Procedure, Gynecologic Surgical
Conditions
Brief summary
The loop electrosurgical excision procedure (LEEP) is a modified cervical conization that is performed with an electrosurgical loop. It may be performed under local anesthesia (LA) or under general anesthesia (GA), and practice patterns differ widely. In some countries, specific guidelines for the choice of anesthesia during LEEP are provided, whereas, in other countries, the choice of anesthesia is not specified. LEEP under LA is more economical, obviating the need for anesthesia staff, equipment, and operating room fees. However, LEEP under LA may be more difficult to perform, may be more difficult to learn, may lead to inferior surgical results, and may result in more pain and patient dissatisfaction. This study aimed to compare loop electrosurgical excision procedures under local anesthesia vs general anesthesia regarding patients' satisfaction, histopathologic results, and short-term morbidity
Interventions
PROCEDURELEEP
According to the size of the cervix, a loop electrode size was selected. The electrical power for the loop electrode was set to 50 W cut and 45 W coagulation in blended mode. LEEP was performed by carefully passing the loop around the transformation zone from 12 o'clock to 6 o'clock. An additional top-hat excision was performed in patients with a lesion deep in the cervical canal. After completion of the excision, hemostasis was exclusively obtained using the ball electrode in spray coagulation mode. No suturing or other methods were used for hemostasis.
Sponsors
Erzincan Military Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients were \> 21 years old; were not pregnant The patient had one of the following indications for LEEP: 1. histologyproven, persistent, low-grade squamous intraepithelial lesion (LGSIL); 2. a histology-proven high-grade squamous intraepithelial lesion (HGSIL); 3. discrepancies between cytological reports and colposcopic impressions; 4. investigation for unsatisfactory colposcopy; 5. microinvasion or adenocarcinoma in situ on cervical punch biopsy.
Exclusion criteria
Patients with cervical or vaginal infection; Patients with an abnormal menstrual cycle; who were taking anticoagulants, Patients with a coagulation defect Patients with mental incapacity Patients with previous hysterectomy with removal of the cervix Patients with a history of cervical cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual analog scale 1 | up to 1 hour after the procedure | VAS score ( 0 cm = no pain, 10 cm = worst pain imaginable) reported for the pain felt at 1 hour after procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| visual analog scale 2 | up to 2 hour after the procedure | VAS score ( 0 cm = no pain, 10 cm = worst pain imaginable) reported for the pain felt at 2 hours after LEEP |
Countries
Turkey (Türkiye)
Outcome results
None listed