Is the Use of Drain for Thyroid Surgery Realistic?

NCT ID: NCT01771523

Last Updated: 2013-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-01-31

Brief Summary

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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).

Detailed Description

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Patients will include in the study will randomly allocate to drain and non-drain group on the basis of computer generated random number table. Patients with substernal goitre or non differentiated cancer will exclude from the study.

According to the thyroidal disorder, total thyroidectomy or lobectomy plus isthmectomy will be performed. The operating time will be defined as the time from the first incision to the last suture's placement. 4/0 polypropylene sutures will be used subcutaneously for wound closure. In the drain group a closed suction drain with negative pressure (Hemovac®) was brought out through a separate wound.

Conditions

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Goiter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

thyroidectomy

Group Type ACTIVE_COMPARATOR

Thyroidectomy

Intervention Type PROCEDURE

total thyroidectomy or lobectomy

Group 2

thyroidectomy use of drain

Group Type ACTIVE_COMPARATOR

Thyroidectomy

Intervention Type PROCEDURE

total thyroidectomy or lobectomy

use of drain

Intervention Type DEVICE

drain will be used

Interventions

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Thyroidectomy

total thyroidectomy or lobectomy

Intervention Type PROCEDURE

use of drain

drain will be used

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients required thyroidectomy

Exclusion Criteria

* Patients with substernal goitre or non differentiated cancer
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maltepe University

OTHER

Sponsor Role lead

Responsible Party

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manuk norayk manukyan

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Uğur Deveci, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Maltepe University, School of Medicine , General Surgery Department

Manuk N. Manukyan, Ass.Prof.

Role: STUDY_DIRECTOR

Maltepe University, School of Medicine, General Surgery Department

Abut Kebudi, Prof.

Role: STUDY_CHAIR

Maltepe University, School of Medicine, General Surgery Department

Fatih Altintoprak, Ass.Prof.

Role: PRINCIPAL_INVESTIGATOR

Sakarya University, School of Medicine, General Surgery Department

Neşe Yener, Ass.Prof.

Role: PRINCIPAL_INVESTIGATOR

Maltepe University, School of Medicine, Pathology Department

Sertan Kapakli, Ass.Prof.

Role: PRINCIPAL_INVESTIGATOR

Maltepe University, School of Medicine, General Surgery Department

Rahmi Çubuk, Ass.Prof.

Role: PRINCIPAL_INVESTIGATOR

Maltepe University, School of Medicine, Radiology Department

Locations

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Maltepe University School of Medicine, General Surgery Department

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 23819100 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/15946379

Is the routine drainage after surgery for thyroid necessary? A prospective randomized clinical study \[ISRCTN63623153\].

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2276675/

Drainage after total thyroidectomy or lobectomy for benign thyroidal disorders.

Other Identifiers

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mütf2

Identifier Type: -

Identifier Source: org_study_id

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