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OpenTrials
Completed

NCT Number: NCT06325592

Association Between Surgical Timing and Route of Total Hysterectomy After LEEP and Perioperative Risk in Patients With Cervical HSIL

This study aimed to analyze perioperative information in patients with high-grade squamous intraepithelial lesion (HSIL) undergoing total hysterectomy (TH), offering insights into optimal surgery timing, selecting the operation path, and enhancing surgical operation details.

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Key information

Conditions

High-Grade Squamous Intraepithelial Lesions Morphological and Microscopic Findings Pathological Conditions, Signs and Symptoms Squamous Intraepithelial Lesions

Sex eligibility

Female

Study type

Observational

Primary location

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, 610000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients were confirmed with HSIL through pathology at our hospital or another tertiary facility, with additional confirmation via pathological consultation at our facility;
  • LH or abdominal hysterectomy (AH) +/- bilateral fallopian tube or bilateral adnexectomy was performed after LEEP;
  • the patient had no history of systemic malignancies.

Exclusion criteria

  • severe medical and surgical complications;
  • an extensive or subextensive hysterectomy was performed;
  • surgical removal scope involving tissues (such as lymph nodes) or organs (such as the appendix) other than the uterus, ovaries, and fallopian tubes;
  • fever symptoms within the last month;
  • incidence of pelvic and abdominal infections, vaginitis, or similar conditions within the past month.

Treatment and study plan

surgical timing and operation path

Procedure

surgical timing; laparoscopic hysterectomy or abdominal hysterectomy

Primary outcomes

  1. Postoperative fever

    Time frame: Within 7 days of surgery

    Use a thermometer to measure your temperature

  2. Postoperative therapeutic use of antibiotics

    Time frame: Within 7 days of surgery

    Postoperative therapeutic use of antibiotics

Secondary outcomes

  1. Postoperative complications

    Time frame: Within 7 days of surgery

    Postoperative complications

  2. Postoperative hospitalization days

    Time frame: Date of surgery to date of discharge

    Postoperative hospitalization days

  3. Postoperative hemoglobin

    Time frame: Within 7 days of surgery

    Postoperative hemoglobin

  4. Postoperative white blood cell count

    Time frame: Within 7 days of surgery

    Postoperative white blood cell count

  5. Postoperative erythrocyte count

    Time frame: Within 7 days of surgery

    Postoperative erythrocyte count

  6. Postoperative albumin number

    Time frame: Within 7 days of surgery

    Postoperative albumin number

  7. Postoperative CRP value

    Time frame: Within 7 days of surgery

    Postoperative CRP value

Sponsors and collaborators

Lead sponsor

Sichuan Cancer Hospital and Research Institute

Other

Registry information

Official study title

Association Between Surgical Timing and Route of Total Hysterectomy After Loop Electrosurgical Excision Procedure and Perioperative Risk in Patients With Cervical High-grade Squamous Intraepithelial Lesion

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 22, 2024
Registry last updated
Mar 22, 2024

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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