Evaluation of postoperative outcomes of advanced electrosurgical devices versus conventional clamp and tie technique for neck dissection- A randomized control study

Evaluation of Postoperative outcomes of Advanced electrosurgical devices v/s conventional clamp and tie technique for neck dissection

 BACKGROUND AND RATIONALE

Oral cancer is an important health issue in India as it is one of the most common types of cancer affecting a large population. Globally, oral cancer is the 6th most common type of cancer.  The global incidence of lip, oral cavity, and pharyngeal cancers is 529,500, which represents about 3.8% of all the cancer cases. This incidence is predicted to rise by 62% to 856,000 cases by the year 2035 because of changes in demographics.1 In India, around 77,000 new cases and 52,000 deaths are reported annually. Among the various head-and-neck subsites, global trends suggest, oral tongue as the most common subsite to be affected by squamous cell carcinomas.2 The inaccuracy of clinical examination and imaging to reliably detect occult cervical lymph node micrometastasis, along with the evidence from randomized clinical trials has resulted in elective neck dissections (END) becoming the standard of care for the vast majority of patients with early-stage oral squamous cell carcinomas (OSCCs).3  Approximately 40% of them occur in the oral cavity, 15% in the pharynx, 25% in larynx and 20% at other anatomical sites. 2,3

Neck dissection (ND) has been established as one of the most important surgical procedures for head and neck cancer since the 19th century. It is reported that the rate of complications ND ranges from 6% to 28%. Oral cancer is considered as an international health disease that affects an individual’s health, psychology, lifestyle, and loads the whole family with its effect. On the other hand, these kinds of diseases load the governments as well with economical overheads including the need for developmental programs and advanced research groups and centers.6-8

 Over the last two decades, various energy-based devices (EBDs) have been developed to achieve surgical hemostasis. EBDs enable operative time to be reduced through sutureless vessel ligation without increasing postoperative complications. EBDs are also superior to traditional methods with regard to hospital stay, blood loss, postoperative drainage, and pain.9-13 In neck surgery, and particularly in thyroid surgery, the most popular EBDs include the advanced bipolar LigaSureâ„¢ clamp (Covidien, Boulder, CO, USA) and the ultrasonic Harmonic Focus® scalpel (Ethicon Endo-Surgery, Cincinnati, OH, USA).10

A new hybrid system, the Thunderbeatâ„¢ (Olympus, Japan), was initially developed as a laparoscopic device, and combines and improves upon the harmonic and radiofrequency technologies. This new device has two blades, the active blade works as a harmonic scalpel, and at the same time, as one of the two bipolar electrodes, while the inactive blade acts as the other bipolar electrode. Thunderbeat is multifunctional, enabling the surgeon to coagulate (including large blood vessels up to 7mm in diameter) and cut in a single step, thereby reducing the need for instrument exchange. The Thunderbeat Open Fine Jaw (TB) has been designed for open surgical procedures that require delicate and fine tissue dissection, such as thyroidectomy and various ENT procedures.14

 Head and neck surgery by means of EBDs is gaining in popularity, few studies have specifically analyzed the outcomes of head and neck surgery with EBDs. Some recent reports have indicated the safety and efficacy of EBDs in thyroid surgery, and using EBDs can reduce operative time and intraoperative blood loss without increasing postoperative complications.15

EBD vs CONVENTIONAL CLAMP-TIE :

•      Various EBD are currently in use for achieving hemostasis during surgeries

•      EBD enable surgeons to achieve faster hemostasis, reduce intra-operative blood loss and eventually lead to decreased intra-operative time and decrease patient morbidity and mortality and decreased hospital stay.

•      However, EBD also lead to intraoperative complications and injury to surrounding sensitive structures, such as nerve injuries and vascular injuries

 What do we need to achieve?

1.     Follow-up data on post-operative status – eg. Morbidity in ND using EBD vs Conventional cut and tie method

2.     Correlation With Newer Coagulation Techniques Such As Thunderbeat, Harmonic, Advanced Bipolar And Using <10 Sutures.

