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Completed

NCT Number: NCT03494686

LLETZ Under General Versus Local Anesthesia

The investigators conduct a prospective, randomized trial to assess the benefits of performing large loop excision of the transformatione zone (LLETZ) under local anesthesia and compare it to LLETZ under general anesthesia. The primary endpoint of this study is women´s satisfaction.

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Key information

Conditions

Uterine Cervical Dysplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology of the Ruhr University Bochum

Herne, North Rhine-Westphalia, 44625, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • colposcopy Prior to conization
  • informed consent
  • histologically proven high grade cervical dysplasia
  • Transformation zone typ 1 or 2

Exclusion criteria

  • significant language barrier
  • a personal history of conization
  • pregnancy
  • the use of blood thinner
  • unwillingness to participate
  • oncological disease
  • inpatient treatment
  • women who are not fasting
  • risk of aspiration
  • columnar-squamous epithelium border not fully visible

Treatment and study plan

LLETZ under local anaesthesia

Procedure

Conization will be performed under local anaesthesia

LLETZ under general anaesthesia

Procedure

Conization will be performed under general anaesthesia

Primary outcomes

  1. Womens satisfaction

    Time frame: 2 hours

    Patients will score their satisfaction by using a 11-step visual analogue scale (VAS) ranging from '0' ("not satisfied at all") to '10' ("very satisfied") 2 hours after Treatment

Secondary outcomes

  1. Postoperative pain

    Time frame: 2 hours

    patients will score their postoperative pain Level using a 11-step visual analogue scale (VAS) ranging from '0' ("no pain" ) to '10' ("maximum pain") within 2 hours after surgery

  2. the resected cone mass

    Time frame: 10 minutes

    the resected cone mass will be quantified by weighing the removed tissue with a precision scale located in the operating room

  3. Operation time

    Time frame: 20 minutes

    the time from the beginning of the Operation (start of the electrosurgical method) until the end of the operation (the end of hemostatic interventions) will be measured in minutes

  4. Operative complications

    Time frame: 14 days

    Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively

  5. Time to complete intraoperative hemostasis

    Time frame: 120 seconds

    the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds

  6. Surgeons satisfaction

    Time frame: 20 minutes

    Surgeons will score their satisfaction by using a 11-step visual analogue scale (VAS) 20 minutes after Treatment

  7. number of fragments of the surgical specimen

    Time frame: 20 minutes

    surgeons will count the number of the surgical specimen (1 vs. >1)

  8. the dimensions of the surgical specimens

    Time frame: 20 minutes

    The circumference, length and thickness of The surgical specimens will be measured

  9. Intraoperative blood loss

    Time frame: 5 hours

    intraoperative blood loss will be measured using the difference in serum hemoglobin one day prior to surgery and within 5 hours postoperatively

  10. Margin status

    Time frame: 2 days after conization

    Resection margin is judge as "R0" if abnormal cells are not found in the margin of the biopsy or "R1" if abnormal cells remain in the margin of the biopsy. The histopathological examination will be done by an Independent pathologist

Sponsors and collaborators

Lead sponsor

Zydolab - Institute of Cytology and Immune Cytochemistry

Other

Registry information

Official study title

Large Loop Excision of the Transformatione Zone Under General Versus Local Anesthesia: a Randomized Trial.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 11, 2018
Registry last updated
Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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