HemithyroidectomyNCT02891252
Randomized Investigation of Thyroid Operation as Day Surgery
A study testing outpatient procedure in people with Hemithyroidectomy and Outpatient, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
hemithyroidectomy as a outpatient procedure is performed in some countries, it has never been done a RCT whether it is feasible Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemithyroidectomy, Outpatient, Hemmorhage
- What is being tested?
- outpatient procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteDenmark
- Study dates
- May 2016to Dec 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The hospitals normal outpatient criteria (ASA II or I), adult person to stay
- with patient on night of surgery) Euthyroid Normal function of vocal cords preoperatively Lives within a 30 km radius or within 45 minutes away with ambulance, from the hospital Speaks Danish
Who cannot join
- Suspected malignancy Previous thyroid or major neck surgery Intrathoracic thyroid gland Former treatment with radioactive iodine Anticoagulation treatment except ASA and ADP inhibitors
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital
Køge, 4200
Alexander Nygren, MD, +4522955265, alexander.nygren@gmail.com
About this study
hemithyroidectomy as a outpatient procedure is performed in some countries, it has never been done a RCT whether it is feasible
Read the detailed description
Many surgical procedures, which previously resulted in days to week's hospital admissions, are now done as outpatient procedures. This is the result of better surgical and anaesthesiology techniques as well as the economic incentive.
Examples from another surgical fields are cholecystectomy and further back in oto-rhino- laryngology (ORL) also tonsillectomy.
Hemithyriodectomy as an outpatient procedure is becoming increasingly popular and is already applied in some countries. However many European countries is continuing the procedure with hospital admission post-operatively (inpatient surgery), due to risk of complications. In Denmark hemithyroidectomy is currently done with at least one night hospital admission for observation of above mentioned . At the ORL department at Køge hospital it is annually performed approximately 200 hemithyroidectomies. It is a common procedure and the number of procedures yearly is increasing. Complications to hemithyroidectomy include postoperative haemorrhage, damage to the recurrent laryngeal nerve, hypothyroidism and infection and veryn rarely hypocalcaemia. With sufficient patient information, the above-mentioned complications can be managed in an outpatient setting. Postoperative haemorrhage is the most serious complication and thyroid surgery is unique in outpatient setting, considering the risk of cervical haemorrhage which secondary can lead to respiratory failure due to tracheal compression and laryngeal oedema in a rapid sequence. Incidence of haemorrhage after thyroid surgery varies from 0.19 % to 2.8 % of which most bleedings occur within six hours postoperatively. There are two different approaches in the event of post- operative haemorrhage; acute decompression bedside and acute re-operation.
Acute decompression is reserved for respiratory failures. Eligibility criteria for who may undergo outpatient thyroid surgery have been debated in the literature. No consensus has been reached for these criteria. For now, there is consensus that some patients (high risk of bleeding) will require inpatient procedure, and in carefully selected groups of patients outpatient thyroid surgery is already performed, as the inclusion criteria below. Outpatient hemithyroidectomy has shown low number of complications in retrospective studies as well as high patient acceptance and economical advantage in recent prospective and retrospective studies studies. However, recent national and international studies recommend against outpatient procedure, mainly due to the risk of late cervical haemorrhage. It is therefore important to continue to investigate whether hemithyroidectomyis feasible as an outpatient procedure, especially considering patient safety and acceptance. This will be done in a randomized controlled trial where half of the patients are allocated to outpatient procedure and the other half to inpatient procedure. The aim is non-inferiority comparing the two above-mentioned procedures. As far as the authors know, no previous RCT has been done or published with this purpose.
- Conditions
- Hemithyroidectomy, Outpatient, Hemmorhage
- Being tested
- outpatient procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
outpatient procedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| outpatient | Active comparator | outpatient Receives: Procedure: outpatient procedure |
| inpatient | No intervention | inpatient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients that are converted to inpatient and/or re- admitted within 24h are under 20% in the outpatient group
Measured: 24 h
Secondary outcomes (6)
Patient acceptance to outpatient procedure from patient satisfactory questionnaire (Appendix 1).
Measured: 4 weeks
Difference in postoperative haemorrhage
Measured: 24 h
Difference in mean level of NRS pain scores at rest based on measurements at 2h and 20h on POD0 and at 8h and 20 h on POD 1.
Measured: 24 h
Difference in mean level of NRS pain scores during swallowing of saliva based on measurements at 2h and 20h on POD0 and at 8h and 20 h on POD 1.
Measured: 24 h
Difference in mean levels of NRS nausea at 2h, 20h (POD 0) and at 8h and 20h (POD1)
Measured: 24 h
Difference in NRS rated quality of sleep and level of tiredness at 8h on POD1
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemithyroidectomyStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891252
- Sponsor's protocol ID
- SJ-495
- Status last verified
- May 2016
- First submitted
- 1 Sep 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: v
Publications
Haugaard CF, Homoe P, Nygren A, Mathiesen O, Hansen LN, Hvilsom GB. Randomised controlled trial of in- versus out-patient management of benign hemithyroidectomy. Dan Med J. 2023 Dec 6;71(1):A06230377.
