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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniela Mueller, Kantonsspital Liestal
ClinicalTrials.gov Identifier:
NCT01679418
First received: June 12, 2012
Last updated: September 5, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention
Postoperative Nausea and Vomiting
Device: Placement of a wound drain post surgery (Redon; Medicoplast)
Other: No-drain after surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Randomized Controlled Trial on the Impact of Postoperative Drainage on Nausea and Vomiting After Thyroid- and Parathyroid Surgery

Resource links provided by NLM:


Further study details as provided by Kantonsspital Liestal:

Primary Outcome Measures:
  • Assessment of post-operative nausea using visual analogue scale (VAS) [ Time Frame: 24 hours post surgery ] [ Designated as safety issue: No ]
    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.

  • Assessment of postoperative vomiting using visual analogue scale (VAS) [ Time Frame: 24 hours post surgery ] [ Designated as safety issue: No ]
    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

  • Assessment of post-operative nausea using visual analogue scale (VAS) [ Time Frame: 48 hours post surgery ] [ Designated as safety issue: No ]
    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.

  • Assessment of postoperative vomiting using visual analogue scale (VAS) [ Time Frame: 48 hours post surgery ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Antiemetic therapy post surgery in patients with and without postoperative drainage [ Time Frame: after 48 hours ] [ Designated as safety issue: No ]

    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.



Enrollment: 139
Study Start Date: November 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679418

Locations
Switzerland
Kantonsspital Liestal
Liestal, Basel-Landschaft, Switzerland, 4410
Sponsors and Collaborators
Kantonsspital Liestal
Investigators
Study Director: Christoph A Maurer, MD Professor of Surgery, Head of the Department, Kantonsspital Liestal
  More Information

Publications:
Responsible Party: Daniela Mueller, Principal investigator, Kantonsspital Liestal
ClinicalTrials.gov Identifier: NCT01679418     History of Changes
Other Study ID Numbers: PONV_thyroidsurgery
Study First Received: June 12, 2012
Last Updated: September 5, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Kantonsspital Liestal:
PONV
thyroid
surgery
nausea and vomiting
postoperative

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014