Impact of Drains on Postoperative Nausea and Vomiting After Thyroid Surgery

NCT ID: NCT01679418

Last Updated: 2016-02-25

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

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-06-30

Brief Summary

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Wound Drains after Thyroid- and Parathyroid Surgery Impact on Postoperative Nausea and Vomiting (PONV)

Detailed Description

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Postoperative nausea and vomiting (PONV) is common after thyroid surgery. Many patients describe PONV as more irritant in the postoperative course than the endured pain. Postoperative drains are put after thyroid surgery to early recognize bleeding and to collect wound secretion to avoid pressure on the trachea. Whether wound drains do impact on PONV is not known. Therefore, we tested the impact of wound drains on PONV after thyroid- and parathyroid surgery in a randomized controlled clinical trial.

Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Drain placement (Group A)

Patients in group A received a wound drain after surgery.

Group Type ACTIVE_COMPARATOR

Placement of a wound drain post surgery (Redon; Medicoplast)

Intervention Type DEVICE

The wound drain, type Redon Drainage 3.0 mm in diameter

No-drain placement (group B)

Patients assigned to group B, did not receive a wound drain after surgery.

Group Type SHAM_COMPARATOR

No-drain after surgery

Intervention Type OTHER

After surgery, no drain was put

Interventions

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Placement of a wound drain post surgery (Redon; Medicoplast)

The wound drain, type Redon Drainage 3.0 mm in diameter

Intervention Type DEVICE

No-drain after surgery

After surgery, no drain was put

Intervention Type OTHER

Other Intervention Names

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Redon Drainage (Ref. 750), 3.0 mm in diameter Medicoplast, 66557 Illingen, Germany

Eligibility Criteria

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Inclusion Criteria

* older than 18 years of age
* informed consent
* planed thyroid- or parathyroid resection
* euthyreostatic preoperative condition

Exclusion Criteria

* younger than 18 years of age
* pregnancy
* no informed consent
* retrosternal struma
* known postoperative nausea and vomiting prior to surgery
* severe and life threatening systemic health issues
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kantonsspital Liestal

OTHER

Sponsor Role lead

Responsible Party

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Christoph A. Maurer, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christoph A Maurer, MD

Role: STUDY_DIRECTOR

Professor of Surgery, Head of the Department, Kantonsspital Liestal

Locations

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Kantonsspital Liestal

Liestal, Basel-Landschaft, Switzerland

Site Status

Countries

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Switzerland

References

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Schwarz W, Willy C, Ndjee C. [Gravity or suction drainage in thyroid surgery? Control of efficacy with ultrasound determination of residual hematoma]. Langenbecks Arch Chir. 1996;381(6):337-42. doi: 10.1007/BF00191314. German.

Reference Type BACKGROUND
PMID: 9082107 (View on PubMed)

Kunzli BM, Walensi M, Wilimsky J, Bucher C, Buhrer T, Kull C, Zuse A, Maurer CA. Impact of drains on nausea and vomiting after thyroid and parathyroid surgery: a randomized controlled trial. Langenbecks Arch Surg. 2019 Sep;404(6):693-701. doi: 10.1007/s00423-019-01799-6. Epub 2019 Jun 26.

Reference Type DERIVED
PMID: 31243574 (View on PubMed)

Other Identifiers

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PONV_thyroidsurgery

Identifier Type: -

Identifier Source: org_study_id

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