Randomized Investigation of Thyroid Operation as Day Surgery
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|ClinicalTrials.gov Identifier: NCT02891252|
Recruitment Status : Unknown
Verified May 2016 by Zealand University Hospital.
Recruitment status was: Recruiting
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hemithyroidectomy Outpatient Hemmorhage||Procedure: outpatient procedure||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Investigation of Thyroid Operation as Day Surgery|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Active Comparator: outpatient
Procedure: outpatient procedure
No Intervention: inpatient
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891252
|Contact: Alexander Nygren, MDfirstname.lastname@example.org|
|Contact: Preben Homoe, Prof.||+email@example.com|
|Copenhagen University Hospital||Recruiting|
|Køge, Denmark, 4200|
|Contact: Alexander Nygren, MD +4522955265 firstname.lastname@example.org|