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临床试验/CTRI/2024/02/062642
CTRI/2024/02/062642尚未招募不适用

Evaluation of the Deviation pattern following Mandibulectomy for Oral Cancer Patients - A Prospective Study

Homi Bhabha Cancer Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月26日

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To measure the deviation pattern following mandibulectomy for oral cancer patients reconstructed with soft tissue flap

研究概览

简要总结

Post-mandibulectomy rehabilitation involves a multidisciplinary approach which includes surgical reconstruction with bone/ reconstruction plate, the use of guide bite prosthesis and dental rehabilitation, and physical therapy depending on the clinical situation and patients’ individual needs.

Research gap:  Since patients with segmental mandibulectomy defect and soft tissue reconstruction represent a major cohort of mandibulectomy patients and no literature is present describing the amount of mandibular deviation in these patients, its correlation with the extent of the size of the surgical defect, type of soft tissue reconstruction, period elapsed from the surgery, and adjuvant treatment, use of guidance prosthesis. No guidance literature is present regarding how much time the guidance prosthesis should be used in these mandibulectomy patients. Prospective clinical studies can provide valuable insights into this complication’s prevalence, severity, and potential predictors.

The study aims to evaluate the Deviation pattern following Mandibulectomy for Oral Cancer Patients.

The primary objective is to measure the deviation pattern following mandibulectomy for oral cancer patients reconstructed with soft tissue flap.

All patients who are planning to undergo mandibulectomy for oral cancer will be eligible to participate in this study. Patient demographics including age, stage, treatment details of the surgery, reconstruction details, adjuvant radiotherapy, and/or chemotherapy will be retrieved from the case records and/or EMR. Hospital-based “Electronic Medical Record” will be reviewed to enter the clinical details.

Outcome evaluation would quantify the degree of deviation in millimeters and assess the prevalence and severity of mandibular deviation at various time intervals following surgery and will be compared with the baseline data before surgery. The deviations will be compared based on factors like the extent of the defect, radiation treatment, and prosthesis use. Chewing performance would be evaluated by the mixing ability. The chewing efficiency of study participants will be evaluated and compared between different subgroups based on the mentioned factors. The Quality of life would be evaluated by the EORTC QLQ-C30 and H&N35 questionnaires.  The outcome would assess the impact of mandibular deviation on the overall quality of life of participants and analyze differences in quality of life scores based on the time elapsed since surgery, the extent of the defect, radiation treatment, and prosthesis use. The outcome would also analyze the effect of guide bite prosthesis usage on mandibular deviation, chewing efficiency, and quality of life by comparing outcomes between users at different time points.

By measuring these outcomes and considering the mentioned factors, this study can provide valuable insights into how mandibular deviation impacts patients’ lives and how various factors influence this deviation, chewing efficiency, and overall quality of life following mandibulectomy.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Consecutive, adult oral cancer patients of all socioeconomic strata, 18-70 years age range who are planned to undergo resection of the mandible (± upper alveolus) for oral cancer and reconstruction with the soft tissue flap.
  • Have a total of 6 or more teeth in the planned non-resected side of jaw
  • Have a mouth opening of at least 1.5 cm before surgery.

排除标准

  • Patients with planned major composite surgeries like subtotal/total glossectomy or total maxillectomy limiting oral function.
  • Planned Jaw reconstruction with bone/reconstruction plate and
  • Planned marginal mandibulectomy cases.
  • Non-consenting patient
  • Recurrence cases.

结局指标

主要结局

To measure the deviation pattern following mandibulectomy for oral cancer patients reconstructed with soft tissue flap

时间窗: Baseline | 1 week after Surgery | Before radiation or1 month after surgery | After radiation or 3 months after surgery | 6 months after surgery | 9 months after surgery | 12 months after surgery

次要结局

  • To measure and correlate the pattern of mandibular deviation to the extent of defect in segmental mandibulectomy the type of soft tissue flaps used for reconstruction and the effect of adjuvant radiation treatment.(To evaluate and compare the deviation pattern in segmental mandibulectomy patients at different time points.)

研究者

发起方
Homi Bhabha Cancer Hospital and Research Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Pankaj Chauhan

Homi Bhabah Cancer Hospital and Research Centre

研究点 (1)

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