Impact of Drains on Postoperative Nausea and Vomiting After Thyroid Surgery

NCT01679418 | Completed DMC

• 1 other identifier: PONV_thyroidsurgery
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Nausea and Vomiting

Keywords

PONV; thyroid; surgery; nausea and vomiting; postoperative

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (1)

• Antiemetic therapy post surgery in patients with and without postoperative drainage

  after 48 hours

Study Arms (2)

Drain placement (Group A)

ACTIVE COMPARATOR

Patients in group A received a wound drain after surgery.

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

No-drain placement (group B)

SHAM COMPARATOR

Patients assigned to group B, did not receive a wound drain after surgery.

Other: No-drain after surgery

Interventions

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

The wound drain, type Redon Drainage 3.0 mm in diameter

Also known as: Redon Drainage (Ref. 750), 3.0 mm in diameter, Medicoplast, 66557 Illingen, Germany

Drain placement (Group A)

No-drain after surgery OTHER

After surgery, no drain was put

No-drain placement (group B)

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 18 years of age
• informed consent
• planed thyroid- or parathyroid resection
• euthyreostatic preoperative condition

You may not qualify if:

• 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

Sponsors & Collaborators

• Kantonsspital Liestal: lead

Study Sites (1)

Kantonsspital Liestal

Liestal, Basel-Landschaft, 4410, Switzerland

Location

Related Publications (2)

• 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. doi: 10.1007/BF00191314. German.

  PMID: 9082107 BACKGROUND

• Kunzli BM, Walensi M, Wilimsky J, Bucher C, Buhrer T, Kull C, Zuse A, Maurer CA. Impact of drains on nausea and vomiting after thyroid and parathyroid surgery: a randomized controlled trial. Langenbecks Arch Surg. 2019 Sep;404(6):693-701. doi: 10.1007/s00423-019-01799-6. Epub 2019 Jun 26.

  PMID: 31243574 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Thyroid Diseases; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Endocrine System Diseases

Study Officials

• Christoph A Maurer, MD

  Professor of Surgery, Head of the Department, Kantonsspital Liestal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: September 6, 2012
• Study Start: November 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 25, 2016

Record last verified: 2012-08

Locations

CH (1)