Impact of Drains on Postoperative Nausea and Vomiting After Thyroid Surgery

Postoperative Nausea and Vomiting Clinical Trial

— PONTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679418
• Other study ID #: PONV_thyroidsurgery
• Status: Completed
• Phase: N/A
• First received: June 12, 2012
• Last updated: February 24, 2016
• Start date: November 2007
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: Kantonsspital Liestal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Device:
• Placement of a wound drain post surgery (Redon; Medicoplast)
The wound drain, type Redon Drainage 3.0 mm in diameter

Other:
• No-drain after surgery
After surgery, no drain was put

Locations

Country	Name	City	State
Switzerland	Kantonsspital Liestal	Liestal	Basel-Landschaft

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Liestal

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. German. Erratum in: Langenbecks Arch Chir 1997;382(2):116. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of post-operative nausea using visual analogue scale (VAS)	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	No
Primary	Assessment of postoperative vomiting using visual analogue scale (VAS)	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	No
Primary	Assessment of post-operative nausea using visual analogue scale (VAS)	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	No
Primary	Assessment of postoperative vomiting using visual analogue scale (VAS)	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	No
Secondary	Antiemetic therapy post surgery in patients with and without postoperative drainage	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	No