The effect of dexamethasone on functional pain following Transoral Robotic Surgery: a randomized double blinded clinical trial.

BACKGROUND: Pain is prevalent after most TransOral Robotic Surgery (TORS) procedures and may limit function i.e. swallowing. Currently, there is limited knowledge regarding optimal pain treatment in TORS. AIMS/OBJECTIVES: This clinical trial randomized patients to either a high-dose dexamethasone or low-dose dexamethasone treatment in addition to a multimodal basic analgesic protocol. The aim of the trial was to investigate the pain intensity during rest and swallowing using the Visual Analogue Scale (VAS) after TORS lingual tonsillectomy. Secondary outcomes were acceptable food consistency, nausea, vomiting, opioid rescue usage, length of hospitalization, feeding tube placements, readmissions, blood glucose levels and postoperative complications. METHODS: The trial was conducted between August 2020 and October 2022. Eligible patients were patients scheduled for TORS-L treatment of obstructive sleep apnea syndrome or as part of the diagnostic work-up of head and neck carcinoma of unknown primary. RESULTS: Eighteen patients were and randomized 1:1. There were overall no significant differences between groups in the reported VAS scores during rest or swallowing (p ≥ .05). Overall, there were no differences in the secondary outcomes. CONCLUSION: There were no differences in the pain intensity in the two treatment groups allocated to a basic multimodal analgesic package and either high-dose dexamethasone or low-dose dexamethasone treatment. The trial is the first RCT to include pain measurement during a procedure-relevant activity, thus creating a platform for future recovery studies.

Why in hospital following transoral robotic lingual tonsillectomy?

BACKGROUND: The reported hospital length of stay (LOS) following transoral robotic surgery lingual tonsillectomy (TORS-L) is variable, with limited understanding of the factors requiring hospitalization and no evidence-based criteria for discharge. AIMS/OBJECTIVES: This observational cohort study investigated factors hindering discharge following TORS-L in a well-defined postoperative care program. METHODS: Patients were included between August 2020 and October 2022. A discharge scheme was filled out twice daily, specifying the factor(s) for hospitalization among patients undergoing TORS-L. This trial was a sub-investigation of a national multicentre randomized clinical trial (RCT) testing the efficiency of high-dose dexamethasone on postoperative pain control. Participation in the RCT demanded admission to the fourth postoperative day as dexamethasone/placebo was given intravenously in repeated dosages till day 4 postoperatively. RESULTS: Eighteen patients were included in the analysis. The main factor for hospitalization was nutritional difficulties, while pain was a limiting factor for discharge only on the first postoperative 1-3 days. More than half of the patients could have potentially been discharged on postoperative day 2 when omitting the RCT treatment plan in the analysis. CONCLUSION: The study estimates that the majority of patients may be discharged on postoperative day 2 following TORS-L.

Effectiveness and safety of mesenchymal stem/stromal cell for radiation-induced hyposalivation and xerostomia in previous head and neck cancer patients (MESRIX-III): a study protocol for a single-centre, double-blinded, randomised, placebo-controlled, phase II study.

BACKGROUND: A predominant side effect of radiotherapy for head and neck cancer is salivary gland hypofunction and xerostomia leading to debilitating oral disorders and impaired quality of life (QoL). Intraglandular mesenchymal stem cell therapy has shown promising results as a treatment for xerostomia. METHODS: This is a randomised, double-blinded, placebo-controlled, parallel-group, prospective, single-centre trial investigating the safety, tolerability, and effectiveness of allogeneic stem cells as a treatment for radiation-induced hyposalivation and xerostomia for previous head and neck cancer patients. We will include a total of 120 patients who previously have been treated with radiotherapy for a head and neck cancer in Denmark. Participants will be randomly assigned using block randomisation to one of two parallel groups in a 1:1 ratio to receive ultrasound-guided injection of allogeneic adipose-derived mesenchymal stem cell (ASC) (n = 60) or placebo (n = 60) into the submandibular glands. Placebo will consist of CryoStor10 (BiolifeSolutions), the freeze media for ASCs containing 10% dimethyl sulfoxide (DMSO). The primary endpoint is change in unstimulated whole saliva flow rate. The secondary endpoints are change in stimulated whole saliva flow rate, QoL, and composition of saliva. Further secondary endpoints are safety and immune response (human leukocyte antigen (HLA) response) to the stem cells will be assessed. Patients are evaluated at baseline (before treatment), after 4 months, and after 12 months. All study personnel, except study personnel thawing and preparing the treatment for injection, and participants will be blinded to group assignment. Unblinded study personnel will not participate in the outcome assessment. DISCUSSION: The trials will investigate the efficacy and safety of ASC injection to the submandibular gland as a potential new treatment for post-radiation xerostomia. We hope the results will pave the way for a clinically relevant treatment to ameliorate patients with xerostomia, a severely hampering condition. TRIAL REGISTRATION: The study is approved by the Danish Data Protection Agency (protocol number P-2020-1164), the National Ethics Committee protocol number: (Protocol number: 1802872), and the Danish Medical Agency (2018-000348-24). The protocol was registered at the ClinicalTrials.gov database (NCT04776538).

