Thulium laser versus cold steel tonsillectomy with bipolar electrocautery: a prospective pilot study in adult patients

doi:10.21203/rs.3.rs-2439572/v1

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Thulium laser versus cold steel tonsillectomy with bipolar electrocautery: a prospective pilot study in adult patients

https://doi.org/10.21203/rs.3.rs-2439572/v1

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Objectives

Multiple surgical techniques and instruments with their advantages and disadvantages have been described to minimize intraoperative hemorrhage and reduce the operation time, postoperative pain, and incidence of comorbidities in patients undergoing tonsillectomy. The aim of this pilot study was to compare the operation time, intraoperative and postoperative bleeding, postoperative pain and wound healing of the Thulium Revolix laser tonsillectomy method over the more commonly practiced cold steel tonsillectomy.

Methods

A prospective, single-blinded randomized pilot trial was conducted from February 2020 to March 2021. The inclusion criteria were adult persons with chronic recurrent tonsillitis. Twelve adult persons (7 males and 5 females) with chronic recurrent tonsillitis were observed and underwent tonsillectomy. All persons were Armenians with a mean age of 28.7 years. The persons were randomly assigned to have one tonsil removed with a Thulium RevoLix laser 200, and the conventional cold steel tonsillectomy method was used for the other side. The operation time for each side and intraoperational bleeding were evaluated. On the second, fifth, seventh and twelfth days, pain intensity was recorded using the numeric rating pain scale, and wound healing was assessed clinically.

Results

The tonsillectomy time from incision to hemostasis was 12.08 ± 0.77 min with the laser method and 12.08 ± 0.77 min with the cold dissection method, with no statistically significant difference (P < 0.121). Intraoperative blood loss in the cold dissection method was 10.92 ± 1.31 ml, and absolutely no blood loss was observed during laser treatment (p < 0.000, t = 8.363). The highest NRS pain scores were revealed on the second postoperative day, which slightly decreased over the next 12 postoperative days in both groups. In the cold steel tonsillectomy group, the pain score was significantly higher than that in the laser tonsillectomy group on the 7th and 12th postoperative days: 1.67 ± 0.33 via 4.00 ± 0.69 (P = 0.006) on the 7th postoperative day and 0.17 ± 0.11 via 2.67 ± 0.73 (P = 0.003) on the 12th postoperative day.

Conclusion

The use of the RevoLix 200 laser for tonsillectomy in the present pilot study of 12 patients showed significantly better outcomes than those in conventional cold dissection methods in terms of intraoperative bleeding, postoperative pain and wound healing; however, there was no statistically significant difference in other parameters, such as operational time and late postoperative bleeding. A large full-scale prospective study is needed to increase the generalizability and reliability of the results.

Clinical trial registration: ISRCTN16280803 https://www.isrctn.com/ISRCTN16280803

Surgery

Tonsillectomy

thulium laser

RevoLix 200

cold steel dissection

Tonsillectomy is one of the most common surgical procedures performed by otolaryngologists, with the number of tonsillectomies performed per year increasing over recent decades.^1–4

Indications for tonsillectomy in adults include chronic or recurrent tonsillitis, airway obstruction due to hypertrophied tonsils or any other suspicious tumors of the tonsils.^3,5,6

Multiple surgical techniques and instruments with their advantages and disadvantages have been described to minimize intraoperative hemorrhage and reduce the operation time, postoperative pain, and incidence of comorbidities in patients undergoing tonsillectomy.^2,6−12 The most common complications of the procedure are intraoperational bleeding, postoperative bleeding and pain.^13–16

Cold dissection is the most commonly used tonsillectomy technique, with low postoperative hemorrhage rates.¹⁷ Cold methods include dissection, guillotine, partial tonsillectomy with microdebrider, harmonic scalpel, plasma mediated ablation and cryosurgery.¹⁸ In hot dissection, an instrument delivers thermal energy to dissect the peritonsillar space (electrosurgery, coblation, radio frequency ablation and laser ablation). Coblation and laser surgeries are some of the more recent techniques for tonsillectomy.¹⁹

