Abstract
Aim
We designed a prospective randomized study to assess the outcome of Colorado microdissection needle in comparison with conventional surgical blade for performing neck dissections.
Materials and Methods
Sixty patients who underwent neck dissection for oral cancers were randomly allocated into two groups. The outcome measurements were in terms of cosmetic outcome of neck scar, intraoperative blood loss, over all operative time, and postoperative neck drain assessment.
Results
The use of microdissection needle in performing skin incision and neck dissection eliminates the need for local anesthetic with vasoconstrictor along with significant reduction in intraoperative blood loss, postoperative drainage and with acceptable cosmetic outcome. No significant difference was seen in perioperative and postoperative complications between both groups.
Keywords: Colorado tip, Microdissection Needle, Neck dissection, OSCC, SND
Introduction
Neck dissection (ND) forms an integral part of treatment in oral squamous cell carcinomas (OSCC). Neck dissection is a procedure which involves removal of lymph nodes from specific areas of the neck and may include removal of important structures such as internal jugular vein, spinal accessory nerve and sternocleidomastoid muscle. ND involves working around vital structures, so there is an inherent possibility for intraoperative and postoperative complications. Most oral cancer patients also suffer from other systemic diseases which may preclude the use of certain drugs, namely local anesthetics with adrenaline, and may also have increased tendencies for intraoperative bleeding. Performing surgery in such patients demands high level of surgical skills with diligent use of available technology to prevent complications.
Several studies have demonstrated that the operative time and blood loss are related to the clinical outcomes and the complications [1].
Head and neck surgeons have traditionally been using scalpel dissections to perform ND along with the use of conventional electrosurgical unit which uses a large tip. Some of the disadvantages of using conventional scalpel blade for skin incision involve the use of large amount of vasoconstrictors to reduce bleeding from the skin incision.
The present prospective randomized trial study was designed to evaluate the efficacy and safety of Colorado microneedle in comparison with conventional surgical blade along with conventional large tip cautery in ND.
The primary objectives of this study were to assess the cosmetic outcome of the neck incision when microneedle is used for performing the entire procedure and also to calculate the intraoperative blood loss at the time of skin incision.
The secondary objectives were to compare between groups for overall operating time and postoperative drainage.
Materials and Methods
Between January 2012 and February 2019, 60 consecutive patients with untreated OSCC patients underwent ND with primary surgery performed by the same surgeon. The study was performed in accordance with Helsinki Declaration and was also approved by the local institutional review board. All patients were blinded to the surgical technique used and signed an informed consent before enrollment in the trial.
The inclusion criteria were:
Acceptance to participate in the study (signed informed consent form)
Patients requiring ND with primary OSCC.
The exclusion criteria were:
Coagulation disorders
Pregnancy
History of neck irradiation
Cases which required free or pedicled flap for reconstruction.
In all patients, ND was performed first followed by primary tumor resection.
Allocation of Subjects
The patients were randomly allocated to one of the groups by a third party who was not aware of the trial. All the surgeries were performed by a single designated operator for the sake of uniformity, whereas the relevant readings were recorded by the first operator who was blinded to the nature of the group. The blind was not broken until this clinical trial was completely finished.
Standardization of Surgical Procedure
We performed selective ND (SND) in patients with a clinically node negative neck. According to the primary site of the cancer, SND including level I to IV (SND I–IV) was performed for the treatment of oral cavity cancer.
Operative Procedure
Group I (Colorado Tip Group)
Standard lower cheek apron incision was used to perform the neck dissection in all cases. The incision in the Colorado group was performed using Colorado ® microdissection needle (Stryker-Leibinger, Freiburg im Breisgau, Germany) directly on the skin without the use of local anesthetic with adrenaline. After appropriate marking of the incision, Colorado needle tip was inserted up to the level of subcutaneous fat and the side of the needle dissector was drawn along the incision in a continuous stroke till the layer of platysmal muscle and further neck dissection was carried in the standard manner. The entire neck dissection in this group was performed using a Colorado microneedle tip utilizing monopolar current and bipolar forceps wherever deemed necessary (Fig. 1) (Fig. 2).
