Postoperative Pain, Why Still in Hospital and DAOH Following TORS for SCCUP

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This protocol investigates the effect of a high dose dexamethasone regimen in the treatment of postoperative pain following Transoral Robotic Surgery (TORS). The protocol consists of three substudies.

1. Randomized double-blinded clinical trial assigning half of the participants to a high-dose dexamethasone regimen while the other half will receive a low-dose dexamethasone dosage and placebo in the first postoperative period.

2. A investigation of "Why in hospital?" following TORS. From the first postoperative day until discharge reasons for continued hospitalization will be registered in order to identify clinical and organizational factors contributing to hospitalization

3. An assessment of "Days Alive and Out of Hospital" following TORS. From the day of surgery and the first 12 postoperative months all admissions to a hospital ward will be registered along with admission reasons. Any death during the first 12 months will be noted with a cause of death.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborators: Aarhus University Hospital; Candys Foundation; Odense University Hospital; Region Capital Denmark
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

• 18 years or older

• Ability to provide a written informed consent

• ECOG/WHO performance status 0-2

• Squamous cell carcinoma of unknown primary

• Booked for TORS based on radiologic and clinical assessment by an ENT surgeon

• Negative Urine HCG pregnancy test for women in the fertile age.

Exclusion Criteria:

• Serious medical comorbidities (ECOG/WHO performance status >2). Other contraindications to surgery

• Distant metastasis

• Active Herpes zoster

• Previous head and neck cancer

• Significant trismus, maximum inter-incisal opening 35mm

• Insulin dependent diabetes

• Allergy to glucocorticoids

• Preoperative daily use of systemic glucocorticoids <90 days before the surgery Glucocorticoids administered to the patient's routine examination under general anesthesia with bilateral biopsies from base of the tongue, adenoidectomy and concurrent tonsillectomy are not a part of this exclusion criteria. Only systemic daily use <90 prior TORS is an exclusion criterion.

• Preoperative use of biological anti-inflammatory medication <90 days before the surgery

• Active gastric ulcer in the opinion of the investigator

• Pregnancy/Breastfeeding