The Shrink Study

The Shrink Study - Shrinkage of mucosal margins following resection of Oral Squamous Cell Carcinoma with monopolar electric knife or thulium laser

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22691

Enrollment

Registered

2014-07-16

Start date

2014-04-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Oral Squamous Cell Carcinoma (OSCC) NL: Mondholtecarcinomen

Interventions

Resection using thulium laser or monopolar electric knife

Eligibility

Inclusion criteria

Inclusion criteria: - >18 years old - Confirmed OSCC stage I – IVa (Oncoline, 2004) - ASA classification I and II

Exclusion criteria

Exclusion criteria: - Previously operated/irradiated OSCC or other malignancy of the oral cavity. - Stage IVb (inoperable disease) - Co-morbidities resulting in disability to undergo surgery under general anesthesia - Inability to sign informed consent - impaired mental status

Design outcomes

Primary

Measure	Time frame
To compare mucosal shrinkage (from in vivo to histopathological examination) in each arm	—

Secondary

Measure	Time frame
- Shrinkage from in-vivo to directly after resection - Shrinkage from in-vivo to after formalin fixation - To define a shrink factor for each resection modality, taking into account the individual energy settings used.	—

Contacts

Public ContactA.J. Pothen

Otolaryngologist - Head and Neck surgeon Heidelberglaan 100

a.j.pothen@umcutrecht.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)