Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

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

+ No-drain after surgery

DeviceOther
Who is being recruted

Endocrine System Diseases+7

+ Pathologic Processes

+ Postoperative Complications

From 18 to 95 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Placebo-Controlled
Interventional
Study Start: November 2007
See protocol details

Summary

Principal SponsorKantonsspital Liestal
Last updated: February 25, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2007

Actual date on which the first participant was enrolled.

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.

NCT01679418
Principal SponsorKantonsspital Liestal
Last updated: February 25, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

139 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 95 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesPathologic ProcessesPostoperative ComplicationsSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsNauseaThyroid DiseasesVomitingPostoperative Nausea and Vomiting

Criteria

4 inclusion criteria required to participate
euthyreostatic preoperative condition
informed consent
older than 18 years of age
planed thyroid- or parathyroid resection
6 exclusion criteria prevent from participating
known postoperative nausea and vomiting prior to surgery
no informed consent
pregnancy
retrosternal struma
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Patients in group A received a wound drain after surgery.

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Kantonsspital Liestal

Liestal, SwitzerlandOpen Kantonsspital Liestal in Google Maps
CompletedOne Study Center