AIMS AND OBJECTIVES

Aim

•      Do energy-based devices and clamp-tie techniques make any difference in the outcome of neck dissection in oral cancer?

Objective

•      Comparison of outcomes of neck dissection in  Oral Cancer using Energy Based Devices (advanced bipolar, Harmonic, Thunderbeat) v/s conventional clamp-tie technique.

•      Outcomes- blood loss, operative time, hospital stay.

   STUDY SETTING: The study will conducted in Department of General Surgery, King George’s Medical University, Lucknow, India

 STUDY PERIOD: 2 YEARS

  TYPE OF STUDY:

Prospective study

SAMPLE SIZE

Sample size – 60 (30 for each group)

Sample Size at 90% Power:

Sample size is calculated on the basis of maximum and minimum variation in dissection time using the formula.

Where ó1 = 68.0, The minimum half range of dissection time among the groups

ó2 = 76.5,  The maximum half range of dissection time among the groups

(Ref. Kensuke Suzuki, Minaki Shimizu, Tomofumi Sakagami, Masao Yagi, Takuo Fujisawa, Shunsuke Sawada, Akira Kanda, Yoshiki Kobayashi, Hiroshi Iwai, A comparison of short-term outcomes of neck dissection for head and neck cancers using Thunderbeat,  LigaSure or treatment without an energy-based device: A case-controlled study, International Journal of Surgery, Volume 58, 2018, Pages 60-64)

d = min(ó1, ó2), the difference considered to be clinically significant

k = 1.0 the design effect

type I error α = 5% corresponding to 95% confidence level

type II error β = 10% for detecting results with 90% power of study

So the required sample size    n = 30 each group

Statistical Analysis :

SPSS latest available version and MS Excel will be use for statistical analysis of the data. Continuous variables conforming to a normal distribution will be expressed as mean ± standard deviation. Counting data will be expressed as number and percentages. The unpaired t test/ANOVA or non parametric equivalents will be used for inter-group and intragroup analyses. The χ2 test will used to compare the proportion data between the groups. Other appropriate statistical tests will be used. In all of the statistical analyses, P < 0.05 will be considered to be statistically significant.

•      INCLUSION CRITERIA:

–     Patients having Oral Squamous cell carcinoma

–     Patient giving written informed consent

–     Patients above 18 years of age

•      EXCLUSION CRITERIA:

–     Patients not giving consent

–     Patient below 18 years of age

–     Patient already operated for Oral cancer (Recurrent cases) or already undergone neck dissection

–     Patients Post NACT of Oral carcinoma

–     Patient having Distant metastasis

METHODOLOGY

Study design: This would be a Prospective study.

It will be sent for approval to the Institutional Ethical Clearance Committee of the King George’s Medical University, Lucknow, India

 Patient Characteristics:

Thereafter patients were selected who were above 18 years of age and had oral squamous cell carcinoma.

 Consent: Written and informed consent would be taken from the Patient prior to inclusion of them in the study.

•      All patients will be divided into two groups:

–     ND without EBDs except conventional electrocautery (control group),

–     ND using the LS and TB

•      All enrolled patients will be all operated on with the LS or without EBDs.

•      TB became available for open surgery  and it was gradually and  used in the majority of cases  experienced surgeon performed by all.

Procedures

•      Specimen as the dissection time for each side of the neck.

•      In patients undergoing en bloc resection with the primary tumor, the completion of ND was defined as the time at which the dissected specimen was almost released from the surrounding structures.

•      All operations were recorded by video tape recorder, and at least two investigators measured and confirmed the dissection time for each ND. For this study, data will be collected evaluated in terms of the following potential confounders:

•       age (categorized into two groups: less than 70 years or 70 years and over),

•      gender (male or female), primary site (oral or other), extent of ND (3 or fewer levels or 4–5 levels), pathological nodal metastasis (negative or positive), extracapsular invasion (negative

Statistical Analysis:

Statistical analysis of the data will be performed with a Software program (SPSS, version 26.0, IBM, Chicago, Illinois).  Values will be presented as the mean ± SD.

