Abstract
Purpose
Argon plasma coagulation (APC) is a new surgical procedure based on a conductive plasma of ionized argon between an activating electrode and a tissue surface. It is a good alternative for tonsillectomy because of its effective hemostasis and limited penetration depth of the coagulation beam. The aim of this prospective, randomized trial was to evaluate the operative time, intraoperative bleeding, and postoperative morbidity of the “hot” APC tonsillectomy compared with a traditional “cold” dissection tonsillectomy in children.
Materials and Methods
Two hundred eighteen pediatric patients (aged 4-15 years; mean, 7,2 years) were randomized into 2 groups: treatment A (tonsillectomy with APC, n = 109) and treatment B (conventional tonsillectomy, n = 109). The outcome measures were as follows: (1) operative time, (2) intraoperative blood loss, (3) postoperative pain (evaluated using a visual analogue scale with a range score 0-10 on postoperative days 1, 3, 5, 8, and 15), and (4) postoperative primary and secondary hemorrhage. Statistical analysis was carried out using the Student t test.
Results
In treatment A group, the mean duration of operative time and the intraoperative blood loss were significantly reduced ( P < .001). There was no statistical significant difference between 2 groups in the intensity of postoperative pain and the incidence of postoperative hemorrhage ( P > .05).
Conclusions
Argon plasma coagulation tonsillectomy in children is a new, easy, and safe technique that offers a complete eradication of the tonsillar disease, short operating time, minimal intraoperative blood loss, and a suitable cost with no additional increase in postoperative pain and hemorrhage when compared with the conventional “cold dissection.”
1
Introduction
Argon plasma coagulation (APC), or argon plasma surgery, has been used successfully for more than 20 years for hemostasis of superficial hemorrhages and resection of parenchymatous tissue in open surgery, laparoscopy, and thoracoscopy . APC offers an innovative possibility for head and neck surgery because of its effective hemostasis and limited depth of the coagulation zone resulting from its superficial effects. The most frequent applications are in the endonasal region (reduction of hyperplastic turbinates, treatment of recurrent epistaxis, and telangiectasis), the endolaryngeal region (laryngotracheal papilloma, laryngeal stenosis, and granulomas), and the oropharyngeal region (tonsillectomy, resection of benign neoplasm of the oropharynx, and uvulopalatoplasty) .
Over the last few years, several different techniques for performing tonsillectomy have been proposed in the attempt to lower the morbidity of this surgery, especially in the children. Postoperative pain and hemorrhage are the issues, which are usually discussed comparing different surgical methods. However, operative time and intraoperative bleeding are also important parameters, especially in younger children. To date, there is no conclusive evidence in the literature as to which surgical technique is best for performing pediatric tonsillectomy.
We describe a randomized study that was designed to compare the APC tonsillectomy with the conventional “cold dissection” tonsillectomy in the pediatric patients, with regard to the following 4 outcome measures: (1) operative time, (2) intraoperative bleeding, (3) postoperative pain, and (4) postoperative primary or secondary hemorrhage.
2
Materials and methods
2.1
Equipment and principles of APC technique
The equipment used for APC surgery consists of an automatically regulated argon supply unit (Coagulator APC 300), a high-frequency generator (HF ERBOTOM ICC 350), and a set of rigid or flexible Teflon tube with a ceramic tip. The combination of the argon gas delivery with the primer of the high-frequency current determines the gas ionization and its emission through the distal end of the tube, where there is the electrode that represents one of the poles of the high-frequency voltage source. The other one is connected to the patient via a so-called “neutral” electrode. Provided that high-frequency voltage between the electrode in the argon applicator and the patient is adequate and the distance between the electrode and the tissue is small enough, the argon ionizes, forming electrically conductive argon plasma in the presence of an electric field of 500 V/mm. A light-blue, luminescent stream of argon plasma is created, permitting high-frequency current to be applied without contact to the treated tissue.
The argon plasma beam orients itself primarily to tissue locations where electrical conductivity is higher. Hence, the argon plasma automatically diverts from the areas that are already coagulated (which show a high level of electric resistance and a low level of conductivity) to reach the hemorrhagic areas (which show a low electric resistance and a high conductivity). In this way, the coagulation effect is homogeneous, regular, and self-limited. The depth of coagulation zone was evaluated to be an average of 1 to 2 mm. Coagulation zones below 2 mm can be maintained by controlling the output power of the high-frequency generator and the duration of the application. This prevents the tissue from carbonization and evaporation, an important advantage in comparison with mucosal lesion secondary to common hemostasis in the upper aerodigestive tract.
