2. Methods
bleeding, intraoperative bleeding, adenoid mass, failure of haemostasis, 53792/12, obstructive sleep apnea, ’s mouth, blood loss, postoperative bleeding, palate, coagulation abnormalities, hyperextension, postadenoidectomy haemorrhage, bipolar electrocautery
BLEEDING, GROUP B, OBSTRUCTIVE SLEEP APNEA, BLOOD LOSS, POSTOPERATIVE BLEEDING, NELATON, CHRONIC SEROUS OTITIS MEDIA, RECURRENT ACUTE OTITIS MEDIA, RECURRENT UPPER RESPIRATORY TRACT INFECTIONS, COLD, INTRAOPERATIVE BLEEDING
We conducted a prospective randomised controlled study in the ENT Department of a tertiary Children’s Hospital between November 2022 and January 2023, involving children undergoing adenoidectomy. The aim of our study was to assess the cause—effect relationship between an intervention (use of continuous suctioning during adenoidectomy) and outcome (duration of haemostasis, total operative time, intraoperative bleeding, and incidence of early postoperative bleeding).Our Hospital’s Ethics Committee has approved this clinical study (53792/12 December 2022). After explaining the procedures and objectives of the study, parents’ written consent was obtained in each case for preoperative blood tests, surgery, general anaesthesia, and inclusion in this study.In our study, patient records were anonymised, data were collected in an Excel database, and it was analysed. The investigators for this study introduced in the OR protocols for adenoidectomies the exact measurements of the operative time, haemostasis time, and number of gauze packings used intraoperatively for each adenoidectomy procedure. The use of bipolar electrocautery to complete haemostasis was recorded for each patient in their surgical protocol.Inclusion and exclusion criteria. 140 children were included in this study, divided into two groups. Children aged 0 to 18 years were enrolled if they met the following inclusion criteria: 1—child admitted to the Paediatric ENT Department of our hospital; 2—indication of adenoidectomy under general anaesthesia (due to obstructive sleep apnea or severe recurrent upper respiratory tract infections; recurrent acute otitis media or chronic serous otitis media); 3—laboratory tests (blood markers) performed preoperatively by our hospital’s laboratory with no major coagulation abnormalities reported; 4—simple adenoidectomy procedures performed between November 2022 and January 2023 by the same 3 ENT experienced consultants; 5—adenoidectomies performed only on 2 days per week (Wednesdays and Fridays) during the trial period.Adenoidectomies performed by any surgeon in the department on other weekdays were excluded. Adenoidectomies with myringotomy tube insertion or adenotonsillectomies were excluded from our study. Adenoidectomies performed by other surgeons, even if during the same 6-month period in the same department, were excluded.The two analysed groups were defined by the presence or absence of a specific intervention (use of continuous suctioning). Group A enrolled children for whom continuous suctioning was used at the end of the adenoidectomy procedure. Group B consisted of children in whom no continuous suctioning was used during an adenoidectomy. Children were randomly recruited by the leading investigator from children undergoing adenoidectomy in our department over a 6-month period and assigned randomly to one of the two groups.Patients were randomly assigned to groups A or B preoperatively. The leading investigator chose intervention days such that all enrolled surgeons used continuous suction on these specific days, while they used other haemostatic methods during the rest of the study (cotton packings, electrocautery). As a result, every surgeon out of the three participating in our study performed adenoidectomy with or without the application of continuous suctioning during this study period, but on different days. This was decided in order to eliminate bias and ensure the randomisation of the participants.All adenoidectomies were performed under general anaesthesia with orotracheal intubation by three different surgeons, consultants with over 15 years of similar surgical experience, using the same technique and identical equipment, as well as the same anaesthesia procedure. General anaesthesia was performed with sevoflurane induction, and maintenance is carried out accordingly with intravenous propofol along with sevoflurane as needed. After initial endoscopic evaluation of the child’s nasopharynx (drug-induced sleep endoscopy), classic cold instrument adenoidectomy was performed in all cases (Beckmann’s curette adenoidectomy technique) under direct vision (hyperextension of the child’s neck, unilateral Nelaton’s probe used to retract the soft palate anteriorly and cranially for enhanced direct visualisation of the nasopharynx). Digital palpation of the adenoid mass and nasopharynx was routinely performed prior to and after the procedure in order to ensure complete excision of the adenoid mass. Endoscopic control is always used to assist adenoidectomy when local anatomy makes the inspection of the child’s upper rhinopharynx (near the choanae) impossible. After complete resection of the adenoid mass, haemostasis follows these steps: a cotton packing is introduced in the nasopharynx twice (each left in place for a maximum of 1 min), then another packing is soaked in vasoconstrictor medication (epinephrine dilution 1/10), then direct irrigation with saline solution at room temperature (approximately 10 mL). In patients from group A, continuous suctioning via a metallic probe for 3–5 min was applied to the nasopharynx, set at 150 mbar/hPa. No action was taken in group B patients—cotton packings (without other haemostatic solutions) were used as needed until local bleeding stopped or the surgeon decided to use electrocautery for haemostasis.No other haemostatic materials such as hydrogen peroxide, xylometasoline, topical tranexamic acid, or fibrin-based haemostatic powder were used either in groups A or B to enhance haemostasis. In cases of failure of haemostasis (over 10 min of haemostasis duration, failure of the saline irrigation solutions to clear or localise persistent bleeding from the nasopharynx), the consequent minimal use of bipolar electrocautery to complete haemostasis was allowed. In our department, we use bipolar electrocautery at the lowest setting for coagulation for as short a time as possible, intermittently (at 30 W for a maximum of 2 s).After surgery, children were monitored in our intensive care unit next to the operating theatre for 20 min, until they were awake and stable, then returned to the clinical ward. Children are encouraged to start early oral intake of clear liquids. The adenoidectomy patient is then supervised for approximately 6 h before discharge. Patients living within 1 hs distance from the hospital are discharged on the same day if no early postoperative bleeding occurs and if they have successfully restarted oral feeding.Group A (continuous suctioning) enrolled 70 patients in whom continuous suctioning via a metallic probe with a perforated tip was used during adenoidectomy haemostasis. Group B enrolled 70 patients—in whom no continuous suctioning was used during haemostasis.Suctioning method. We typically use a large metallic tube with a wide tip (approximately 1 cm in diameter) and multiple orifices at its end; the instrument is used both for suctioning from the nasopharynx and as a tongue depressor (Outcome variables. Two of the investigators measured and recorded the studied variables in all the patients enrolled in this study: total operative time (time was measured beginning with the first surgical gesture, after retraction of the soft palate, until adenoidectomy completely ended and all instruments were retracted from the operated child’s nasopharynx), haemostasis time (defined as the time elapsed after complete excision of the adenoid mass to completion of surgery, when surgical instruments are entirely withdrawn from the child’s mouth and nose), and the number of cotton packings used intraoperatively (in order to assess semiquantitatively the blood loss; a packing is considered used if at least 80% soaked in blood). The need for electrocautery use was defined as failure of haemostasis (over 10 min of haemostatic time and/or intense localised and persistent bleeding from the adenoidectomy area) and consequent use of bipolar electrocautery to complete haemostasis. The need for electrocautery use was noted for each group (yes/no answer). Early postadenoidectomy haemorrhage (occurring in the first 24 h postoperatively) in both groups was inferred from OR surgical protocols (yes/no answer) and was retrospectively included in our database. These variables, together with the age and sex of each patient, were used to complete our Excel database.Choosing the studied sample size followed calculations performed by our statistical analyst and economic reasons. Moreover, it was the number of patients operated on by the 3 designated surgeons on 2 days per week during the study period of 6 months. A statistical analysis was performed on our database to compare the results between the two groups. The R project for statistical computing (R version 4.1.3), Welch’s Two Sample 