Prospective Analysis of Epidemiological, Anatomical and Surgical Aspects Leading to a Limitation of the Opening of the Mouth Before and After Oral Cancer Surgery
试验速览
- 阶段
- 不适用
- 发起方
- KU Leuven
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- The correlation between the muscles of mastication and trismus.
研究概览
简要总结
A limited mouth opening (or trismus) after surgery for oral cancers is not only one of the most common complications, but it is also a major contributing factor towards an impaired quality of life after surgery. The enormous impact on the quality of life is secondary to impeded speech, feeding, drinking, and aesthetics.
The aim would be to analyse the opening of the mouth before and after surgery, and if applicable after radiotherapy, in a prospective way in oral cancer cases. There is namely a major discrepancy in current science research between the effect of different treatment modalities on trismus, as, in contrast with known research regarding the effect of surgery on trismus, a clear relation between radiotherapy and trismus has already been demonstrated in multiple research articles and systematic reviews. Nevertheless, the clinical experience of this research group supports the need for further investigation on the impact of surgery and the different modalities of surgery on trismus.
The investigators are convinced that revealing the surgical factors, linked with trismus, can lead to better prevention and prediction of later trismus for newly diagnosed oral cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with a newly diagnosed oral cancer.
- •Cases with a limited mouth opening secondary to oral tumour resections
排除标准
- •Deceased cases within the follow-up period of one year.
- •Other malignancies than oral squamous cell carcinomas.
结局指标
主要结局
The correlation between the muscles of mastication and trismus.
时间窗: Follow-up of twelve months.
Investigation of the relation between the muscles of mastication and the tumour and how this correlation influences the incidence of postsurgical trismus. Therefore, the distance between the tumor and the muscles of mastication will be evaluated in millimeters, based on 3D preoperative radiological imaging (CT or MRI).
Correlation of the mouth opening with surgical variables.
时间窗: Follow-up of twelve months.
The use of free vascularized grafts (primary closure/skin graft/composite grafts/soft tissue free flaps) and a neck dissection (yes/no) will be analyzed to identify an impact on the mouth opening of each surgical variable to prevent trismus in future cases. The information will be collected from the electronic patient file.
Correlation of the mouth opening with tumor recurrence.
时间窗: Follow-up of twelve months.
An evaluation of the influence of tumor recurrence (yes/no) on the maximal mouth opening will be ordered. The information will be collected from the electronic patient file.
A detailed quality of life assessment.
时间窗: Follow-up of twelve months.
This research group would like to obtain a detailed image of the impact of trismus and oral cancer resections in general on the quality of life. Results will be based on validated and commonly used questionnaires addressing the different aspects of quality of life for this specific population. More specific the Washington questionnaire.
Correlation of the mouth opening with tumor stage.
时间窗: Follow-up of twelve months.
The correlation between tumor stage(I-IV) (TNM-classification according to TNM-8 AJCC manual) and mouth opening will be analyzed. The information will be collected from the electronic patient file.
A detailed quality of life assessment regarding the mouth opening.
时间窗: Follow-up of twelve months.
This research group would like to obtain a detailed image of the impact of trismus and oral cancer resections in general on the quality of life. Results will be based on validated and commonly used questionnaires addressing the different aspects of quality of life for this specific population. More specific the Gothenburg questionnaire.
The evaluation of the maximal mouth opening.
时间窗: Follow-up of twelve months.
A first endpoint would be to compare the effect of the epidemiological and surgical variables on the maximal mouth opening in millimeters over time.
A detailed quality of life assessment regarding head and neck cancer treatment.
时间窗: Follow-up of twelve months.
This research group would like to obtain a detailed image of the impact of trismus and oral cancer resections in general on the quality of life. Results will be based on validated and commonly used questionnaires addressing the different aspects of quality of life for this specific population. More specific the EORTC H\&N 35.
An evaluation of the masseter muscle via ultrasound before and after oral tumor resections/trismus treatment.
时间窗: Follow-up of twelve months.
The final endpoint will be the evaluation of masseter alterations on ultrasound, which will lead to an improved understanding of muscular changes due to oncological resections, radiotherapy, and trismus. Even though newer (IMRT or intensity-modulated radiation therapy) techniques in radiotherapy protect vital structures as much as possible, the masseter is still often involved in the radiated area and muscular alterations are anyhow to be expected. The endpoints will be alterations in masseter muscle thickness (millimeter) in all oral oncology cases, trismus patients secondary to oral oncology resections, and in adjuvant radiotherapy cases.
次要结局
未报告次要终点