To compare the rates of major complications, a comparative study between the various methods of tonsillectomy was performed.^{2,5,10,12,18,20,21} It is considered that hot tonsillectomy causes more postoperative pain but less bleeding perioperatively and has a lower operative time.¹⁸ Of the available hot techniques, laser tonsillectomy has emerged as a new procedure, and the outcomes following laser surgery in recent years suggest an overall improvement.^8,20,22

Although numerous articles have been published in general surgery and urology on the use of thulium lasers,^23,24 very few otolaryngology studies are available that specifically address its use for tonsillectomy and compare it with other methods of tonsillectomy. In many studies, researchers have stated that the use of thulium lasers is safe and effective.^23,24

The aim of this pilot study was to compare the operation time, intraoperative and postoperative bleeding, postoperative pain and wound healing of the thulium revolix laser method with those of the more commonly practiced cold steel tonsillectomy.

The prospective, single-blinded randomized pilot trial was conducted from February 2020 to March 2021. The persons were recruited by physician referral from the ENT and Maxillofacial Surgery Department of “Heratsi” №1 University Hospital in Yerevan, Republic of Armenia. The persons with chronic recurrent tonsillitis in remission, who suspected for tonsillectomy, were informed by physician about ongoing trial. For avoiding self-selection bias the different method of tonsillectomy was blindly randomly selected for the same person for the left or right side.

Informed consent was obtained from all participants after providing written and oral information about the study. The study protocol was approved by the Ethics Committee of Yerevan State Medical University, and the trial “A pilot study of Thulium RevoLix laser usage for tonsillectomy” was registered in ISRCTN 16280803 (IRB no. YSMU N 6 − 1/2020).

The inclusion criteria were adult persons with chronic recurrent tonsillitis. Twelve adult persons (7 males and 5 females) with chronic recurrent tonsillitis were observed and underwent tonsillectomy. Sample size was calculated twice based on power (1-β = 0.8) and alfa 0.05, standard deviations and desirable observed differences for intraoperation time (estimated size 10 people) and bleeding (estimated size 11). With some precaution we select sample sizes of n = 12 persons. All participants provided informed consent for trial participation after providing written and oral information about the study. All persons were Armenians with a mean age of 28.7 years (range, 17–42 years). All tonsillectomies were performed by the same surgeon.

The exclusion criteria were as follows: 1) bleeding diathesis, 2) poor anesthetic risk, 3) uncontrolled medical illness, 4) anemia, or 5) acute infection.

All necessary diagnostic examinations were performed before the operation (blood analysis, urine analysis, chest XR, ECG, anesthesiologist examination). All recruited persons underwent surgery under general anesthesia by the same surgeon.

The method of removal of each tonsil was blindly randomly assigned to have one tonsil removed with a Thulium RevoLix laser 200, and the conventional cold steel tonsillectomy method was used for the other side. The Thilium RevoLix laser 200 has a wavelength of 2.0 microns and is used for incision and vaporization. The RevoLix laser beam is delivered by flexible laser fibers. A power of 8 W was used for laser tonsillectomy in all cases.

The hospital stay was 2–4 days for all persons, with an outpatient follow-up of 12 days. The end of participation was elected on the 13th postoperative day. All patients used the same medications for 12 postoperative days. Outcome measures included:

Intraoperative blood loss quantified by measuring suction bottle fluid and weight measurement of surgical sponges
Time taken for surgery, which was measured from the beginning and finishing of tonsillectomy on each side
Postoperative pain was measured by a numerical rating scale (NRS) from 0–10 at 2, 5, 7 and 10 days postoperatively.
Postoperative bleeding was assessed by the effectiveness of the management strategy (no therapy, clot suction, direct pressure or electrocautery).
Time taken for complete healing was compared on both tonsillectomy sides by serial direct clinical examinations at 5, 7 and 12 days postoperatively.

Statistical analysis was performed using the SPSS 16.0 statistical package. Normal distribution of data was assessed using the Kolmogorov Smirnov test. For comparison of means if data were normally distributed, independent samples, two-sided Student’s t test was applied. For analyses of intraoperative blood loss, a one-sample t test was performed. In the case of asymmetric distribution (only PLas day 12), a nonparametric two-sided Mann Whitney test was used. In all cases, differences were considered significant at the p < 0.05 level.

