Impact of Drains on Postoperative Nausea and Vomiting After Thyroid Surgery (PONTS)
This study has been completed.
Sponsor:
Kantonsspital Liestal
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
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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:
|
|
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
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 June 18, 2013