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NCT Number: NCT01679418

Impact of Drains on Postoperative Nausea and Vomiting After Thyroid Surgery

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

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Key information

Conditions

Postoperative Nausea and Vomiting Endocrine System Diseases Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Thyroid Diseases Vomiting

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Liestal

Liestal, Basel-Landschaft, 4410, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

No-drain after surgery

Other

After surgery, no drain was put

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kantonsspital Liestal

Other

Registry information

Official study title

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

Acronym: PONTS

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Sep 6, 2012
Registry last updated
Feb 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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