The tonsillectomy time from incision to hemostasis was 12.08 ± 0.77 (SE) min with the laser method and 12.08 ± 0.77 (SE) min with the cold dissection method, with no statistically significant difference (P = 0.121) (n = 12; two-sided two independent group t-test) (Table 1). Intraoperative blood loss in the cold dissection method was 10.92 ± 1.31 ml (SE), and absolutely no blood loss was observed during laser treatment (p < 0.001, one group two-sided t-test; t = 8.363; n = 12) (Table 2).

Table 1

Time taken for surgery.
Patient number (n = 12)	Laser tonsillectomy (min)	Cold steel tonsillectomy (min)
1	10	6
2	16	8
3	16	11
4	12	6
5	10	8
6	15	10
7	12	7
8	15	10
9	9	14
10	10	15
11	10	15
12	10	15
Mean value ± SE	12.08 ± 0.77	10.92 ± 1.31
P = 0.121 (two-sided two independent group t-test)

Table 2

Intraoperative blood loss in both groups.
Patient number (n = 12)	Laser tonsillectomy (ml)	Cold steel tonsillectomy (ml)
1	0.0	8
2	0.0	6
3	0.0	10
4	0.0	7
5	0.0	7
6	0.0	8
7	0.0	10
8	0.0	10
9	0.0	20
10	0.0	18
11	0.0	15
12	0.0	12
Mean value ± SE	0.0	10.92 ± 1.31
p < 0.001, t = 8.363 (one group two-sided t-test)

On the second, fifth, seventh and twelfth days, pain intensity was recorded using the numeric rating pain scale. The mean pain severity on the second day after surgery was 5.7 ± 0.54 (SE) on the laser side and 7.25 ± 0.46 (SE) on the cold dissection side, with a significant difference (P = 0.037; n = 12). No significant difference was found between pain intensity on the fifth day after surgery between the laser (3.9 ± 0.49; SE) and cold dissection (5.58 ± 0.66; SE) methods (P = 0.055; n = 12). On the seventh and twelfth postoperative days, the pain severity decreased on both sides, but laser tonsillectomy showed significantly lower pain severity values than cold steel dissection Table 3.

Table 3

Postoperative pain in both groups, NRS, (n = 12).
Post-op days	Laser tonsillectomy (n = 12) Mean ± SE	Cold steel tonsillectomy (n = 12) Mean ± SE	Two-sided t test P value
2nd day	5.7 ± 0.54	7.25 ± 0.46	P = 0.037
5th day	3.9 ± 0.49	5.58 ± 0.66	P = 0.055
7th day	1.67 ± 0.33	4.00 ± 0.69	P = 0.006
12th day	0.17 ± 0.11	2.67 ± 0.73	P = 0.003

No significant difference was detected in the comparison of the patients' sex with bleeding rate during surgery and pain intensity after surgery.

No postoperative bleeding was observed on either side in the postoperative period; thus, there was no need for any management.

Wound healing was assessed visually on the 5th, 7th and 12th postoperative days. On the fifth postoperative day the laser tonsillectomy sides, the fibrin plaque was softer and less remarkable. On the cold steel tonsillectomy sides, the fibrin plaque was whitish and more pronounced (Fig. 1).

On the 7th postoperative day, on the laser tonsillectomy side, the fibrin plaque somewhere was sloughing off and covered with newly formed epithelial tissue. On the cold dissection sides, the fibrin plaque was somewhat sloughed off and had somewhat of a green-gray color (Fig. 2).

On the 12th postoperative day, on the hot dissection side, almost full epithelization was observed. On the cold dissection side, fibrin plaques existed in some islands, and the main surface was closed with newly formed epithelial tissue (Fig. 3).

