Investigate whether different resection modalities such as MO or TL cause a different amount of shrinkage in the mucosal margins of resected OSCCs.
ID
Source
Brief title
Condition
- Soft tissue neoplasms malignant and unspecified
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
not applicable
Background summary
Monopolar electro surgery (MO) and thulium laser (TL) are used for the
resection of oral squamous cell carcinomas (OSCC). These electric modalities,
MO and TL, have been evaluated at our Institution with regards to pathological
assessment and effectiveness (namely radical resections). Adequate pathological
assessment was possible when OSCCs were removed by MO or TL. Three times more
irradical resections were present in the MO group compared with the TL group.
Various factors were associated with the resection margins, such as
non-cohesive growth and tumor size. Since both resection modalities cause
thermal damage we question whether the MO causes more shrinkage of the resected
tissue than TL, subsequently resulting in smaller resection margins. We expect
that different resection modalities cause different shrinkage. Subsequently a
*shrink factor* could be calculated for each resection method, which could be
taken into account when interpreting resection margins and therefore could
result in a different postoperative therapy advice.
Hypothesis: Resection of OSCCs with MO causes more shrinkage of mucosal tissue
than resection performed with TL.
Study objective
Investigate whether different resection modalities such as MO or TL cause a
different amount of shrinkage in the mucosal margins of resected OSCCs.
Study design
Randomized controlled trial.
Intervention
Resection of oral cavity carcinoma with either a monopolar knife (MO) or
thulium laser (TL)
Study burden and risks
All included patients are eligible for surgical resection of the diagnosed OSCC
as primary treatment. All modalities used are standard methods of resection in
our institution. Within this study the resection modality used for each patient
will be randomized. The expected risk is as high as any otherwise performed
surgical resection of OSCCs. Intra- and postoperative bleeding, infections and
pain are standard risks. There is no direct benefit for any patient included in
this study. A possible consequence of the study results is a change of margin
interpretation after this study, possibly resulting in less aggressive
postoperative treatment (for example radiotherapy) and therefore improvement in
quality of life. These results will be evaluated in a bigger follow-up study
after analysis of this pilot study.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
> 18 years old
Confirmed OSCC stage I - IVa
ASA classification I, II and III
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45789.041.13 |