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

High-Grade Squamous Intraepithelial Lesions Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06325592
• Other study ID #: REHSIL2023V1.1
• Status: Completed
• Start date: October 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Sichuan Cancer Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 826
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma in Situ
• Carcinoma, Squamous Cell
• High-Grade Squamous Intraepithelial Lesions
• Squamous Intraepithelial Lesions of the Cervix

Intervention

Procedure:
• surgical timing and operation path
surgical timing; laparoscopic hysterectomy or abdominal hysterectomy

Locations

Country	Name	City	State
China	Sichuan Cancer Hospital and Research Institute	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Cancer Hospital and Research Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative fever	Use a thermometer to measure your temperature	Within 7 days of surgery
Primary	Postoperative therapeutic use of antibiotics	Postoperative therapeutic use of antibiotics	Within 7 days of surgery
Secondary	Postoperative complications	Postoperative complications	Within 7 days of surgery
Secondary	Postoperative hospitalization days	Postoperative hospitalization days	Date of surgery to date of discharge
Secondary	Postoperative hemoglobin	Postoperative hemoglobin	Within 7 days of surgery
Secondary	Postoperative white blood cell count	Postoperative white blood cell count	Within 7 days of surgery
Secondary	Postoperative erythrocyte count	Postoperative erythrocyte count	Within 7 days of surgery
Secondary	Postoperative albumin number	Postoperative albumin number	Within 7 days of surgery
Secondary	Postoperative CRP value	Postoperative CRP value	Within 7 days of surgery