PubMed 38235985
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Investigation of Thyroid Operation as Day Surgery
- ClinicalTrials.gov ID
- NCT02891252
- Acronym / sponsor ID
- SJ-495
- Conditions
- Hemithyroidectomy, Outpatient, Hemmorhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 7 Sep 2016 (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.
hemithyroidectomy as a outpatient procedure is performed in some countries, it has never been done a RCT whether it is feasible
Detailed description
Many surgical procedures, which previously resulted in days to week's hospital admissions, are now done as outpatient procedures. This is the result of better surgical and anaesthesiology techniques as well as the economic incentive.
Examples from another surgical fields are cholecystectomy and further back in oto-rhino- laryngology (ORL) also tonsillectomy.
Hemithyriodectomy as an outpatient procedure is becoming increasingly popular and is already applied in some countries. However many European countries is continuing the procedure with hospital admission post-operatively (inpatient surgery), due to risk of complications. In Denmark hemithyroidectomy is currently done with at least one night hospital admission for observation of above mentioned . At the ORL department at Køge hospital it is annually performed approximately 200 hemithyroidectomies. It is a common procedure and the number of procedures yearly is increasing. Complications to hemithyroidectomy include postoperative haemorrhage, damage to the recurrent laryngeal nerve, hypothyroidism and infection and veryn rarely hypocalcaemia. With sufficient patient information, the above-mentioned complications can be managed in an outpatient setting. Postoperative haemorrhage is the most serious complication and thyroid surgery is unique in outpatient setting, considering the risk of cervical haemorrhage which secondary can lead to respiratory failure due to tracheal compression and laryngeal oedema in a rapid sequence. Incidence of haemorrhage after thyroid surgery varies from 0.19 % to 2.8 % of which most bleedings occur within six hours postoperatively. There are two different approaches in the event of post- operative haemorrhage; acute decompression bedside and acute re-operation.
Acute decompression is reserved for respiratory failures. Eligibility criteria for who may undergo outpatient thyroid surgery have been debated in the literature. No consensus has been reached for these criteria. For now, there is consensus that some patients (high risk of bleeding) will require inpatient procedure, and in carefully selected groups of patients outpatient thyroid surgery is already performed, as the inclusion criteria below. Outpatient hemithyroidectomy has shown low number of complications in retrospective studies as well as high patient acceptance and economical advantage in recent prospective and retrospective studies studies. However, recent national and international studies recommend against outpatient procedure, mainly due to the risk of late cervical haemorrhage. It is therefore important to continue to investigate whether hemithyroidectomyis feasible as an outpatient procedure, especially considering patient safety and acceptance. This will be done in a randomized controlled trial where half of the patients are allocated to outpatient procedure and the other half to inpatient procedure. The aim is non-inferiority comparing the two above-mentioned procedures. As far as the authors know, no previous RCT has been done or published with this purpose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| outpatient | Active comparator | Procedure: outpatient procedureoutpatient |
| inpatient | No intervention | –inpatient |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The hospitals normal outpatient criteria (ASA II or I), adult person to stay
- with patient on night of surgery) Euthyroid Normal function of vocal cords preoperatively Lives within a 30 km radius or within 45 minutes away with ambulance, from the hospital Speaks Danish
Key exclusion criteria (1 listed)
- Suspected malignancy Previous thyroid or major neck surgery Intrathoracic thyroid gland Former treatment with radioactive iodine Anticoagulation treatment except ASA and ADP inhibitors
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 |
|---|---|---|
| outpatient procedure | Procedure or surgery | outpatient |
Primary outcome
Percentage of patients that are converted to inpatient and/or re- admitted within 24h are under 20% in the outpatient group
Time frame: 24 h
6 secondary outcomes
Patient acceptance to outpatient procedure from patient satisfactory questionnaire (Appendix 1).
Time frame: 4 weeks
Difference in postoperative haemorrhage
Time frame: 24 h
Difference in mean level of NRS pain scores at rest based on measurements at 2h and 20h on POD0 and at 8h and 20 h on POD 1.
Time frame: 24 h
Difference in mean level of NRS pain scores during swallowing of saliva based on measurements at 2h and 20h on POD0 and at 8h and 20 h on POD 1.
Time frame: 24 h
Difference in mean levels of NRS nausea at 2h, 20h (POD 0) and at 8h and 20h (POD1)
Time frame: 24 h
Difference in NRS rated quality of sleep and level of tiredness at 8h on POD1
Time frame: 24 h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Derived from this study: PubMed 38235985Haugaard CF, Homoe P, Nygren A, Mathiesen O, Hansen LN, Hvilsom GB. Randomised controlled trial of in- versus out-patient management of benign hemithyroidectomy. Dan Med J. 2023 Dec 6;71(1):A06230377.
- Individual participant dataSharing planned: Yes. v
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing outpatient procedure in people with Hemithyroidectomy and Outpatient, run by Zealand University Hospital at 1 site in Denmark.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Sep 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 Denmark. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Nygren, MD (+4522955265, alexander.nygren@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients that are converted to inpatient and/or re- admitted within 24h are under 20% in the outpatient group (time frame: 24 h). 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 NCT02891252, which also lists 1 linked publication.
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 7 Sep 2016.