Tonsillectomy is one of the most common surgeries in the field of otolaryngology and is frequently performed to resolve recurrent tonsillitis or upper respiratory tract obstruction due to tonsillar hypertrophy.^1,5,6,12,22

Many methods of tonsil removal are described in the literature, and the main goal of new research methods and their clinical implications are to reduce intraoperational and postoperative complication rates.^3,22 To date, tonsillar surgery and its indications and techniques continue to evolve.¹⁸ There are a number of tonsillectomy techniques, and they can be grouped as cold and hot. Technological innovations are focused on a bloodless surgical field, less operative time, less postoperative pain, an improved healing rate, affordability and safety.¹⁸ There is a great debate about the relative advantages of various techniques.^{4,6,10,11,12,22} The equipment involved with various techniques varies in price, although the important cost factor in tonsillectomy is the operating time.¹⁸

Cold dissection is the most commonly used tonsillectomy technique and is still the most practiced method, especially in the developing world.^17,18 In this method, stainless steel scissors and scalpels, toothed forceps and a herd dissector/retractor are used to dissect the whole tonsil tissue from its capsule and expose the underlying constrictor muscles.¹⁸

Of the available hot techniques, laser tonsillectomy has emerged as a new procedure.⁸ In 1994, Krespi and Ling²⁵ introduced the concept of bloodless tonsillectomy with a laser. The CO2 laser, an excellent cutter, has a valuable role in otolaryngological practice. Linder et al.⁹ in 1999 advocated the use of lasers for tonsillotomy, especially in children with large tonsils. It causes less bleeding, less pain, and discomfort and is a day care procedure. However, more secondary hemorrhage and postoperative pain were noted with the laser. Hegazy et al.,²⁰ in their pilot comparison study between potassium titanyl phosphate laser and bipolar radiofrequency, revealed that the laser reduced operative bleeding and avoided immediate postoperative pain when compared with the bipolar radiofrequency technique. However, potassium titanyl phosphate laser required slightly more operative time and caused more late postoperative pain.

RevoLix was specifically developed for soft tissue surgery. The RevoLix laser wavelength is 2 microns. This wavelength is similar to holmium, but the emission is continuous instead of pulsed. The RevoLix laser beam is delivered by flexible laser fibers. Incision and vaporization of tissue is similar to CO2 laser technology. This is ideal for endoscopic, laparoscopic, open and minimally invasive surgery. RevoLix provides the highest tissue vaporization rate published. Unlike green lasers, the RevoLix vaporization efficiency does not decrease during surgery because the absorbing chromophore is water, and the effect of the laser on tissue is independent of tissue vascularization.^26,27 Excess laser radiation does not affect tissue more than 3 mm from the tip of the fiber tip. The optical penetration of RevoLix in tissue is app. 0.25 mm.²⁴

Tissue damage was limited to 0.2 to 1.0 mm. Visualization is excellent. Neither bleeding nor visible laser glare affects the vision of the surgical site.^24,26,27

In the present study, the mean surgery time for the RevoLix laser technique was 12.08 ± 0.77 (SE) min minutes (range, 9.0–16.0 minutes), which is nonsignificantly longer than that for cold steel tonsillectomy (10.92 ± 1.31 (SE) min., range 6.00–15.00 min, P = 0.121).

The most common complication of tonsillectomy is bleeding during or after surgery.^15,16 Despite the surgeon’s most sophisticated efforts to prevent it, hemorrhage remains the most significant complication after tonsillectomy.^13,15,16 Windfuhr et al.¹ reported that the rate of primary hemorrhage (within 24 h of surgery) ranged from 0.2 to 2.2%, whereas secondary hemorrhage (24 h after surgery) ranged from 0.1 to 3%. In 2006, the National Institute of Clinical Excellence declared its position on laser tonsillectomy reporting that bleeding may be less intraoperatively but is more postoperatively, that initial pain may be less but medium term is more and that healing is delayed.⁸

Ahmed and Arya ⁸ performed systematic reviews and meta-analyses comparing laser tonsil surgery with other techniques, and a total of 14 articles were evaluated. A variety of laser techniques were used, including CO2 (66%), potassium-titanyl-phosphate (19%) and contact diodes (15%). Nonlaser techniques included dissection (62%), diathermy (20%), and coblation (18%). The summated conclusions suggest that laser techniques are superior regarding intraoperative bleeding and procedure duration. Laser techniques also provide equivocal or superior outcomes regarding postoperative hemorrhage, pain, and total healing time. In the present study, there was no intraoperational bleeding at all in laser surgery, and the mean bleeding in cold steel tonsillectomy was 10.92 ± 1.31 ml (SE) (Min 6 ml, Max 20 ml). There was no case of postoperative bleeding in the presented study patients.

