Health Condition 1: C069- Malignant neoplasm of mouth, unspecified Health Condition 2: C07- Malignant neoplasm of parotid gland Health Condition 3: C73- Malignant neoplasm of thyroid gland Health Condition 4: C029- Malignant neoplasm of tongue, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Tata memorial hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Early oral cancers with clinic-radiologically node negative(cN0) neck(T1-3N0) planned for per-oral resection of primary and neck dissection through a standard horizontal neck crease incision as practised in our institute. 2. Interval neck dissections. 3. Benign and malignant tumours of parotid requiring adequate/superficial/total conservative parotidectomy +/- neck dissection. 4. Thyroid cancers planned for total thyroidectomy +/- neck dissection(central & lateral).
Exclusion criteria
Exclusion criteria: 1. Patient with prior history of neoadjuvant chemotherapy, radiotherapy, chemoradiotherapy. 2. Early oral cancers demanding elevation of cheek flap for resection of primary. 3. Advanced oral cancers(Stage III, IV) especially node positive cancers. •Neck dissections requiring a Schobinger;s incision. 4. Parotidectomies requiring extensive skin resection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1). To assess the adequacy of surgical exposure using self retaining retractor system in head and neck surgeries. 2). To evaluate safety of the self retaining retractor system in head and neck surgeries. 3). To study the requirement of manual retraction in head and neck surgeries. Timepoint: 1week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1). To assess various intra-operative parameters like set up time, number of surgical assistants utilised, documentation of steps mandating manual retraction, number of intra-operative readjustments, adequacy of surgical exposure in the mechanical retraction arm. 2). To compare duration of surgery, blood loss, skin flap changes and blunt injury to vascular/neurological/musculoskeletal structures among both arms. 3). To compare duration of hospital stay, drain outputs, postoperative pain scores, nerve paresis/palsy(facial/marginal mandibular/RLN), skin flap changes, lymph node yield, lymph node ratio, scar assessment among both arms. 4). To perform a cost-benefit analysis. Timepoint: 1month | — |
Countries
India
Contacts
Public ContactDr Prathamesh S Pai
Tata Memorial Hospital
Outcome results
None listed