Fig. 2.
Cosmetic outcome following use of Colorado tip for skin incision
Fig. 1.
Colorado microdissection needle
Group II (Conventional Blade)
In group II, the incision was marked and a no. 15 surgical blade was used to perform the incision up to the subcutaneous fat. Once the platysma muscle was exposed, a large conventional cautery tip utilizing monopolar current along with bipolar forceps was used. The surgeon utilized no. 15 blade for nodal dissections along the IJV and in other areas where it was deemed necessary.
Outcomes of the study included operative time, intraoperative blood loss at the time of incision, fluid content in the suction drain (drainage volume) during the first 48 h after surgery, incidence of intraoperative complications such as major vessel and postoperative cosmetic assessment of the neck scar at 15 days, 1 month, and 6 month.
The neck scar was assessed using Stony Brook Scar Evaluation Scale as described by Singer et al. [2] in 2007 (Table 1). A good scar has higher points when calculated using this scale.
Table 1.
The Stony Brook Scar Evaluation Scale
| Scar category | Points | |
|---|---|---|
| Width | > 2 mm | 0 |
| ≤ 2 mm | 1 | |
| Height | Elevated/depressed in relation to surrounding skin | 0 |
| Flat | 1 | |
| Color | Darker than surrounding skin | 0 |
| Same color or lighter than surrounding skin | 1 | |
| Hatch marks/suture marks | Present | 0 |
| Absent | 1 | |
| Overall appearance | Poor | 0 |
| Good | 1 |
Inference
Total score can be from 0–5 points
Increasing points show tendency towards better cosmetic outcome of the final scar
The total operative time was noted down for all patients, and intraoperative blood loss at the time of skin incision was calculated using the visual assessment method of blood loss as described by Emran Ali Algadiem et al. [3]. The gauze used during the incision measured 10 × 10 cm and squeezed dry after it was dipped in saline. Fully soaked gauze would approximately hold 9 ml of blood.
The closure of the neck incision was performed by the same surgeon using 4-0 vicryl sutures for platysmal layer and staples for skin closure.
Closed suction drains were used to evaluate the overall amount of blood loss after the procedure and to assess the actual difference between the groups.
Results
The demographic characteristics of the patients such as age, sex, primary site of the tumor, nodal status, and type of SND are shown in Table 2. Both groups were homogeneous for age, sex, primary site of the tumor, TNM staging, and type of surgical treatment.
Table 2.
Demographic characteristics, sex ratio, stage of the tumor, and primary site in group I (Colorado microneedle) and group II (conventional dissection)
| Group I (n = 30) | Group II (n = 30) | Total (n = 60) | |
|---|---|---|---|
| Mean age (years) | 47 ± 13.90 | 47.53 ± 15.52 | |
| Sex (M/F) | 24/6 | 18/12 | 42/18 |
| Primary site | |||
| Buccal mucosa | 11 | 8 | 19 (31.6 %) |
| Tongue | 11 | 16 | 26 (43.3%) |
| RMT | 2 | 2 | 4 (6.6%) |
| Floor of mouth | 4 | 3 | 7 (11.6%) |
| Gingivo buccal sulcus | 2 | 1 | 3 (5%) |
| T stage | |||
| T1 | 20 | 13 | 23 (38.3%) |
| T2 | 8 | 11 | 19 (31%) |
| T3 | 2 | 6 | 8 (13.3%) |
| T4 | 0 | 0 | 0% |
| N stage | |||
| N0 | 23 | 25 | 48 (80%) |
| N1 | 7 | 5 | 12 (20%) |
| Neck dissection | |||
| SND (I–III) | 13 | 11 | 24 (40%) |
| SND (I–IV) | 17 | 19 | 36 (60%) |
Out of 30 patients in group I, 13 patients underwent selective neck dissection (SND) level I–III and 17 patients underwent SND I–IV as part of the treatment, whereas in group II (n = 30), 11 patients underwent SND I–III and 19 patients underwent SND I–IV. (Table 2).