2.2
Patients, inclusion criteria, and operative technique
From February 2006 to February 2009, 218 consecutive pediatric patients undergoing bilateral tonsillectomy at the ENT Department of the General Hospital of Dolo (Venice) were recruited for a clinical prospective randomized study and were stratified in two groups: treatment A (TA; tonsillectomy performed with APC, n = 109) and treatment B (TB; conventional tonsillectomy performed with blunt dissection and bipolar coagulation, n = 109). The patients aged 4 to 15 years, with a mean age of 7.2 years; there were 122 men (56%) and 96 women (44%), with a male/female ratio of 1:0.78.
The study was approved by the local regional ethical committee. Patients and parents were given detailed information about the study, and informed consent was obtained. Patients could withdraw from the study at any time.
The indications for tonsillectomy were recurrent infections, chronic infection or history of recent peritonsillar abscess (not before one month), severe obstruction of airways with upper resistance, and mechanical dysphagia. Exclusion criteria included patients with significant comorbidities such as systemic disease, known bleeding diathesis, craniofacial disorders, chromosomal abnormalities, motor/developmental delay, and any significant chronic illness that would interfere with surgical treatment or expected recovery.
The two surgical groups were statistically similar as far as age and sex are concerned and were similarly distributed in terms of tonsil size. None of the patients received concurrent adenoidectomy.
All tonsillectomies were performed by the same surgical team, under general anesthesia using oral or nasal endotracheal intubation and a Boyle-Davis gag. Prophylactic antibiotic agents were not prescribed.
Conventional “cold dissection” tonsillectomy was started by an incision overlaying the superior pole of the tonsil. The “cold dissection” proceeded along the tonsillar fossa in the peritonsillar plane keeping as close to the tonsil capsule as possible. Hemostasis was achieved by the application of pressure with packs, and persistent bleeding was controlled by a bipolar diathermy coagulation of vessels.
Tonsillectomy with APC was initiated, grasping the superior pole of palatine fossa with the forceps. It was dissected under activation of the plasma beam with the APC Bergler’s dissector (“Raspatorium”) or with the semirigid Teflon tube used for uvulopalatoplasty. Bergler’s dissector is a specially shaped and designed instrument for argon surgery tonsillectomy; this instrument allows to perform dissection and coagulation in one step. On the lateral side of the ceramic tip of “Raspatorium” two suction channels for the aspiration of blood and smoke were included. In our experience, the semirigid Teflon tube used for uvulopalatoplasty is also able to perform argon plasma tonsillectomy with similar modality.
The peritonsillar plane was identified, and the tonsils were removed from the palatine fossa under continuous APC activation up to the lower pole. Dissection, coagulation, and hemostasis were done contemporary. In cases of remarkable vascularization secondary to chronic infection, the speed of dissection was decreased to permit adequate coagulation.
Surgical time was measured from the first incision until the hemostasis has been completed. The intraoperative blood loss was measured by weighing the tonsil swabs before and after tonsillectomy and by measuring the volume of blood in the suction system.
Assessment of postoperative pain had to be done using a visual analogue scale, with a range of 0 to 10 indicating “no pain” (index 0) and “worst possible pain” (index 10), respectively. All patients and/or parents were asked to record their own pain scores on postoperative days 1, 3, 5, 8, and 15.
Standardized pain control regime was used in all patients, which included codeine with paracetamol association (20 mg codeine phosphate and 400 mg paracetamol) every 8 hours. All patients were discharged home in the first postoperative day and were reviewed in 8th and 15th postoperative days.
Primary hemorrhage is defined as bleeding occurring within 24 hours of surgery; secondary hemorrhage is defined as bleeding occurring after 24 hours of surgery.
Statistical analysis was carried out using the Student t test. A P value of less than .05 was considered statistically significant.
2
Materials and methods
2.1
Equipment and principles of APC technique
The equipment used for APC surgery consists of an automatically regulated argon supply unit (Coagulator APC 300), a high-frequency generator (HF ERBOTOM ICC 350), and a set of rigid or flexible Teflon tube with a ceramic tip. The combination of the argon gas delivery with the primer of the high-frequency current determines the gas ionization and its emission through the distal end of the tube, where there is the electrode that represents one of the poles of the high-frequency voltage source. The other one is connected to the patient via a so-called “neutral” electrode. Provided that high-frequency voltage between the electrode in the argon applicator and the patient is adequate and the distance between the electrode and the tissue is small enough, the argon ionizes, forming electrically conductive argon plasma in the presence of an electric field of 500 V/mm. A light-blue, luminescent stream of argon plasma is created, permitting high-frequency current to be applied without contact to the treated tissue.
