Syringe or Mask? Loop Electrosurgical Excision Procedure Under Local or General Anesthesia: A Randomized Trial

The loop electrosurgical excision procedure (LEEP) is one of the most commonly performed gynecological surgeries. The procedure can be performed either under local anesthesia (LA) or general anesthesia (GA). Worldwide, practice patterns vary across hospitals and countries. It has been generally believed that LEEP under GA leads to a higher degree of patient satisfaction. Presently, no high-level evidence is available from randomized controlled trials showing the superiority or inferiority of either approach regarding patient-reported outcomes and procedure-related outcomes. It is important to clarify whether LEEP under LA is superior to GAwith regard to the quality of surgical care and patient satisfaction. There are no published randomized head-to-head studies comparing these methods. The aim of this prospective randomized study was to compare in women with cervical dysplasia LEEP performed under GAwith LEEP under LAwith regard to patient satisfaction and procedure-related outcomes such as rates of involvedmargins, complications, pain, and blood loss. Consecutive women with cervical dysplasia were referred to the colposcopy unit at a Department of Obstetrics and Gynecology in Germany. Participants were women with a biopsy-proven, low- or high-grade squamous intraepithelial lesion who were scheduled for LEEP. In addition, women undergoing diagnostic LEEP after an abnormal Pap smear result and inconclusive colposcopy were included. In an outpatient setting, patients undergoing LEEP received 4 intracervical injections of bupivacaine hydrochloride 0.5% (LA) or GAwith fentanyl, propofol, and a laryngeal mask with sevoflurane maintenance (GA). The primary study endpoint-patient satisfaction on the day of surgery and at 14 days after surgery-was assessed using a Likert scale (score range, 0-100) and a postprocedure questionnaire. Secondary endpoints evaluated included resection margin status of the surgical specimen (involved margin [R1] vs free margin [R0]), intraoperative blood loss, time to complete hemostasis, cone volume and fragmentation, intraoperative and postoperative complications, and surgeon preference. Nonparametric and.2 tests were used to compare results. The study was not blinded because of the study design. Between July 2018 and February 2020, 208 women were randomized: 108 to the LA arm and 100 to the GA arm. In the intention-to-treat analysis, there was no significant difference between study groups in patient satisfaction directly after surgery (Likert scale 100 [90-100] vs 100 [90-100]; not statistically significant) and 14 days after surgery (Likert scale 100 [80-100] vs 100 [90-100]; not statistically significant). In the per-protocol analysis, women in the LA group had significantly smaller cone volumes than those in the GA group (1.11; 95% confidence interval [CI], [0.70-1.83] vs 1.58 [95% CI, 1.08-2.69] cm3, respectively; P < 0.001), less intraoperative blood loss (difference in hemoglobin levels, 0.2; 95% CI, [95% CI, -0.1 to -0.4] vs 0.5 [95% CI, 0.2-0.9]; P < 0.001), and higher satisfaction 14 days after surgery (100 [95% CI, 90-100] vs 100 [95% CI, 80-100]; P = 0.026), whereas surgeons preferred GA (90 [95% CI, 79-100] vs 100 [95% CI, 90-100], respectively; P = 0.001). There was no statistically significant difference between groups for all other secondary outcomes (resection margin involvement: 6.6% vs 2.1%; cone fragmentation: 12.1% vs 6.3%; procedure duration: 151.5 [95% CI, 120-219.5] vs 180 [95% CI, 117-241.5] seconds; time to complete hemostasis: 60 [95% CI, 34-97] vs 70 [95% CI, 48.25-122.25] seconds; complication rate: 3.3% vs 1.1%). Multivariate analysis showed that the primary outcome, patient satisfaction, was associated with parity (P = 0.03), type of transformation zone (P = 0.03), and cone volume (P = 0.02), but not study group assignment, age, body mass index, and degree of dysplasia. This randomized trial demonstrates that LEEP under LA offers patient-reported as well as procedure-related benefits over GA and is equally well tolerated. The findings should be incorporated into clinical practice guidelines in settings where LEEP under GA is the current standard of care.