For the patients in group I (Colorado microneedle group), the mean operative time was 70.33 ± 9.7 min when compared to the group II (conventional dissection) which was 90.83 ± 12.1 (P value 0.005) (Table 2).
The intraoperative blood loss at the time of skin incision was significantly less in group I compared to group II (4.7 ± 3.2 ml vs. 9.4 ± 3.0 ml; P value < 0.00001) (Table 3).
Table 3.
Intraoperative and postoperative data of group I (Colorado microneedle) and group II (conventional dissection)
| Group I | Group II | P value | t value | |
|---|---|---|---|---|
| Operative time (mean ± SD), min | 70.33 ± 9.7 | 90.83 ± 12.1 | < 0.00001 | − 7.20612 |
| Blood loss at the time of incision in ml | 4.7 ± 3.2 | 9.4 ± 3.0 | < 0.00001 | − 5.82963 |
| Total drainage fluid volume in ml | 168.86 ± 29.7 | 195.86 ± 42.3 | 0.005922 | − 2.85737 |
| Postoperative scar score | ||||
| 15 days | 0.06 ± 0.25 | 0.10 ± 0.30 | 0.619302 (not significant) | − 0.49957 |
| 1 month | 2.93 ± 1.01 | 2.4 ± 0.91 | 0.038305 | 2.11989 |
| 6 month | 3.96 ± 0.41 | 3.9 ± 0.60 | 0.621209 (not significant) | 0.4968 |
Total drainage fluid volume in ml was also found to be less in group I when compared to group II (168.86 ± 29.7 ml vs. 195.86 ± 42.3 ml; P value 0.005922) (Table 3).
The neck incision scars were evaluated utilizing the Stony Brook Scar Evaluation Scale which showed no significant difference in the appearance of scar at 15 days ( P value = 0.619302) and at the end of 6 months (P value = 0.621209) in both groups. However, there was some significance noted between group I and group II (P value = 0.038305) at the end of 1 month. (Table 3).
Fewer complications were noted in both groups, except for one case in group I where there was inadvertent puncture into the lumen of internal jugular vein as result of using microneedle.
Discussion
The use of electrosurgical unit in head and neck surgery has been proven to be advantageous in vast number of studies over the past years. The potential advantages of electrocautery include minimal blood loss and quicker surgical time. Electrocautery can potentially be a mechanism to minimize blood exposure while avoiding the use of the scalpel, particularly in patients who are at high risk of having a blood-borne, communicable disease [4, 5].
Heat generated by electrosurgical devices is influenced by factors such as duration of contact between tissue and electrode, current intensity, and the electrode tip size. A larger tip causes more tissue damage, increased operating power, and more amount of lateral heat production. This led to the development of microdissection needles which could effectively negate these problems. The Colorado needle is an ultra-sharp microdissection needle which is designed for precision cutting and coagulation. (Fig. 1).
The use of electrosurgical dissection has traditionally led to reduced operative time and intraoperative bleeding; through this study design, we wanted to evaluate the effect of using a microneedle for the entire procedure. The microneedle tip was used with a blend current ranging from 15–20 w and adjusted accordingly for every surgery reaching an optimum level where there is minimum tissue drag without sparking. The needle tip was inserted with a puncture to the level of subcutaneous fat and was dragged along the incision line with skin held under tension. With this method, we found that the epidermal and dermal burn was minimal hence obviating the need for vasoconstrictors. The microneedle cautery causes less necrosis than standard electrocautery tip, and the histological response is close to that of the cold scalpel [6, 7, 8]. Although the use of microdissection needle seems advantageous, caution should be excised to prevent inadvertent injury to vascular structure and needle stick injuries.
Conclusion
We conclude to state that the use of microdissection needle proves to be advantageous in terms of intraoperative blood loss and provides acceptable cosmesis.
Funding
We confirm that this study was not funded by any organization.
Compliance with Ethical Standards
Conflict of interest
The authors declare that they have no conflict of interest.
Footnotes
Publisher's Note
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