Syringe or mask? Loop electrosurgical excision procedure under local or general anesthesia: a randomized trial.

BACKGROUND: Loop electrosurgical excision procedure may be performed under local anesthesia or general anesthesia, and practice patterns differ worldwide. No randomized head-to-head comparison has been published to confirm or refute either practice. OBJECTIVE: This study aimed to compare loop electrosurgical excision procedure under local anesthesia vs general anesthesia regarding patient satisfaction and procedure-related outcomes such as rates of involved margins, complications, pain, and blood loss. STUDY DESIGN: Consecutive women referred to our colposcopy unit were recruited. Loop electrosurgical excision procedure was performed under local anesthesia with 4 intracervical injections of bupivacaine hydrochloride 0.5% or under general anesthesia with fentanyl, propofol, and a laryngeal mask with sevoflurane maintenance. The primary endpoint was patient satisfaction assessed on the day of surgery and 14 days thereafter using a Likert scale (score 0-100) and a questionnaire. Secondary endpoints included rates of involved margins, procedure-related complications, pain, blood loss, and surgeon preference. Results were compared using nonparametric and chi-square tests. RESULTS: Between July 2018 and February 2020, we randomized 208 women, 108 in the local anesthesia arm and 100 in the general anesthesia arm. In the intention-to-treat analysis, patient satisfaction did not differ between the study groups directly after surgery (Likert scale 100 [90-100] vs 100 [90-100]; P=.077) and 14 days thereafter (Likert scale 100 [80-100] vs 100 [90-100]; P=.079). In the per-protocol analysis, women in the local anesthesia arm had significantly smaller cone volumes (1.11 cm3 [0.70-1.83] vs 1.58 cm3 [1.08-2.69], respectively; P<.001), less intraoperative blood loss (Δhemoglobin, 0.2 g/dL [-0.1 to 0.4] vs 0.5 g/dL [0.2-0.9]; P<.001), and higher satisfaction after 14 days (100 [90-100] vs 100 [80-100]; P=.026), whereas surgeon preference favored general anesthesia (90 [79-100] vs 100 [90-100], respectively; P=.001). All other secondary outcomes did not differ between groups (resection margin status R1, 6.6% vs 2.1% [P=.26]; cone fragmentation, 12.1% vs 6.3% [P=.27]; procedure duration, 151.5 seconds [120-219.5] vs 180 seconds [117-241.5] [P=.34]; time to complete hemostasis, 60 seconds [34-97] vs 70 seconds [48.25-122.25] [P=.08]; complication rate, 3.3% vs 1.1% [P=.59]). In a multivariate analysis, parity (P=.03), type of transformation zone (P=.03), and cone volume (P=.02) and not study group assignment, age, body mass index, and degree of dysplasia independently influenced the primary endpoint. CONCLUSION: Loop electrosurgical excision procedure under local anesthesia is equally well tolerated and offers patient-reported and procedure-related benefits over general anesthesia, supporting the preferred practice in some institutions and refuting the preferred practice in others.

Análisis prospectivo de LEEP realizados sin anestesia en la consulta de patología cervical / Prospective analyses of outpatient LEEP carried out in cervical pathology clinic without anesthesia

Objetivo: determinar si la técnica Loop Electrosurgical Excision Procedure es un procedimiento efectivo y seguro para realizarlo en consulta ambulatoria de patología cervical. Material y métodos: estudio observacional prospectivo que incluye 156 pacientes que se les realiza Loop Electrosurgical Excision Procedure en consulta ambulatoria, sin anestesia, durante un periodo de seguimiento de 84 meses (7 años). Se excluyen 24 pacientes. Se analizan diferentes variables epidemiológicas, técnica, estado de bordes quirúrgicos, complicaciones y tolerancia al dolor. Resultados: la edad media de las pacientes fue de 35,7 años con inicio de la actividad sexual 17,9 años y 9 parejas sexuales de media. El diámetro mayor de las piezas analizadas fue de 1,7 cm. En el 18 pacientes (13,6%) los bordes quirúrgicos fueron reportados "afectos". Presentamos en 3 casos (2,3%) daño de la mucosa vaginal y un caso (0,8%) hemorragia tardía. La tolerancia al dolor fue satisfactoria en 121 pacientes (91,7%) y solo 1 paciente (0,8%) precisó de anestésico local. Discusión: el Loop Electrosurgical Excision Procedure es un procedimiento que puede ser realizado en consulta bajo imagen colposcopica en forma segura, efectiva y sin anestesia (AU)

Objective: To determine if cervical conization realized by leep procedure is an effective and safe procedure in an outpatient cervical pathology clinic. Material and methods: Prospective cohort study which includes 156 patients, who experienced a Loop Electrosurgical Excision Procedure procedure in an outpatient clinic without anesthesia, in a 84 months follow-up period (7 years). 24 patients are excluded. Different epidemiological variables and techniques were analyzed, as well as excision margins state, complications and pain tolerance. Results: The patients average age were 35.7 years old, with an onset of sexual activity median age of 17.9 years and a average number 9 sexual partners. The largest diameter of the analyzed pieces was 1.7 cm. In 18 patients (13.6%), excision margins were reported as "affected". In 3 cases (2.3%) the vaginal mucosa became damaged and one patient (0.8%) had late bleeding. The pain tolerance was satisfactory in 91.7% cases and local anaesthetic was administered to one patient only (0.8%). Discussion: Loop Electrosurgical Excision Procedure procedure can be carried out in an outpatient clinic under colposcopic vision being a safe, effective and without need of anesthesia procedure (AU)