Randomized Investigation of Thyroid Operation as Day Surgery
1 other identifier
interventional
86
1 country
1
Brief Summary
hemithyroidectomy as a outpatient procedure is performed in some countries, it has never been done a RCT whether it is feasible
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedSeptember 7, 2016
May 1, 2016
1.6 years
September 1, 2016
September 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients that are converted to inpatient and/or re- admitted within 24h are under 20% in the outpatient group
24 h
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
outpatient
ACTIVE COMPARATORoutpatient
inpatient
NO INTERVENTIONinpatient
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Suspected malignancy Previous thyroid or major neck surgery Intrathoracic thyroid gland Former treatment with radioactive iodine Anticoagulation treatment except ASA and ADP inhibitors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Copenhagen University Hospital
Køge, 4200, Denmark
Related Publications (1)
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.
PMID: 38235985DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2016
First Posted
September 7, 2016
Study Start
May 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
September 7, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will share
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