[Transoral robotic surgery for the head and neck].

Transoral robotic surgery (TORS) has been utilized in the head and neck field for more than a decade. It is a minimally invasive technique which ensures flexible instrumentation and 3D visualization of the oropharynx. This has led to a paradigm shift in the treatment of early-stage oropharyngeal cancer and in the diagnostic management of unknown primary of the head and neck. Over time, the indications for TORS have broadened. This review discusses the development, current indications, and future perspectives of TORS within head and neck surgery.

Days alive and out of hospital after treatment for oropharyngeal squamous cell carcinoma with primary transoral robotic surgery or radiotherapy - a prospective cohort study.

BACKGROUND: With the rising incidence of oropharyngeal squamous cell cancer, there is a need to assess the burden of treatment. AIMS/OBJECTIVES: This study assessed 'days alive and out of hospital' (DAOH) in a cohort of patients with oropharyngeal squamous cell carcinoma (OPSCC) treated with either transoral robotic surgery (TORS) or radiotherapy (RT). MATERIAL AND METHODS: A prospective cohort study conducted between May 2017-June 2019. Primary outcome was DAOH in the first 30 days after treatment (DAOH30). The secondary outcome was DAOH180. RESULTS: Forty-four patients were included, 31 treated with TORS and 13 with RT. Patients treated with TORS had a median DAOH30 of 25 (IQR 22.8-26) including a required four-day postoperative stay- and a median DAOH180 of 168 (IQR 163-171.3). In contrast, patients treated with RT had a median DAOH30 of 30 (IQR 26-30) and a DAOH180 of 143 days (IQR 135.5-149). CONCLUSIONS AND SIGNIFICANCE: DAOH has not been examined in oropharyngeal cancer before. We found, patients overall spent 92.5% of the first 180 days alive and out of hospital. Patients treated with TORS had high DAOH30, which remained high in DAOH180, while patients treated with RT with reduced DAOH30, had reduced DAOH180 calling for further large-scale studies.

Time course of subacute pain after transoral robotic surgery (TORS) for oropharyngeal squamous cell carcinoma versus traditional bilateral tonsillectomy in adults - a case-control study.

OBJECTIVE: To examine pain after Transoral Robotic Surgery (TORS) for oropharyngeal squamous cell carcinoma (OPSCC) versus traditional bilateral tonsillectomy in adults. METHODS: Pain evolvement was assessed in a prospective case-control design of 16 consecutive patients treated with TORS for early stage OPSCC versus 12 patients, who underwent bilateral tonsillectomy on suspicion of malignant disease. The TORS group received an optimized analgesia regime of preoperative oral celecoxib and gabapentin, intra- and postoperative high-dose intravenous dexamethasone, and regular postoperative oral contalgin, gabapentin, celecoxib, paracetamol and rescue morphine. The tonsillectomy group received the departmental standard analgesia regime with low-dose preoperative oral dexamethasone, celecoxib and paracetamol. Postoperative regular analgesia consisted of oral NSAID and paracetamol with weak opioids prescribed as required. Pain intensity was recorded at rest and during swallowing twice a day. RESULTS: The median pain intensity on postoperative day (POD) 1-4 was 2 in the TORS group versus 4.5 in the tonsillectomy group. From POD 5-10 median pain intensity was 3.5 and 4, respectively. The median length of stay was 5 days in the TORS group and less than 24 hours in the tonsillectomy group. CONCLUSION: With an optimized analgesia regime TORS for OPSCC can be performed with postoperative pain levels comparable to bilateral tonsillectomy in adults.