Randomized Investigation of Thyroid Operation as Day Surgery

Outpatient Clinical Trial

Official title:

Randomized Investigation of Thyroid Operation as Day Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02891252
• Other study ID #: SJ-495
• Status: Recruiting
• Phase: N/A
• First received: September 1, 2016
• Last updated: September 1, 2016
• Start date: May 2016
• Est. completion date: December 2018

Study information

• Verified date: May 2016
• Source: Roskilde County Hospital
• Contact: Alexander Nygren, MD
• Phone: +4522955265
• Email: alexander.nygren[@]gmail.com
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

hemithyroidectomy as a outpatient procedure is performed in some countries, it has never been done a RCT whether it is feasible

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Suspected malignancy Previous thyroid or major neck surgery Intrathoracic thyroid gland Former treatment with radioactive iodine Anticoagulation treatment except ASA and ADP inhibitors

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemithyroidectomy
• Hemmorhage
• Outpatient

Intervention

Procedure:
• outpatient procedure

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital	Køge

Sponsors (1)

Lead Sponsor	Collaborator
Roskilde County Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients that are converted to inpatient and/or re- admitted within 24h are under 20% in the outpatient group		24 h	Yes
Secondary	Patient acceptance to outpatient procedure from patient satisfactory questionnaire (Appendix 1).		4 weeks	No
Secondary	Difference in postoperative haemorrhage		24 h	No
Secondary	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.		24 h	No
Secondary	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.		24 h	No
Secondary	Difference in mean levels of NRS nausea at 2h, 20h (POD 0) and at 8h and 20h (POD1)		24 h	No
Secondary	Difference in NRS rated quality of sleep and level of tiredness at 8h on POD1		24 h	No