Randomized Investigation of Thyroid Operation as Day Surgery

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

Study Overview

• Status: Unknown
• Conditions: Outpatient; Hemithyroidectomy; Hemmorhage
• Intervention / Treatment: Procedure: outpatient procedure

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 Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Nygren, MD; Phone Number: +4522955265; Email: alexander.nygren@gmail.com
• Study Contact Backup: Name: Preben Homoe, Prof.; Phone Number: +4547329609; Email: prho@regionsjaelland.dk

Study Locations

• Denmark
  • Køge, Denmark, 4200
    • Recruiting
    • Copenhagen University Hospital
    • Contact: Alexander Nygren, MD; Phone Number: +4522955265; Email: alexander.nygren@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: outpatient	Procedure: outpatient procedure
No Intervention: inpatient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients that are converted to inpatient and/or re- admitted within 24h are under 20% in the outpatient group	24 h

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient acceptance to outpatient procedure from patient satisfactory questionnaire (Appendix 1).	4 weeks
Difference in postoperative haemorrhage	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.	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.	24 h
Difference in mean levels of NRS nausea at 2h, 20h (POD 0) and at 8h and 20h (POD1)	24 h
Difference in NRS rated quality of sleep and level of tiredness at 8h on POD1	24 h

Collaborators and Investigators

• Sponsor: Zealand University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 1, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: SJ-495

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: v