Randomized Investigation of Thyroid Operation as Day Surgery

• ClinicalTrials.gov Identifier: NCT02891252
• Recruitment Status: Unknown
• First Posted: September 7, 2016
• Last Update Posted: September 7, 2016
• Sponsor: Zealand University Hospital
• Information provided by (Responsible Party): Zealand University Hospital

Tracking Information

• First Submitted Date: September 1, 2016
• First Posted Date: September 7, 2016
• Last Update Posted Date: September 7, 2016
• Study Start Date: May 2016
• Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 1, 2016): 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 ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 1, 2016)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Randomized Investigation of Thyroid Operation as Day Surgery
• Official Title: Randomized Investigation of Thyroid Operation as Day Surgery
• Brief Summary: 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Hemithyroidectomy
• Outpatient
• Hemmorhage

• Intervention: Procedure: outpatient procedure

Study Arms

• Active Comparator: outpatient
  outpatient
  Intervention: Procedure: outpatient procedure
• No Intervention: inpatient
  inpatient

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 1, 2016): 86
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2018
• Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT02891252
• Other Study ID Numbers: SJ-495
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: v

• Responsible Party: Zealand University Hospital
• Study Sponsor: Zealand University Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Zealand University Hospital
• Verification Date: May 2016