RECONNECT Study

JRCT ID: jRCTs052210092

Registered date:28/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: head and neck cance
• Date of first enrollment: 20/12/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Surgery operation(neuroanastomosis)

Outcome(s)

Primary Outcome

The functional recovery score of the organ regulated by reconstructed nerve at postoperative after one year.
Each person's score is defined as an average score of reconstructions. If multiple reconstructions are performed.
Methods to measure the functional recovery score.
1.Vocal cord movement; endoscopy.
2.Facial movement; The facial movement of the relevant site of the face is evaluated by inspection.
3.Upper limb abduction movement; upper limb elevation angle.
4.Tongue movement; visual examination.

Functional recovery score
Not recovered (0)
Mild (1)
Moderate (2)
Complete (3)

Vocal cord movement
No movements are observed. (0)
Abduction or adduction is observed. (1)
Abduction and adduction are observed, but inferior to preoperative movement or to movement on healthy side. (2)
Abduction and adduction are observed, and equivalent to preoperative movement or to movement on healthy side. (3)

Facial movement
No movement of the relevant site of the face.(0)
Slight movement of the relevant site of the face.(1)
The movement of the relevant site of the face is clearly confirmed, but it does not lead to preoperative movement or healthy side movement.(2)
The movement of the relevant site of the face is equivalent to preoperative movement or healthy side movement.(3)

Upper limb abduction movement
<=90 degrees(0) 90 degrees <, <=120 degrees (1) 120<, <=150 degrees (2) 150 degrees < (3)

Tongue movement
Affected side deviation of the tip of the tongue. (0)
Affected side slight deviation of the tip of the tongue and not moved to the midline. (1)
Fixed near the midline. (2)
Movable to affected and healthy side. (3)

Secondary Outcome

1. Motor function recovery score for each part
It is evaluated by the methods (1-4) for each part.
2. Interval between surgery and functional recovery
It is calculated as a period from the date of surgery to the date of motor function recovery.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1.Resectable (no settings are set for surgical procedures) locally advanced head and neck cancer (histologically or cytological proven squamous cell carcinoma, papillary adenocarcinoma, follicular carcinoma, adenocarcinoma, adenoid cystic carcinoma, mucoepidermoid carcinoma) and scheduled to undergo reconstruction of single or multiple cranial nerves (hypoglossal nerve, vagus nerve or recurrent laryngeal nerve, accessory nerve, facial nerve).
2.Preoperatively diagnosed cT4, potential T4 which will be diagnosed during surgery, preoperatively diagnosed to be required cranial nerve reconstruction due to resectable cervical lymph node metastasis, likely to be required cranial nerve reconstruction due to resectable cervical lymph node metastasis during surgery.
3.Aged 18 to 80 years old.
4.ECOG Performance status 0 or 1.(within one month prior to obtaining consent)
5. Written informed consent

Exclude criteria

1.Nerve reconstruction on large defect lengths extending 4.0 cm or more.
2.Histologically or cytological proven undifferentiated carcinoma of thyroid.
3.Unresectable locally advanced head and neck cancer.
4. History of hypersensitivity for polyglycolic acid and collagen.
5. Judged by an investigator to be inappropriate for this study for any other reason.

Related Information

• Primary Sponsor: Uemura Hirokazu
• Secondary Sponsor: Toyobo Co., Ltd.