Please select the eligibility criteria that correspond to the clinical trial below.
Title: Does the Harmonic Scalpel Reduce Operating Time and Blood Loss in Patients Undergoing Major Surgery for Oral Cavity Squamous Cell Carcinoma? A Prospective, Randomized Trial.
Brief Summary: The harmonic scalpel is a tool that may reduce operative blood loss. Some studies also indicate it may result in faster surgery. A recently published randomized study from our group shows the harmonic scalpel reduces blood loss in neck dissection but it did not offer any reduction in OR time. The present study investigates the utility of the harmonic scalpel in resections involving removal of oral cavity tissues as well as the neck. Oral cavity resections are especially prone to blood loss and we believe the harmonic scalpel will confer benefits in this type of surgery, potentially reducing the need for blood transfusion.


Options:
A: Inclusion Criteria:

* age \> 18 years
* oral cavity scc
* primary surgery including either uni or bilateral neck dissection (levels I-IV)

Exclusion Criteria:

* previous treatment for head and neck cancer
* unable or unwilling to give informed consent
* history of bleeding disorder
* other contraindications to surgery
B: Inclusion Criteria:

* Patients \>18yrs of age.
* histologically proven squamous cell carcinoma
* clinical and radiological N0 neck

Exclusion Criteria:

* Pregnant and lactating women

  * Patients with synchronous primaries
* H/o previous malignancy except BCC
* Previous surgeries on neck

  * Post radiotherapy recurrence.
C: Inclusion Criteria:

1. Histologically proven T1 or T2 N0 M0 (clinical) squamous cell carcinoma of the buccal mucosa, lower alveolus, oral tongue and floor of mouth.
2. Surgery is the preferred treatment and the primary tumor can be excised with clear margins via the per-oral route.
3. No history of a prior malignancy in the head and neck region.
4. No prior malignancy outside the head and neck region in the preceding 5 years.
5. Patient will be reliable for follow-up
6. Age\> 18 years and \< 75 years.
7. No significant co-morbid conditions - ASA grade II and I.
8. Understands the protocol and is able to give informed consent.

Exclusion Criteria:

1. Prior radiotherapy or surgery for malignancy in the head and neck region.
2. Non squamous cell carcinomas of the oral cavity.
3. Upper alveolus and palatal lesions where there is a possibility of retropharyngeal node involvement.
4. Per-oral excision of tumor will compromise margins in the opinion of the treating surgeon.
5. Significant co-existing pre-malignant conditions like erytho-leucoplakia and oral sub mucous fibrosis that in the opinion of the clinician would interfere in the planned treatment management of the patient.
D: DISEASE CHARACTERISTICS:

* Patients with oral squamous cell carcinoma measuring 1 to 3 cm at the primary site
* No clinical or preoperative imaging evidence of nodal involvement in the neck (N0)
* Surgery is the primary mode of treatment

  * Dose not need reconstruction that necessitates opening the neck, as assessed by the surgeon
* No cancer of the lip
* No prior head and neck tumor

PATIENT CHARACTERISTICS:

* No technical, medical, or anaesthetic difficulties that preclude patients being entered into one of the trial arms
* Not considered to be medically, socially, or psychiatrically unfit for surgery as first-line treatment by the multidisciplinary team
* No other synchronous tumor
* No preference for non-surgical treatment

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Answer: A