The argon plasma beam orients itself primarily to tissue locations where electrical conductivity is higher. Hence, the argon plasma automatically diverts from the areas that are already coagulated (which show a high level of electric resistance and a low level of conductivity) to reach the hemorrhagic areas (which show a low electric resistance and a high conductivity). In this way, the coagulation effect is homogeneous, regular, and self-limited. The depth of coagulation zone was evaluated to be an average of 1 to 2 mm. Coagulation zones below 2 mm can be maintained by controlling the output power of the high-frequency generator and the duration of the application. This prevents the tissue from carbonization and evaporation, an important advantage in comparison with mucosal lesion secondary to common hemostasis in the upper aerodigestive tract.
2.2
Patients, inclusion criteria, and operative technique
From February 2006 to February 2009, 218 consecutive pediatric patients undergoing bilateral tonsillectomy at the ENT Department of the General Hospital of Dolo (Venice) were recruited for a clinical prospective randomized study and were stratified in two groups: treatment A (TA; tonsillectomy performed with APC, n = 109) and treatment B (TB; conventional tonsillectomy performed with blunt dissection and bipolar coagulation, n = 109). The patients aged 4 to 15 years, with a mean age of 7.2 years; there were 122 men (56%) and 96 women (44%), with a male/female ratio of 1:0.78.
The study was approved by the local regional ethical committee. Patients and parents were given detailed information about the study, and informed consent was obtained. Patients could withdraw from the study at any time.
The indications for tonsillectomy were recurrent infections, chronic infection or history of recent peritonsillar abscess (not before one month), severe obstruction of airways with upper resistance, and mechanical dysphagia. Exclusion criteria included patients with significant comorbidities such as systemic disease, known bleeding diathesis, craniofacial disorders, chromosomal abnormalities, motor/developmental delay, and any significant chronic illness that would interfere with surgical treatment or expected recovery.
The two surgical groups were statistically similar as far as age and sex are concerned and were similarly distributed in terms of tonsil size. None of the patients received concurrent adenoidectomy.
All tonsillectomies were performed by the same surgical team, under general anesthesia using oral or nasal endotracheal intubation and a Boyle-Davis gag. Prophylactic antibiotic agents were not prescribed.
Conventional “cold dissection” tonsillectomy was started by an incision overlaying the superior pole of the tonsil. The “cold dissection” proceeded along the tonsillar fossa in the peritonsillar plane keeping as close to the tonsil capsule as possible. Hemostasis was achieved by the application of pressure with packs, and persistent bleeding was controlled by a bipolar diathermy coagulation of vessels.
Tonsillectomy with APC was initiated, grasping the superior pole of palatine fossa with the forceps. It was dissected under activation of the plasma beam with the APC Bergler’s dissector (“Raspatorium”) or with the semirigid Teflon tube used for uvulopalatoplasty. Bergler’s dissector is a specially shaped and designed instrument for argon surgery tonsillectomy; this instrument allows to perform dissection and coagulation in one step. On the lateral side of the ceramic tip of “Raspatorium” two suction channels for the aspiration of blood and smoke were included. In our experience, the semirigid Teflon tube used for uvulopalatoplasty is also able to perform argon plasma tonsillectomy with similar modality.
The peritonsillar plane was identified, and the tonsils were removed from the palatine fossa under continuous APC activation up to the lower pole. Dissection, coagulation, and hemostasis were done contemporary. In cases of remarkable vascularization secondary to chronic infection, the speed of dissection was decreased to permit adequate coagulation.
Surgical time was measured from the first incision until the hemostasis has been completed. The intraoperative blood loss was measured by weighing the tonsil swabs before and after tonsillectomy and by measuring the volume of blood in the suction system.
Assessment of postoperative pain had to be done using a visual analogue scale, with a range of 0 to 10 indicating “no pain” (index 0) and “worst possible pain” (index 10), respectively. All patients and/or parents were asked to record their own pain scores on postoperative days 1, 3, 5, 8, and 15.
Standardized pain control regime was used in all patients, which included codeine with paracetamol association (20 mg codeine phosphate and 400 mg paracetamol) every 8 hours. All patients were discharged home in the first postoperative day and were reviewed in 8th and 15th postoperative days.
Primary hemorrhage is defined as bleeding occurring within 24 hours of surgery; secondary hemorrhage is defined as bleeding occurring after 24 hours of surgery.
Statistical analysis was carried out using the Student t test. A P value of less than .05 was considered statistically significant.