Pain is an unpleasant and distressing complex and subjective phenomenon with emotional experience.

The feeling of pain depends upon the pain threshold of the person, damage done and emotional and psychological setup. Most emotional and psychologically stable patients have high pain threshold levels and hence feel less pain. If the nerve endings are not exposed, the vascularity of the nerve ending is maintained, and it is likely that the patient will feel less/minimal pain.¹⁸

Local pain after the operation is a major drawback of tonsillectomy. However, Wiltshire et al.¹¹ reported a remarkable alleviation in postoperative pain and a faster return to normal food intake with coblation. Some other studies have since shown varying results. Arbin et al.⁷ reported no significant difference in pain scores among 60 patients who underwent either bipolar diathermy scissors tonsillectomy (higher temperature dissection) or harmonic scalpel tonsillectomy (lower temperature dissection). However, Hegazy et al.²⁰ found that potassium titanyl phosphate laser avoided immediate postoperative pain when compared with the bipolar radiofrequency technique but caused more late postoperative pain.

In the present pilot study, the highest NRS pain scores were revealed in the second postop day, which slightly decreased over the next 12 postop days in both groups. In the cold steel tonsillectomy group, the pain score was significantly higher than that in the laser tonsillectomy group on the 7th and 12th postoperative days: 1.67 ± 0.33 via 4.00 ± 0.69 (SE) (P = 0.006; n = 12) on the 7th postoperative day and 0.17 ± 0.11 via 2.67 ± 0.73 (SE) (P = 0.003; n = 12) on the 12th postoperative day.

Piitulainen et al.⁴ defined the duration of postoperative recovery to be dependent on three endpoints: pain at rest, pain on swallowing and the regular use of analgesics. In the present study, wound repair was assessed by the time taken for complete healing, and both tonsillectomy sides were compared by serial direct clinical examinations at 5, 7 and 12 postoperative days.

Only a few studies have compared wound healing after different tonsillectomy methods.^26,27 As noted Isaacson,²⁸ epithelial ingrowth beneath a fibrin clot begins shortly after wounding. Separation of the fibrin clot approximately 7 days after surgery exposes the vascular stroma. Involution of the vascular stroma and completion of epithelial coverage correlate with decreased pain levels and a reduced risk of bleeding. The tonsillar fossa healing in the present pilot study was faster on the laser tonsillectomy sides than on the cold dissection sides. On the 7th postoperative day on the laser tonsillectomy side, the fibrin layer partially sloughed off, and underlying tissue covered with newly formed epithelial tissue was observed. On the twelfth postop day, full epithelization of a tonsillar fossa was visualized on the laser dissection side. On the cold dissection side, the fibrin layer still existed in some islands, although the main surface was closed with newly formed epithelial tissue.

Study limitations

The study was performed in adult patients, but complementary studies are needed to confirm the use of this method as a standard protocol for tonsillectomy in all age groups. Despite the benefits of the RevoLix laser technique, the higher cost of the Thulium RevoLix 200 system should be considered. A large full-scale randomized controlled trial is needed to increase the generalizability and reliability of the results.

The presented pilot study can be used to evaluate the feasibility of recruitment, randomization, and retention, comparative assessment of proposed methods and implementation of the novel intervention with a thulium revolix laser.

The use of the RevoLix 200 laser for tonsillectomy in the present pilot study of 12 patients showed significantly better outcomes than those of conventional cold dissection methods in terms of intraoperative bleeding, postoperative pain and wound healing; however, there was no statistically significant difference in other parameters, such as operational time and late postoperative bleeding. A large full-scale prospective study is needed to increase the generalizability and reliability of the results.

Acknowledgments

We greatly acknowledge Dr. Garo M. Tertzakian for providing the RevoLix 200 thulium laser and technical support to <<Heratsi>>№1 hospital complex of YSMU.

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Conflict of interest statement

The authors have stated explicitly that there are no conflicts of interest in connection with this article.

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Thulium laser versus cold steel tonsillectomy with bipolar electrocautery: a prospective pilot study in adult patients

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Abstract

Objectives

Methods

Results

Conclusion

Figures

Introduction

Materials And Methods

Results

Discussion

Study limitations

Conclusion

Declarations

References

Status:

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