Study Comparing Fibula Free-flap MR With or Without PVP in Patients With OOPC

Oral health-related quality of life (QoL) measured 1 year after surgery using the GOHAI in the 2 groups of patients (MR with or without PVP).

The GOHAI is an oral-disease-specific QoL measure made by the patient. The GOHAI comprises 12 items grouped into three dimensions: the functional dimension (eating, speaking, swallowing); the pain or discomfort dimension (drugs, gingival sensitivity, discomfort when chewing certain foods); and, the psychosocial dimension (concerns, relational discomfort, appearance). The response format for each item is based on a five-point Likert scale: always = 1; often = 2; sometimes = 3; seldom = 4; never = 5. A summary score (ranging from 0 to 60) is calculated for each patient with a higher score indicating better oral health. GOHAI scores close to 30 have been reported in head and neck cancer patients after oncologic surgery and pedicled or free flap reconstruction.

Mean and median time between randomization and surgery

Mean and median total operative time and mean and median flap ischemia time

Surgical complication rates defined as local complication requiring another intervention in the first postoperative month, including free-flap failure rates

Delayed surgical complication rates defined as local complication occurring after the first postoperative month: non-union (pseudo-arthrosis), osteosynthesis-associated infection…

The PSS-HN is a 3-item scale designed to evaluate functional performance of H&N cancer patients, specifically Normalcy of Diet, Eating in Public, and Understandability of Speech. Each subscale is rated based on semi-structured interview with a score of 0 to 100, with higher scores indicating better performance. The subscale scores are reported separately, and the Normalcy of Diet subscale will be the primary score of interest for this trial.

The PSS-HN can be rated by health professionals including speech & language therapists and research nurses. The person collecting this data will remain consistent, as far as is feasible, throughout the course of the study. Scores are determined following an unstructured interview.

Functional outcomes assessed by mouth opening range/capacity at baseline and at 1 year.

It will be performed by using a caliper square to measure in millimeters the inter-incisor gap, assessed by the investigator.

The MDADI is a self-administered questionnaire designed specifically for evaluating the impact of dysphagia on the QoL of patients with head and neck cancer. It surveys QoL issues relevant to swallowing via several subscales: Emotional, Functional, and Physical. A fourth measurement, the Global subscale, is a single question designed to establish quickly an overall assessment that pertains to swallowing. A score ranging from 0 to 100 is calculated for each subscale, with higher scores indicating higher levels of dysphagia.

The SHI is a well-validated and widely used self-questionnaire for assessing speech problems in OOPC patients. It comprises 3 items and provides insight into the nature and severity of patients' complaints. Response categories for all but 1 item range on a 5-point scale (''never,'' ''almost never,'' ''sometimes,'' ''almost always,'' and ''always''). The questionnaire also includes an overall speech quality item, with 4 response categories (''good,'' ''reasonable,'' ''poor,'' and ''severe''). A total SHI score is calculated by summing all items (score range, 0-120), with higher scores indicating higher levels of speech related problems.

Functional dental status (>6; 4-6, <4 functional dental units; type of dental rehabilitation) of the patients

Subjective assessment of the aesthetic outcome in the head and neck area using a visual analog scale (VAS) by the patient and the surgeon (assessed separately).

The AESTHETIC VAS is a validated, subjective measure for esthetical perception. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "very poor looking"(0) and "very nice looking" (10).

Morphological results measured by the differences between the preoperative and postoperative measurements on 3D-CT-scan. The mandibular angle (in degrees) measured the amplitude of the angle existing between the ramus and body of the mandible.

Morphological results measured by the differences between the preoperative and postoperative measurements on 3D-CT-scan. The bi-gonial diameter (in millimeter), a measure of the contracture/reduction of the arch, is intended to measure the preservation of the native mandibular arch anatomy.

Morphological results measured by the differences between the preoperative and postoperative measurements on 3D-CT-scan. The lateral deviation (in millimeter) of gnathion in relation to the midsagittal plane will determined the degree of mandibular asymmetry.

"no pain" (0) and "worst pain" (10).

Evolution of patient QoL GOHAI score at 6 months (this score will be compared to the score measured at baseline and at 1 year).

The GOHAI is an oral-disease-specific QoL measure made by the patient. The GOHAI comprises 12 items grouped into three dimensions: the functional dimension (eating, speaking, swallowing); the pain or discomfort dimension (drugs, gingival sensitivity, discomfort when chewing certain foods); and, the psychosocial dimension (concerns, relational discomfort, appearance). The response format for each item is based on a five-point Likert scale: always = 1; often = 2; sometimes = 3; seldom = 4; never = 5. A summary score (ranging from 0 to 60) is calculated for each patient with a higher score indicating better oral health. GOHAI scores close to 30 have been reported in head and neck cancer patients after oncologic surgery and pedicled or free flap reconstruction.

Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.

The EORTC QLQ-C30 is a general self-report questionnaire designed to assess QoL in cancer patients. It consists of five functioning scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea, and vomiting), a global QoL scale, and six single questions assessing additional symptoms commonly reported by cancer patients.

As recommended by the EORTC, the scales and single-item variables of the QLQ-C30 will be linearly transformed into a score from 0 to 100. A high score for a functioning scale and for the global QOL scale represents a better level of functioning, whereas a high score for a symptom scale or a single item scale denotes a high level of symptoms or problems.

The EORTC QLQ-H&N35 is a tumor specific self-report questionnaire for head and neck cancer patients including seven symptoms scales (pain, swallowing, senses, speech, social eating, social contacts, and sexuality) and six single items (teeth problems, mouth opening, dry mouth, sticky saliva, coughing, and feeling ill).

As recommended by the EORTC, the scales and single-item variables of the H&N35 questionnaire will be linearly transformed into a score from 0 to 100. A high score for a functioning scale and for the global QOL scale represents a better level of functioning, whereas a high score for a symptom scale or a single item scale denotes a high level of symptoms or problems.