Thyroid Disease
Conditions
Keywords
thyroidectomy, postoperative pain, wound healing
Brief summary
Influence of the platysma suture on postoperative pain and wound healing.
Detailed description
Does a running platysma suture after primary thyroid resection alter direct postoperative pain, wound healing and long term cosmetic results. Primary outcome measure is if the lack of a platysma-Suture decreases the postoperative pain (detected by the visual pain score 0-10) and reduces the pain medication (detected by the cumulative NSAID and opioid treatment per patient). The second Question to be answered is if the cosmetic scar result (detected by the Patient and Observer Scar Assessment Score) 6 month after thyroidectomy is better in the intervention group (no Platysma-Suture) or not.
Interventions
PROCEDUREplatysma suture
PROCEDUREno platysma suture
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* primary thyroid surgery
Exclusion criteria
* previous neck surgery * application of wound drainages * preoperative diagnosed malignancy * surgical extension beyond thyroid resection (e.g. lymphadenectomy) * preexisting coagulopathy * preexisting chronic pain syndromes * preexisting dependency on pain reliefs * preexisting disorders in wound healing (e.g. diabetes mellitus) * intolerance to any study medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | Pain at morning of the first postoperative day | visual analogue pain scale (0-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| wound infection | within 14 days postoperative | wound infections needing antibiotics or reintervention |
| scar cosmesis | 6 months after surgery | scar cosmesis according to patient and observer scar assessment scale (POSAS) |
| Postoperative Pain | Pain 6h after surgery, at the morning of the second postoperative day, 14 days after surgery | visual analogue pain scale (0-10) |
| Cervical Seroma/Hematoma | 14 days after surgery | clinical apparent swelling verified by ultrasound |
| Disorders of the functional anatomy of the neck | At six months postoperative | New onset of clinically described swallowing problems and reduced depression of the corners of the mouth |
Countries
Germany
Outcome results
None listed