Study Design : Total of 400 patients who undergoing total thyroidectomy or lobectomy for thyroidal disorders will be randomly allocated to be drained or not. Postoperative ultrasonographic (USG) neck examination will be performed for all patients on postoperative 24th hour by the same ultrasonologist each time. Postoperative pain, complications and hospital stay will be recorded. The statistical analysis will be performed and p\<0,05 will be accepted as an important statistical value (SPSS 16.0 for Windows).

Conditions

Goiter

Keywords

thyroidectomy; drain use

Outcome Measures

Primary Outcomes (1)

• Postoperative fluid accumulation (ml.)

  Standard thyroidectomy is proven method for safety. We will perform standard thyroidectomy in this study. In this period, patients will be monitored for bleeding and seroma. Major bleeding rare complication for thyroid surgery but requires re-operation immediately. Many studies suggested that drains may block with clotted blood and do not alert the surgeon, even if major bleeding occurs(1,2,3). We don't use drain routinely in standard thyroidectomy in our clinic for seven years. Bleeding and reoperation rates are similar between the literature and our clinic. The amount of fluid collection in thyroid bed will be assessed by Ultrasonography in postoperative 24th hours. Volume of fluid collection in the operative bed will be calculated by measuring the maximum diameter in three dimensions.Similar results between groups are evidence that the use of drain is not necessary.

  Postoperative first 24 hours

Secondary Outcomes (1)

• Postoperative pain score on the visual analog scale (0-10)

  6th hours and 24th hours

Other Outcomes (2)

• Number of postoperative complications.

  postoperative first 6th hour, 24th hour, third day, third month, sixth month, first year

• Length of hospital stay

  postoperative period (days)

Study Arms (2)

Group 1

ACTIVE COMPARATOR

thyroidectomy

Procedure: Thyroidectomy

Group 2

ACTIVE COMPARATOR

thyroidectomy use of drain

Procedure: Thyroidectomy; Device: use of drain

Interventions

Thyroidectomy PROCEDURE

total thyroidectomy or lobectomy

Group 1; Group 2

use of drain DEVICE

drain will be used

Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients required thyroidectomy

You may not qualify if:

• Patients with substernal goitre or non differentiated cancer

Sponsors & Collaborators

• Maltepe University: lead

Study Sites (1)

Maltepe University School of Medicine, General Surgery Department

Istanbul, 34843, Turkey (Türkiye)

Location

Related Publications (1)

• Deveci U, Altintoprak F, Sertan Kapakli M, Manukyan MN, Cubuk R, Yener N, Kebudi A. Is the use of a drain for thyroid surgery realistic? A prospective randomized interventional study. J Thyroid Res. 2013;2013:285768. doi: 10.1155/2013/285768. Epub 2013 May 30.

  PMID: 23819100 DERIVED

Related Links

• Thyroid surgery without drainage: 15 years of clinical experience.
• Is the routine drainage after surgery for thyroid necessary? A prospective randomized clinical study \[ISRCTN63623153\].
• Drainage after total thyroidectomy or lobectomy for benign thyroidal disorders.

MeSH Terms

Conditions

Goiter

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Uğur Deveci, Ass. Prof.

  Maltepe University, School of Medicine , General Surgery Department

  PRINCIPAL INVESTIGATOR

• Manuk N. Manukyan, Ass.Prof.

  Maltepe University, School of Medicine, General Surgery Department

  STUDY DIRECTOR

• Abut Kebudi, Prof.

  Maltepe University, School of Medicine, General Surgery Department

  STUDY CHAIR

• Fatih Altintoprak, Ass.Prof.

  Sakarya University, School of Medicine, General Surgery Department

  PRINCIPAL INVESTIGATOR

• Neşe Yener, Ass.Prof.

  Maltepe University, School of Medicine, Pathology Department

  PRINCIPAL INVESTIGATOR

• Sertan Kapakli, Ass.Prof.

  Maltepe University, School of Medicine, General Surgery Department

  PRINCIPAL INVESTIGATOR

• Rahmi Çubuk, Ass.Prof.

  Maltepe University, School of Medicine, Radiology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: January 18, 2013
• Study Start: January 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 18, 2013

Record last verified: 2013-01

Locations

TU (1)