The Chi-square test will be used to evaluate relationships between categorical variables. Differences will be considered significant at P<0.05.

REVIEW OF LITERATURE:

Walen SG  et al (2011) conducted a prospective randomized controlled study a single, tertiary care institution (Foothills Medical Centre) in Calgary, Alberta, Canada. A total of 31 patients (36 neck dissections) were prospectively enrolled between January 2009 and March 2010. Patients were randomized to receive a neck dissection with either the harmonic scalpel or the traditional technique of using electrocautery and sharp dissection. The study included adult patients older than age 18 years diagnosed with HNSCC and who required an SND (levels I-IV). Study exclusion criteria included previous treatment for head and neck cancer and all patients unwilling or unable to provide informed consent. Primary clinical outcomes were intraoperative blood loss and operative time. Secondary outcomes included intraoperative complications and surgical drain output. Intraoperative blood loss was significantly lower in the harmonic scalpel group compared to the traditional group (158 vs 61 mL, P = .02). There was no difference in operative time (81 minutes harmonic vs 85 minutes traditional) or total drain output (at both 48 hours and 1 week) between the groups. There were no intraoperative complications reported in either group. Results from this study suggest that the harmonic scalpel can reduce blood loss during SND for HNSCC. The harmonic scalpel had no impact on operative time, postoperative drain output, or complication rate.

 Ferri E,  et al (2013) conducted a prospective randomized trial was to compare operative factors, postoperative outcomes, and surgical complications of neck dissection (ND) when using the harmonic scalpel (HS) versus conventional haemostasis (CH) (classic technique of tying and knots, resorbable ligature, and bipolar diathermy). Total Sixty-one patients who underwent ND with primary head and neck cancer (HNSCC) resection were enrolled in this study and were randomized into two homogeneous groups: CH (conventional haemostasis with classic technique of tying and knots, resorbable ligature, and bipolar diathermy) and HS (haemostasis with harmonic scalpel). Outcomes of the study included operative time, intraoperative blood loss, drainage volume, postoperative pain, hospital stay, and incidence of intraoperative and postoperative complications. The use of the HS reduced significantly the operating time, the intraoperative blood loss, the postoperative pain, and the volume of drainage. No significant difference was observed in mean hospital stay and perioperative, and postoperative complications. The HS is a reliable and safe tool for reducing intraoperative blood loss, operative time, volume of drainage and postoperative pain in patients undergoing ND for HNSCC. Multicenter randomized studies need to be done to confirm the advantages of this technique and to evaluate the cost-benefit ratio.

Ren ZH  et al (2015) conducted a Randomized controlled trials (RCTs) were identified from the electronic databases (MEDLINE, EMBASE and Cochrane Library) using the keywords ‘‘harmonic scalpel’’ and ‘‘neck dissection,’’ and a quantitative meta-analysis done. The operative time and intraoperative bleeding were the primary outcome measures, and other parameters assessed included the drainage fluid volume and length of hospital stay. Seven trials that met the inclusion criteria included 406 neck dissection cases (201 in the harmonic scalpel group). Compared with conventional surgical techniques, the HS group had an operative time that was significantly reduced by 29.3 minutes [mean difference: -29.29; 95% CI = (-44.26, -14.32); P=0.0001], a reduction in intraoperative bleeding by 141.1 milliliters [mean difference: -141.13; 95% CI = (-314.99, 32.73); P=0.11], and a reduction in drainage fluid volume by 64.9 milliliters [mean difference: -64.86; 95% CI = (-110.40, -19.32); P=0.005] , but it is not significant after removal of studies driving heterogeneity. There was no significant difference in the length of the hospital stay [mean difference: -0.21; 95% CI = (-0.48, 0.07); P=0.14]. This study showed that using the harmonic scalpel for neck dissection significantly reduces the operative time and drainage fluid volume and that it is not associated with an increased length of hospital stay or perioperative complications. Therefore, the harmonic scalpel method is safe and effective for neck dissection. However, the statistical heterogeneity was high. Further studies are required to substantiate our findings.

