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Anesthesia on Postoperative Pain After Loop Electrosurgical Excision Procedure

NCT04984122 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2023-03-03

No results posted yet for this study

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

Conditions

  • Procedure, Gynecologic Surgical

Interventions

PROCEDURE

LEEP

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 & Collaborators

  • Erzincan Military Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-09
Primary Completion
2022-04-30
Completion
2022-08-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04984122 on ClinicalTrials.gov