Impact of Drains on Postoperative Nausea and Vomiting After Thyroid Surgery

Not Applicable

Completed

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

• Registration Number: NCT01679418
• Lead Sponsor: Kantonsspital Liestal

Brief Summary

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

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 Timeline

• Study Start: 2007-11
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2012-06-12
• Status Verified: 2012-08
• Study First Submitted QC: 2012-09-05
• Study First Posted: 2012-09-06
• Last Update Submitted: 2016-02-24
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No-drain placement (group B)	No-drain after surgery	Patients assigned to group B, did not receive a wound drain after surgery.
Drain placement (Group A)	Placement of a wound drain post surgery (Redon; Medicoplast)	Patients in group A received a wound drain after surgery.

Primary Outcome Measures

Name	Time	Method
Assessment of post-operative nausea using visual analogue scale (VAS)	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.
Assessment of postoperative vomiting using visual analogue scale (VAS)	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 Outcome Measures

Name	Time	Method
Antiemetic therapy post surgery in patients with and without postoperative drainage	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.

Trial Locations

Locations (1)

Kantonsspital Liestal; 🇨🇭 Liestal, Basel-Landschaft, Switzerland