Postoperative Nausea and VomitingPONTSNCT01679418
Impact of Drains on Postoperative Nausea and Vomiting After Thyroid Surgery
A study testing Placement of a wound drain post surgery (Redon; Medicoplast) and No-drain after surgery in people with Postoperative Nausea and Vomiting, run by Kantonsspital Liestal at 1 site in Switzerland.
Trial summary
Wound Drains after Thyroid- and Parathyroid Surgery Impact on Postoperative Nausea and Vomiting (PONV) Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Placement of a wound drain post surgery (Redon; Medicoplast) and No-drain after surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2007to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 18 years of age
- informed consent
- planed thyroid- or parathyroid resection
- euthyreostatic preoperative condition
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial on the Impact of Postoperative Drainage on Nausea and Vomiting After Thyroid- and Parathyroid Surgery
Wound Drains after Thyroid- and Parathyroid Surgery Impact on Postoperative Nausea and Vomiting (PONV)
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Placement of a wound drain post surgery (Redon; Medicoplast), No-drain after surgery
- Keywords
- PONV, thyroid, surgery, nausea and vomiting, postoperative
- Medical subject headings
- Postoperative Nausea and Vomiting, Thyroid Diseases, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of a wound drain post surgery (Redon; Medicoplast)Device
Also called Redon Drainage (Ref. 750), 3.0 mm in diameter, Medicoplast, 66557 Illingen, Germany
The wound drain, type Redon Drainage 3.0 mm in diameter
No-drain after surgeryOther
After surgery, no drain was put
| Study group | Role | What they receive |
|---|---|---|
| Drain placement (Group A) | Active comparator | Patients in group A received a wound drain after surgery. Receives: 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. Receives: Other: No-drain after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 48 hours post surgery
Secondary outcomes (1)
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.
Measured: after 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startNov 2007
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Liestal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph A. Maurer, MD, Kantonsspital Liestal
- Investigators
- Christoph A Maurer, MD, Study director, Professor of Surgery, Head of the Department, Kantonsspital Liestal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679418
- Sponsor's protocol ID
- PONV_thyroidsurgery
- Acronym
- PONTS
- Status last verified
- Aug 2012
- First submitted
- 12 Jun 2012
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 9082107Kunzli 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.
PubMed 31243574
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Impact of Postoperative Drainage on Nausea and Vomiting After Thyroid- and Parathyroid Surgery
- ClinicalTrials.gov ID
- NCT01679418
- Acronym / sponsor ID
- PONTS / PONV_thyroidsurgery
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- PONV, thyroid, surgery, nausea and vomiting, postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Kantonsspital LiestalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 6 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drain placement (Group A) | Active comparator | Device: Placement of a wound drain post surgery (Redon; Medicoplast)Patients in group A received a wound drain after surgery. |
| No-drain placement (group B) | Sham comparator | Other: No-drain after surgeryPatients assigned to group B, did not receive a wound drain after surgery. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- older than 18 years of age
- informed consent
- planed thyroid- or parathyroid resection
- euthyreostatic preoperative condition
Key exclusion criteria (6 listed)
- younger than 18 years of age
- pregnancy
- no informed consent
- retrosternal struma
- known postoperative nausea and vomiting prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placement of a wound drain post surgery (Redon; Medicoplast)Also: Redon Drainage (Ref. 750), 3.0 mm in diameter, Medicoplast, 66557 Illingen, GermanyThe wound drain, type Redon Drainage 3.0 mm in diameter | Device | Drain placement (Group A) |
| No-drain after surgeryAfter surgery, no drain was put | Other | No-drain placement (group B) |
Primary outcome
Assessment of post-operative nausea using visual analogue scale (VAS)
Time frame: 24 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)
Time frame: 24 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
Assessment of post-operative nausea using visual analogue scale (VAS)
Time frame: 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)
Time frame: 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
1 secondary outcome
Antiemetic therapy post surgery in patients with and without postoperative drainage
Time frame: after 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- Background: PubMed 9082107Schwarz 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.
- Derived from this study: PubMed 31243574Kunzli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph A Maurer, MD study director
Professor of Surgery, Head of the Department, Kantonsspital Liestal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of a wound drain post surgery (Redon; Medicoplast) and No-drain after surgery in people with Postoperative Nausea and Vomiting, run by Kantonsspital Liestal at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of post-operative nausea using visual analogue scale (VAS) (time frame: 24 hours post surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01679418, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2016.