Impact of Drains on Postoperative Nausea and Vomiting After Thyroid Surgery (PONTS)

February 24, 2016 updated by: Christoph A. Maurer, MD, Kantonsspital Liestal

Randomized Controlled Trial on the Impact of Postoperative Drainage on Nausea and Vomiting After Thyroid- and Parathyroid Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Basel-Landschaft
      • Liestal, Basel-Landschaft, Switzerland, 4410
        • Kantonsspital Liestal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Drain placement (Group A)
Patients in group A received a wound drain after surgery.
Device: Placement of a wound drain post surgery (Redon; Medicoplast)
The wound drain, type Redon Drainage 3.0 mm in diameter
Other Names:
  • Redon Drainage (Ref. 750), 3.0 mm in diameter
  • Medicoplast, 66557 Illingen, Germany
Sham Comparator: No-drain placement (group B)
Patients assigned to group B, did not receive a wound drain after surgery.
Other: No-drain after surgery
After surgery, no drain was put

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of post-operative nausea using visual analogue scale (VAS)
Time Frame: 24 hours post surgery
The development of postoperative nausea was determined using a standard visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of nausea a number between 0 to 10.
24 hours post surgery
Assessment of postoperative vomiting using visual analogue scale (VAS)
Time Frame: 24 hours post surgery
The development of postoperative vomiting was determined using a standard Visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of vomiting indicating a number between 0 to 10. The number of vomiting was counted within the first 48h post surgery
24 hours post surgery
Assessment of post-operative nausea using visual analogue scale (VAS)
Time Frame: 48 hours post surgery
The development of postoperative nausea was determined using a standard visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of nausea a number between 0 to 10.
48 hours post surgery
Assessment of postoperative vomiting using visual analogue scale (VAS)
Time Frame: 48 hours post surgery
The development of postoperative vomiting was determined using a standard Visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of vomiting indicating a number between 0 to 10. The number of vomiting was counted within the first 48h post surgery
48 hours post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antiemetic therapy post surgery in patients with and without postoperative drainage
Time Frame: after 48 hours

In the postoperative course, we counted the amount of anti-emetic interventions for patients post surgery over the first 48 hours. The givage of anti-emetic drugs was based on a prior determined protocol, that was strictly followed.

The protocol was as follows for antiemetic drugs:

First line Drug: Tropisetron 2 mg i.v. when patient is vomiting, max. twice a day. Second line therapy: Haloperidol 0.5 mg i.v. with a maximum of 3 mg every 24 hours, when first line therapy is not sufficient. The change to second line therapy is controlled by the study physician.
after 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Liestal

Investigators

  • Study Director: Christoph A Maurer, MD, Professor of Surgery, Head of the Department, Kantonsspital Liestal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

September 5, 2012

First Posted (Estimate)

September 6, 2012

Study Record Updates

Last Update Posted (Estimate)

February 25, 2016

Last Update Submitted That Met QC Criteria

February 24, 2016

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PONV_thyroidsurgery

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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