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

Completed

• Conditions: High-Grade Squamous Intraepithelial Lesions
• Interventions: Procedure: surgical timing and operation path

• Registration Number: NCT06325592
• Lead Sponsor: Sichuan Cancer Hospital and Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-03
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01
• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 826

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 1	surgical timing and operation path	patients underwent laparoscopic hysterectomy within 3 days after LEEP
group 3	surgical timing and operation path	patients underwent laparoscopic hysterectomy 4 weeks after LEEP
group 2	surgical timing and operation path	patients underwent abdominal hysterectomy within 3 days after LEEP
group 4	surgical timing and operation path	underwent abdominal hysterectomy 4 weeks after LEEP

Primary Outcome Measures

Name	Time	Method
Postoperative fever	Within 7 days of surgery	Use a thermometer to measure your temperature
Postoperative therapeutic use of antibiotics	Within 7 days of surgery	Postoperative therapeutic use of antibiotics

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	Within 7 days of surgery	Postoperative complications
Postoperative erythrocyte count	Within 7 days of surgery	Postoperative erythrocyte count
Postoperative white blood cell count	Within 7 days of surgery	Postoperative white blood cell count
Postoperative hospitalization days	Date of surgery to date of discharge	Postoperative hospitalization days
Postoperative CRP value	Within 7 days of surgery	Postoperative CRP value
Postoperative albumin number	Within 7 days of surgery	Postoperative albumin number
Postoperative hemoglobin	Within 7 days of surgery	Postoperative hemoglobin

Trial Locations

Locations (1)

Sichuan Cancer Hospital and Research Institute; 🇨🇳 Chengdu, Sichuan, China