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"The Shrink Study: shrink factor of resected tumour mucosa in patients with oral squamous cell carcinoma"

"The Shrink Study: shrink factor of resected tumour mucosa in patients with oral squamous cell carcinoma" - The Shrink Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41703
Enrollment
76
Registered
2014-04-23
Start date
2014-05-02
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

oral cancer oral squamous cell carcinoma

Interventions

Resection of oral cavity carcinoma with either a monopolar knife (MO) or thulium laser (TL)

Sponsors

Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: > 18 years old Confirmed OSCC stage I - IVa ASA classification I, II and III

Exclusion criteria

Exclusion criteria: Previously operated/irradiated in the field of surgery Stage IVb Physical status that is a contraindication for surgery in general anesthesia Mental impairment ;note: In the rare case that the surgeon pre- or peroperatively finds that the randomized modality is not suitable for resection of a patients tumor, this patient will be withdrawn from the study and treated as the surgeon thinks suitable.

Design outcomes

Primary

MeasureTime frame
The amount/percentage of mucosa shrinking for the two abovementioned resection modalities (MO en TL), and hereby adjust margin interpretation method using the energy used for the electric resection modalities.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)