Verma RK et al (2017) conducted a study that total 40 patients undergoing selective neck dissection for primary oral cavity malignancy were enrolled in this study. The harmonic scalpel (HS) group consisted of 20 patients, and the electrocautery technique (ET) group comprised of 20 patients. The following variables were examined: intraoperative blood loss, operative time, number of ligatures used, postoperative drain, and postoperative hospital stay. Intraoperative blood loss was found to be significantly reduced in harmonic scalpel group as compared to electrocautery group. However, we found no difference in other parameters like operative time, postop drain, postoperative hospital stay and number of ligatures used between both groups. Harmonic scalpel for neck dissection is associated with significantly lesser intraoperative blood loss as compared to electrocautery. There is no effect on operative time and postoperative hospital stay in both groups.

Suzuki et al (2018) conducted a retrospectively examined total 95 consecutive patients who underwent ND for head and neck squamous cell carcinoma between April 2013 and March 2018. The patients were divided into three groups: ND without the energy-based device (control group), ND using the LigaSure Small Jaw (LS group), and ND using the Thunderbeat Open Fine Jaw (TB group). The outcomes were compared among the three groups, as measured by the duration of ND (dissection time), blood loss during ND, and postoperative complications. We also analyzed the factors that may influence dissection time using multivariate analysis.  Compared to the control group, dissection time was found to be significantly shorter in both energy-based device groups (LS group and TB group) (96.4, 71.1, and 66.0 min, respectively, p = 0.0015) by univariate analysis. Blood loss during ND did not differ significantly among the three groups. Multivariate analysis showed that ND using the Thunderbeat as well as elderly patients (70 years and over), less extensive surgery (3 or fewer neck levels), and absence of extracapsular invasion were independently and significantly associated with shorter dissection time (p = 0.0069, 0.0337, <0.0001, and 0.0015, respectively). The incidence of postoperative complications in the LS group (20%) tended to be higher than those in the other groups (5.6% in the control group and 3.4% in the TB group), although the differences were not significant.  ND for head and neck cancers using the Thunderbeat is a safe and reliable method in terms of duration of dissection without increasing postoperative complications.

Chen TY et al (2021) studied those two authors for relevant articles comparing the outcomes of conventional and LSJ-assisted neck dissection. Data from each study were extracted, and a random-effects model was used in the pooled analysis. Compared with conventional techniques, LSJ-assisted neck dissection was associated with a significantly reduced operative time. The rates of postoperative hematoma, infection, amount of intraoperative blood loss, the length of hospital stay and the drainage amount showed no significant intergroup differences. The meta-analysis provides evidence that properly using LSJ may reduce the operative time compared with that of conventional techniques. Surgeons may consider using LSJ in neck dissection according to personal experiences.

Vaira et al (2021) conducted a study that total 48 patients undergoing unilateral neck dissection were divided into two groups. In one group, surgery was performed using conventional hemostatic instruments while in the other, only harmonic instruments were used. The two techniques were then compared with regard to intra- and post-operative blood loss, complications in operating time, drain, tracheotomy and nasogastric tube duration, and post-operative hospital stay.  Differences in operative time (P = 0.647), total suction drainage (P = 0.362) and time that drains (P = 0.404), nasogastric tube (P = 0.378), and tracheotomy (P = 0.052) were kept in place and proved not significant. The average blood loss during surgery was significantly greater in the CH group (P = 0.003) as the number of hemoclips and resorbable ligature used (P = 0.002).  In contrast to what has been reported up to now, our study did not reveal a net advantage in the use of harmonic instruments with respect to classical instruments in terms of surgical outcome. On the contrary, harmonic tools had a higher complication rate (i.e., salivary fistula and lymphatic leak) probably due to the decreased ability of this instruments to permanently close glandular structures and lymphatic ducts. In these cases, a closure technique such as electrocautery or classic knot-tying should be used.

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